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Trial record 1 of 1 for:    GS-US-418-3898
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Study to Evaluate the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Ulcerative Colitis (SELECTION)

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ClinicalTrials.gov Identifier: NCT02914522
Recruitment Status : Completed
First Posted : September 26, 2016
Results First Posted : April 21, 2021
Last Update Posted : April 21, 2021
Sponsor:
Collaborator:
Galapagos NV
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Ulcerative Colitis
Interventions Drug: Filgotinib
Drug: PTM filgotinib
Enrollment 1351
Recruitment Details Participants were enrolled at study sites in Australia, New Zealand, North America, South America, Asia and Europe. The first participant was screened on 14 November 2016. The last study visit occurred on 31 March 2020.
Pre-assignment Details 2040 participants were screened.
Arm/Group Title Induction Study (Cohort A): Filgotinib 200 mg Induction Study (Cohort A): Filgotinib 100 mg Induction Study (Cohort A): Placebo Induction Study (Cohort B): Filgotinib 200 mg Induction Study (Cohort B): Filgotinib 100 mg Induction Study (Cohort B): Placebo Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg Maintenance Study: Placebo From Induction Filgotinib 200 mg Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg Maintenance Study: Placebo From Induction Filgotinib 100 mg Maintenance Study: Placebo From Induction Placebo
Hide Arm/Group Description Participants in Cohort A (biologic-naive) received filgotinib 200 milligrams (mg) and placebo-to-match (PTM) filgotinib 100 mg orally once daily for 10 weeks. Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks. Participants in Cohort A (biologic-naive) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks. Participants in Cohort B (biologic-experienced) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either Endoscopy/Bleeding/Stool Frequency (EBS) remission or Mayo Clinic Score (MCS) response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for an additional 47 weeks (up to Week 58). Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58). Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for an additional 47 weeks (up to Week 58). Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were rerandomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58). Participants in the Placebo arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
Period Title: Induction Study: Up to Week 11
Started 245 278 137 262 286 143 0 0 0 0 0
Completed 235 256 127 234 262 127 0 0 0 0 0
Not Completed 10 22 10 28 24 16 0 0 0 0 0
Reason Not Completed
Adverse Event             5             6             4             18             14             10             0             0             0             0             0
Withdrew Consent             4             11             4             6             3             3             0             0             0             0             0
Protocol Violation             0             2             1             3             4             2             0             0             0             0             0
Lost to Follow-up             0             2             1             1             0             0             0             0             0             0             0
Investigator's Discretion             0             0             0             0             1             0             0             0             0             0             0
Non-compliance With Study Drug             1             0             0             0             0             0             0             0             0             0             0
Pregnancy             0             0             0             0             1             0             0             0             0             0             0
Did not Receive Study Drug             0             1             0             0             1             1             0             0             0             0             0
Period Title: Maintenance Study: Week 11 to Week 58
Started 0 [1] 0 [1] 0 [1] 0 0 0 [1] 202 [1] 99 [1] 179 [1] 91 [1] 93
Completed 0 0 0 0 0 0 150 41 104 42 64
Not Completed 0 0 0 0 0 0 52 58 75 49 29
Reason Not Completed
Protocol-specified Disease Worsening             0             0             0             0             0             0             34             49             53             39             21
Adverse Event             0             0             0             0             0             0             7             2             10             4             3
Protocol Violation             0             0             0             0             0             0             5             5             3             0             1
Withdrew Consent             0             0             0             0             0             0             4             1             6             3             4
Death             0             0             0             0             0             0             2             0             0             0             0
Investigator's Discretion             0             0             0             0             0             0             0             1             2             0             0
Pregnancy             0             0             0             0             0             0             0             0             1             2             0
Non-compliance With Study Drug             0             0             0             0             0             0             0             0             0             1             0
[1]
Participants achieved either EBS remission/MCS response at Week 10 continued into Maintenance Study.
Arm/Group Title Induction Study (Cohort A): Filgotinib 200 mg Induction Study (Cohort A): Filgotinib 100 mg Induction Study (Cohort A): Placebo Induction Study (Cohort B): Filgotinib 200 mg Induction Study (Cohort B): Filgotinib 100 mg Induction Study (Cohort B): Placebo Total
Hide Arm/Group Description Participants in Cohort A (biologic-naive) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks. Participants in Cohort A (biologic-naive) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks. Participants in Cohort B (biologic-experienced) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. Total of all reporting groups
Overall Number of Baseline Participants 245 277 137 262 285 142 1348
Hide Baseline Analysis Population Description
Safety Analysis Set for the Induction Study (Cohorts A and B) included all participants who took at least 1 dose of study drug in the Induction Study.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 245 participants 277 participants 137 participants 262 participants 285 participants 142 participants 1348 participants
<=18 years 0 0 0 0 0 0 0
Between 18 and 65 years 234 261 129 243 264 128 1259
>=65 years 11 16 8 19 21 14 89
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 245 participants 277 participants 137 participants 262 participants 285 participants 142 participants 1348 participants
Female 122 120 50 114 99 56 561
Male 123 157 87 148 186 86 787
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 245 participants 277 participants 137 participants 262 participants 285 participants 142 participants 1348 participants
American Indian or Alaska Native 1 0 0 0 0 0 1
Asian 77 79 38 50 51 27 322
Black or African American 2 3 1 4 6 3 19
White 165 192 95 190 212 98 952
Other 0 2 2 0 0 1 5
Not Permitted 0 1 1 18 16 13 49
[1]
Measure Description: Not Permitted = local regulators did not allow collection of race or ethnicity information.
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Ethnicity Number Analyzed 245 participants 277 participants 137 participants 262 participants 285 participants 142 participants 1348 participants
Not Hispanic or Latino 238 269 134 249 273 134 1297
Hispanic or Latino 6 6 3 8 8 4 35
Not Permitted 1 2 0 5 4 4 16
[1]
Measure Description: Not Permitted = local regulators did not allow collection of race or ethnicity information.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 245 participants 277 participants 137 participants 262 participants 285 participants 142 participants 1348 participants
Poland 57 56 25 17 22 11 188
United States 14 33 19 36 58 21 181
India 55 49 27 8 3 3 145
Japan 15 16 6 29 29 14 109
Ukraine 33 46 24 1 2 0 106
France 1 1 1 32 26 19 80
Germany 1 3 0 31 26 9 70
Russia 21 10 12 6 9 1 59
Italy 4 6 1 15 19 12 57
United Kingdom 7 3 0 12 11 7 40
Belgium 0 0 0 16 14 6 36
South Korea 1 7 2 5 12 5 32
Australia 6 3 1 10 8 2 30
Hungary 9 8 3 0 5 2 27
Romania 3 3 2 3 5 3 19
Switzerland 0 0 0 7 5 7 19
Canada 2 2 1 3 5 4 17
Czechia 3 4 4 4 2 0 17
Taiwan 1 3 0 4 4 0 12
Israel 1 1 0 5 4 0 11
New Zealand 1 2 0 4 2 1 10
South Africa 0 3 2 2 1 0 8
Spain 0 1 0 1 4 2 8
Austria 0 0 0 3 2 2 7
Croatia 0 1 0 2 1 2 6
Norway 0 2 2 1 1 0 6
Sweden 0 0 1 1 1 3 6
Bulgaria 1 3 1 0 0 0 5
Greece 1 1 0 0 2 1 5
Georgia 1 2 1 0 0 0 4
Hong Kong 2 1 0 1 0 0 4
Netherlands 0 0 0 2 0 2 4
Serbia 1 2 1 0 0 0 4
Slovakia 2 0 0 0 0 2 4
Argentina 1 1 0 1 0 0 3
Malaysia 0 2 1 0 0 0 3
Ireland 0 0 0 0 1 1 2
Portugal 0 1 0 0 1 0 2
Mexico 1 0 0 0 0 0 1
Singapore 0 1 0 0 0 0 1
1.Primary Outcome
Title Induction Study: Percentage of Participants Who Achieved Endoscopy/Bleeding/Stool Frequency (EBS) Remission at Week 10
Hide Description EBS remission was defined as an endoscopic subscore of 0 or 1; rectal bleeding subscore of 0; and at least a 1-point decrease in stool frequency from baseline to achieve a subscore of 0 or 1. Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration); rectal bleeding subscore range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes; stool frequency subscore range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal. Total score for EBS ranged from 0 to 9 (sum of all subscores), with higher scores indicating more severe disease.
Time Frame Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set for the Induction study (Cohorts A and B) included all randomized participants who took at least 1 dose of study drug in the corresponding Induction study.
Arm/Group Title Induction Study (Cohort A): Filgotinib 200 mg Induction Study (Cohort A): Filgotinib 100 mg Induction Study (Cohort A): Placebo Induction Study (Cohort B): Filgotinib 200 mg Induction Study (Cohort B): Filgotinib 100 mg Induction Study (Cohort B): Placebo
Hide Arm/Group Description:
Participants in Cohort A (biologic-naive) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
Participants in Cohort A (biologic-naive) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
Participants in Cohort B (biologic-experienced) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
Overall Number of Participants Analyzed 245 277 137 262 285 142
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
26.1
(20.4 to 31.8)
19.1
(14.3 to 23.9)
15.3
(8.9 to 21.7)
11.5
(7.4 to 15.5)
9.5
(5.9 to 13.0)
4.2
(0.6 to 7.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort A): Filgotinib 200 mg, Induction Study (Cohort A): Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0157
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel(CMH) test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and immunomodulators (Yes/No) at Day 1.
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 10.8
Confidence Interval (2-Sided) 95%
2.1 to 19.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort A): Filgotinib 100 mg, Induction Study (Cohort A): Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3379
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 3.8
Confidence Interval (2-Sided) 95%
-4.3 to 12.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort B): Filgotinib 200 mg, Induction Study (Cohort B): Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0103
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,>1).
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 7.2
Confidence Interval (2-Sided) 95%
1.6 to 12.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort B): Filgotinib 100 mg, Induction Study (Cohort B): Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0645
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,>1).
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 5.2
Confidence Interval (2-Sided) 95%
-0.0 to 10.5
Estimation Comments [Not Specified]
2.Primary Outcome
Title Maintenance Study: Percentage of Participants Who Achieved EBS Remission at Week 58
Hide Description EBS remission was defined as an endoscopic subscore of 0 or 1; rectal bleeding subscore of 0; and at least a 1-point decrease in stool frequency from baseline to achieve a subscore of 0 or 1. Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration); rectal bleeding subscore range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes; stool frequency subscore range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal. Total score for EBS ranged from 0 to 9 (sum of all subscores), with higher scores indicating more severe disease.
Time Frame Week 58
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set for the Maintenance Study included all participants randomized to either the filgotinib 200 mg or filgotinib 100 mg treatment groups in the Induction Study (Cohorts A and B) who achieved EBS remission or MCS response at Week 10, were rerandomized, and took at least 1 dose of study drug in the Maintenance Study.
Arm/Group Title Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg Maintenance Study: Placebo From Induction Filgotinib 200 mg Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg Maintenance Study: Placebo From Induction Filgotinib 100 mg
Hide Arm/Group Description:
Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for an additional 47 weeks (up to Week 58).
Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for an additional 47 weeks (up to Week 58).
Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were rerandomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
Overall Number of Participants Analyzed 199 98 172 89
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
37.2
(30.2 to 44.2)
11.2
(4.5 to 18.0)
23.8
(17.2 to 30.5)
13.5
(5.8 to 21.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg, Maintenance Study: Placebo From Induction Filgotinib 200 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 26.0
Confidence Interval (2-Sided) 95%
16.0 to 35.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg, Maintenance Study: Placebo From Induction Filgotinib 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0420
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 10.4
Confidence Interval (2-Sided) 95%
-0.0 to 20.7
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Induction Study: Percentage of Participants Who Achieved MCS Remission at Week 10
Hide Description MCS remission was defined as having a MCS of 2 or less and no single subscore higher than 1. The MCS was composed of subscores from endoscopy (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease [spontaneous bleeding, ulceration]), rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), and physician's global assessment (PGA). The PGA acknowledged the participant's daily recollection of abdominal discomfort and general sense of wellbeing, and other observations, such as physical findings and the participant's performance status. The PGA score ranged from 0 to 3 with higher score indicating the severe disease. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating more severe disease.
Time Frame Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set for the Induction Study (Cohorts A and B) were analyzed.
Arm/Group Title Induction Study (Cohort A): Filgotinib 200 mg Induction Study (Cohort A): Filgotinib 100 mg Induction Study (Cohort A): Placebo Induction Study (Cohort B): Filgotinib 200 mg Induction Study (Cohort B): Filgotinib 100 mg Induction Study (Cohort B): Placebo
Hide Arm/Group Description:
Participants in Cohort A (biologic-naive) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
Participants in Cohort A (biologic-naive) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
Participants in Cohort B (biologic-experienced) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
Overall Number of Participants Analyzed 245 277 137 262 285 142
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
24.5
(18.9 to 30.1)
17.0
(12.4 to 21.6)
12.4
(6.5 to 18.3)
9.5
(5.8 to 13.3)
6.0
(3.0 to 8.9)
4.2
(0.6 to 7.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort A): Filgotinib 200 mg, Induction Study (Cohort A): Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0053
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 12.1
Confidence Interval (2-Sided) 95%
3.8 to 20.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort A): Filgotinib 100 mg, Induction Study (Cohort A): Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2295
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 4.6
Confidence Interval (2-Sided) 95%
-3.1 to 12.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort B): Filgotinib 200 mg, Induction Study (Cohort B): Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0393
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,>1).
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 5.3
Confidence Interval (2-Sided) 95%
-0.1 to 10.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort B): Filgotinib 100 mg, Induction Study (Cohort B): Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5308
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,>1).
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 1.7
Confidence Interval (2-Sided) 95%
-3.1 to 6.6
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Induction Study: Percentage of Participants Who Achieved an Endoscopic Subscore of 0 at Week 10
Hide Description Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration).
Time Frame Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set for the Induction Study (Cohorts A and B) were analyzed.
Arm/Group Title Induction Study (Cohort A): Filgotinib 200 mg Induction Study (Cohort A): Filgotinib 100 mg Induction Study (Cohort A): Placebo Induction Study (Cohort B): Filgotinib 200 mg Induction Study (Cohort B): Filgotinib 100 mg Induction Study (Cohort B): Placebo
Hide Arm/Group Description:
Participants in Cohort A (biologic-naive) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
Participants in Cohort A (biologic-naive) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
Participants in Cohort B (biologic-experienced) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
Overall Number of Participants Analyzed 245 277 137 262 285 142
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
12.2
(7.9 to 16.6)
5.8
(2.8 to 8.7)
3.6
(0.1 to 7.2)
3.4
(1.0 to 5.8)
2.1
(0.3 to 3.9)
2.1
(0.0 to 4.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort A): Filgotinib 200 mg, Induction Study (Cohort A): Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0047
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 8.6
Confidence Interval (2-Sided) 95%
2.9 to 14.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort A): Filgotinib 100 mg, Induction Study (Cohort A): Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3495
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 2.1
Confidence Interval (2-Sided) 95%
-2.6 to 6.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort B): Filgotinib 200 mg, Induction Study (Cohort B): Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4269
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,>1).
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 1.3
Confidence Interval (2-Sided) 95%
-2.5 to 5.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort B): Filgotinib 100 mg, Induction Study (Cohort B): Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9987
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,>1).
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value -0.0
Confidence Interval (2-Sided) 95%
-3.4 to 3.4
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Induction Study: Percentage of Participants Who Achieved Geboes Histologic Remission at Week 10
Hide Description Geboes histologic remission was assessed using the Geboes histologic scores for evaluation of disease severity in ulcerative colitis and classifies histologic changes. Remission was defined as having Grade 0 of <= 0.3, Grade 1 of <= 1.1, Grade 2A of <= 2A.3, Grade 2B of 2B.0, Grade 3 of 3.0, Grade 4 of 4.0, and Grade 5 of 5.0. Possible scores are Grade 0: Architectural changes (0.0=No abnormality to 0.3=Severe diffuse or multifocal abnormalities); Grade 1: Chronic inflammatory infiltrate (1.0=No increase to 1.3=Marked increase); Grade 2A: Eosinophils in lamina propria (2A.0=No increase to 2A.3-=Marked increase; Grade 2B: Neutrophils in lamina propria (2B.0= No increase to 2B.3=Marked increase); Grade 3: Neutrophils in epithelium (3.0=None to 3.3=>50% crypts involved); Grade 4: Crypt destruction (4.0=none to 4.3=Unequivocal crypt destruction), and Grade 5: Erosions and ulcerations: (5.0=No erosion, ulceration or granulation to 5.4=Ulcer or granulation tissue).
Time Frame Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set for the Induction study (Cohorts A and B) were analyzed.
Arm/Group Title Induction Study (Cohort A): Filgotinib 200 mg Induction Study (Cohort A): Filgotinib 100 mg Induction Study (Cohort A): Placebo Induction Study (Cohort B): Filgotinib 200 mg Induction Study (Cohort B): Filgotinib 100 mg Induction Study (Cohort B): Placebo
Hide Arm/Group Description:
Participants in Cohort A (biologic-naive) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
Participants in Cohort A (biologic-naive) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
Participants in Cohort B (biologic-experienced) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
Overall Number of Participants Analyzed 245 277 137 262 285 142
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
35.1
(28.9 to 41.3)
23.8
(18.6 to 29.0)
16.1
(9.5 to 22.6)
19.8
(14.8 to 24.9)
13.7
(9.5 to 17.8)
8.5
(3.5 to 13.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort A): Filgotinib 200 mg, Induction Study (Cohort A): Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 19.0
Confidence Interval (2-Sided) 95%
9.9 to 28.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort A): Filgotinib 100 mg, Induction Study (Cohort A): Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0672
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 7.8
Confidence Interval (2-Sided) 95%
-0.7 to 16.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort B): Filgotinib 200 mg, Induction Study (Cohort B): Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0019
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,>1).
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 11.4
Confidence Interval (2-Sided) 95%
4.2 to 18.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort B): Filgotinib 100 mg, Induction Study (Cohort B): Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1286
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,>1).
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 5.2
Confidence Interval (2-Sided) 95%
-1.4 to 11.8
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Induction Study: Percentage of Participants Who Achieved MCS Remission (Alternative Definition) at Week 10
Hide Description MCS remission (alternative definition) was defined as having rectal bleeding, stool frequency, and PGA subscores of 0 and an endoscopic subscore of 0 or 1; overall MCS of ≤ 1. MCS possible subscores: rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), PGA subscore (range: 0 to 3 with higher score indicating the severe disease), and an endoscopic subscore (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease [spontaneous bleeding, ulceration]. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating more severe disease.
Time Frame Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set for the Induction Study (Cohorts A and B) were analyzed.
Arm/Group Title Induction Study (Cohort A): Filgotinib 200 mg Induction Study (Cohort A): Filgotinib 100 mg Induction Study (Cohort A): Placebo Induction Study (Cohort B): Filgotinib 200 mg Induction Study (Cohort B): Filgotinib 100 mg Induction Study (Cohort B): Placebo
Hide Arm/Group Description:
Participants in Cohort A (biologic-naive) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
Participants in Cohort A (biologic-naive) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
Participants in Cohort B (biologic-experienced) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
Overall Number of Participants Analyzed 245 277 137 262 285 142
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
12.2
(7.9 to 16.6)
8.7
(5.2 to 12.2)
4.4
(0.6 to 8.2)
3.8
(1.3 to 6.3)
2.1
(0.3 to 3.9)
2.1
(0.0 to 4.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort A): Filgotinib 200 mg, Induction Study (Cohort A): Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0105
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 7.9
Confidence Interval (2-Sided) 95%
1.9 to 13.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort A): Filgotinib 100 mg, Induction Study (Cohort A): Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1062
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 4.3
Confidence Interval (2-Sided) 95%
-1.0 to 9.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort B): Filgotinib 200 mg, Induction Study (Cohort B): Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3084
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,>1).
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 1.7
Confidence Interval (2-Sided) 95%
-2.2 to 5.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Induction Study (Cohort B): Filgotinib 100 mg, Induction Study (Cohort B): Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9109
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments CMH was stratified by concomitant use of corticosteroids and of immunomodulators at Day 1, and number of prior exposure to biologic agent (≤1,>1).
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value -0.0
Confidence Interval (2-Sided) 95%
-3.4 to 3.4
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Induction Study: Pharmacokinetic (PK) Parameter: Cmax of Filgotinib and Its Metabolite GS-829845
Hide Description Cmax is defined as the maximum observed concentration of drug.
Time Frame Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
PK Substudy Analysis Set included all randomized participants who took at least 1 dose of filgotinib, participated in the PK substudy, and had at least 1 nonmissing intensive concentration value for filgotinib and/or GS-829845 with available data were analyzed.
Arm/Group Title Induction Study (Cohort A): Filgotinib 200 mg Induction Study (Cohort A): Filgotinib 100 mg Induction Study (Cohort B): Filgotinib 200 mg Induction Study (Cohort B): Filgotinib 100 mg
Hide Arm/Group Description:
Participants in Cohort A (biologic-naive) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
Overall Number of Participants Analyzed 4 11 9 17
Mean (Standard Deviation)
Unit of Measure: nanograms per milliliter (ng/mL)
Filgotinib Number Analyzed 4 participants 10 participants 9 participants 17 participants
1746.3  (1244.05) 725.1  (313.36) 2283.3  (1012.03) 977.9  (403.51)
Metabolite GS-829845 Number Analyzed 4 participants 11 participants 9 participants 17 participants
3227.5  (1204.50) 1812.2  (701.46) 4373.3  (1121.58) 2002.9  (598.73)
8.Secondary Outcome
Title Induction Study: PK Parameter: Tmax of Filgotinib and Its Metabolite GS-829845
Hide Description Tmax is defined as the time to reach maximum observed concentration of drug.
Time Frame Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Substudy Analysis Set with available data were analyzed.
Arm/Group Title Induction Study (Cohort A): Filgotinib 200 mg Induction Study (Cohort A): Filgotinib 100 mg Induction Study (Cohort B): Filgotinib 200 mg Induction Study (Cohort B): Filgotinib 100 mg
Hide Arm/Group Description:
Participants in Cohort A (biologic-naive) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
Overall Number of Participants Analyzed 4 11 9 17
Median (Full Range)
Unit of Measure: hour (h)
Filgotinib Number Analyzed 4 participants 10 participants 9 participants 17 participants
1.50
(0.75 to 2.00)
0.75
(0.50 to 3.00)
1.00
(0.50 to 2.25)
0.57
(0.42 to 3.00)
Metabolite GS-829845 Number Analyzed 4 participants 11 participants 9 participants 17 participants
3.76
(2.00 to 4.00)
3.00
(1.00 to 6.00)
3.02
(2.13 to 6.00)
3.00
(1.03 to 6.00)
9.Secondary Outcome
Title Induction Study: PK Parameter: AUCtau of Filgotinib and Its Metabolite GS-82984
Hide Description AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Time Frame Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Substudy Analysis Set with available data were analyzed.
Arm/Group Title Induction Study (Cohort A): Filgotinib 200 mg Induction Study (Cohort A): Filgotinib 100 mg Induction Study (Cohort B): Filgotinib 200 mg Induction Study (Cohort B): Filgotinib 100 mg
Hide Arm/Group Description:
Participants in Cohort A (biologic-naive) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
Overall Number of Participants Analyzed 4 11 9 17
Mean (Standard Deviation)
Unit of Measure: hour*nanograms per milliliter (h*ng/mL)
Filgotinib Number Analyzed 4 participants 10 participants 8 participants 15 participants
5501.3  (1956.39) 1909.3  (788.13) 6475.6  (1643.00) 2492.3  (852.52)
Metabolite GS-829845 Number Analyzed 4 participants 10 participants 7 participants 15 participants
57982.0  (17767.52) 31187.9  (11858.78) 80208.6  (25096.57) 36075.6  (13396.86)
10.Secondary Outcome
Title Induction Study: PK Parameter: AUClast of Filgotinib and Its Metabolite GS-82984
Hide Description AUClast is defined as the concentration of drug from time zero to the last observable concentration.
Time Frame Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Substudy Analysis Set with available data were analyzed.
Arm/Group Title Induction Study (Cohort A): Filgotinib 200 mg Induction Study (Cohort A): Filgotinib 100 mg Induction Study (Cohort B): Filgotinib 200 mg Induction Study (Cohort B): Filgotinib 100 mg
Hide Arm/Group Description:
Participants in Cohort A (biologic-naive) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
Overall Number of Participants Analyzed 4 11 9 17
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
Filgotinib Number Analyzed 4 participants 10 participants 9 participants 17 participants
5537.3  (1900.93) 1881.9  (797.51) 6743.1  (1743.68) 2420.3  (837.26)
Metabolite GS-829845 Number Analyzed 4 participants 11 participants 9 participants 17 participants
60938.4  (6961.77) 30643.2  (12935.37) 79286.3  (27968.49) 34385.6  (15160.15)
11.Secondary Outcome
Title Induction Study: PK Parameter: Ctau of Filgotinib and Its Metabolite GS-82984
Hide Description Ctau is defined as the observed drug concentration at the end of the dosing interval.
Time Frame Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Substudy Analysis Set with available data were analyzed.
Arm/Group Title Induction Study (Cohort A): Filgotinib 200 mg Induction Study (Cohort A): Filgotinib 100 mg Induction Study (Cohort B): Filgotinib 200 mg Induction Study (Cohort B): Filgotinib 100 mg
Hide Arm/Group Description:
Participants in Cohort A (biologic-naive) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
Overall Number of Participants Analyzed 4 11 9 17
Mean (Standard Deviation)
Unit of Measure: ng/mL
Filgotinib Number Analyzed 3 participants 8 participants 8 participants 13 participants
12.0  (4.74) 4.5  (3.61) 36.6  (79.06) 4.1  (3.05)
Metabolite GS-829845 Number Analyzed 3 participants 10 participants 8 participants 15 participants
2050.0  (493.66) 934.8  (372.68) 2581.3  (777.07) 1062.8  (463.67)
12.Secondary Outcome
Title Maintenance Study: Percentage of Participants Who Achieved MCS Remission at Week 58
Hide Description MCS remission was defined as having a MCS of 2 or less and no single subscore higher than 1. The MCS was composed of subscores from endoscopy (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease [spontaneous bleeding, ulceration]), rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), and PGA. The PGA acknowledged the participant's daily recollection of abdominal discomfort and general sense of wellbeing, and other observations, such as physical findings and the participant's performance status. The PGA score ranged from 0 to 3 with higher score indicating the severe disease. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating more severe disease.
Time Frame Week 58
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set for the Maintenance Study were analyzed.
Arm/Group Title Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg Maintenance Study: Placebo From Induction Filgotinib 200 mg Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg Maintenance Study: Placebo From Induction Filgotinib 100 mg
Hide Arm/Group Description:
Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for an additional 47 weeks (up to Week 58).
Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
Participants in the Filgotinib 100 mg arm) who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for an additional 47 weeks (up to Week 58).
Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were rerandomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
Overall Number of Participants Analyzed 199 98 172 89
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
34.7
(27.8 to 41.5)
9.2
(3.0 to 15.4)
22.7
(16.1 to 29.2)
13.5
(5.8 to 21.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg, Maintenance Study: Placebo From Induction Filgotinib 200 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 25.5
Confidence Interval (2-Sided) 95%
16.0 to 35.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg, Maintenance Study: Placebo From Induction Filgotinib 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0658
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 9.2
Confidence Interval (2-Sided) 95%
-1.1 to 19.5
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Maintenance Study: Percentage of Participants Who Achieved Sustained EBS Remission at Week 58
Hide Description Sustained EBS remission was defined as having achieved EBS remission at both Weeks 10 and 58.
Time Frame Week 58
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set for the Maintenance Study were analyzed.
Arm/Group Title Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg Maintenance Study: Placebo From Induction Filgotinib 200 mg Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg Maintenance Study: Placebo From Induction Filgotinib 100 mg
Hide Arm/Group Description:
Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for an additional 47 weeks (up to Week 58).
Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for an additional 47 weeks (up to Week 58).
Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were rerandomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
Overall Number of Participants Analyzed 199 98 172 89
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
18.1
(12.5 to 23.7)
5.1
(0.2 to 10.0)
8.7
(4.2 to 13.2)
7.9
(1.7 to 14.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg, Maintenance Study: Placebo From Induction Filgotinib 200 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0024
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 13.0
Confidence Interval (2-Sided) 95%
5.3 to 20.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg, Maintenance Study: Placebo From Induction Filgotinib 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7951
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
-7.0 to 8.7
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Maintenance Study: Percentage of Participants Who Achieved 6-Month Corticosteroid-Free EBS Remission at Week 58
Hide Description Six-month corticosteroid-free EBS remission at Week 58 was defined as achieving EBS remission with no corticosteroid use for the indication of ulcerative colitis for at least 6 months prior to Week 58.
Time Frame Week 58
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set who were on corticosteroids at Maintenance Study baseline were analyzed.
Arm/Group Title Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg Maintenance Study: Placebo From Induction Filgotinib 200 mg Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg Maintenance Study: Placebo From Induction Filgotinib 100 mg
Hide Arm/Group Description:
Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for an additional 47 weeks (up to Week 58).
Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for an additional 47 weeks (up to Week 58).
Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were rerandomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
Overall Number of Participants Analyzed 92 47 81 37
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
27.2
(17.5 to 36.8)
6.4
(0.0 to 14.4)
13.6
(5.5 to 21.7)
5.4
(0.0 to 14.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg, Maintenance Study: Placebo From Induction Filgotinib 200 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0055
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 20.8
Confidence Interval (2-Sided) 95%
7.7 to 33.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg, Maintenance Study: Placebo From Induction Filgotinib 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1265
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 8.2
Confidence Interval (2-Sided) 95%
-4.2 to 20.6
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Maintenance Study: Percentage of Participants Who Achieved Endoscopic Subscore of 0 at Weeks 58
Hide Description Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration).
Time Frame Week 58
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set for the Maintenance Study were analyzed.
Arm/Group Title Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg Maintenance Study: Placebo From Induction Filgotinib 200 mg Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg Maintenance Study: Placebo From Induction Filgotinib 100 mg
Hide Arm/Group Description:
Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for an additional 47 weeks (up to Week 58).
Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for an additional 47 weeks (up to Week 58).
Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were rerandomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
Overall Number of Participants Analyzed 199 98 172 89
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
15.6
(10.3 to 20.9)
6.1
(0.9 to 11.4)
13.4
(8.0 to 18.7)
7.9
(1.7 to 14.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg, Maintenance Study: Placebo From Induction Filgotinib 200 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0157
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 9.5
Confidence Interval (2-Sided) 95%
1.8 to 17.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg, Maintenance Study: Placebo From Induction Filgotinib 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1808
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 5.5
Confidence Interval (2-Sided) 95%
-2.9 to 13.9
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Maintenance Study: Percentage of Participants Who Achieved Geboes Histologic Remission at Week 58
Hide Description Geboes histologic remission was assessed using the Geboes histologic scores for evaluation of disease severity in ulcerative colitis and classifies histologic changes. Remission was defined as having Grade 0 of <= 0.3, Grade 1 of <= 1.1, Grade 2A of <= 2A.3, Grade 2B of 2B.0, Grade 3 of 3.0, Grade 4 of 4.0, and Grade 5 of 5.0. Possible scores are Grade 0: Architectural changes (0.0=No abnormality to 0.3=Severe diffuse or multifocal abnormalities); Grade 1: Chronic inflammatory infiltrate (1.0=No increase to 1.3=Marked increase); Grade 2A: Eosinophils in lamina propria (2A.0=No increase to 2A.3-=Marked increase; Grade 2B: Neutrophils in lamina propria (2B.0= No increase to 2B.3=Marked increase); Grade 3: Neutrophils in epithelium (3.0=None to 3.3=>50% crypts involved); Grade 4: Crypt destruction (4.0=none to 4.3=Unequivocal crypt destruction), and Grade 5: Erosions and ulcerations: (5.0=No erosion, ulceration or granulation to 5.4=Ulcer or granulation tissue).
Time Frame Week 58
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set for the Maintenance Study were analyzed.
Arm/Group Title Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg Maintenance Study: Placebo From Induction Filgotinib 200 mg Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg Maintenance Study: Placebo From Induction Filgotinib 100 mg
Hide Arm/Group Description:
Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for an additional 47 weeks (up to Week 58).
Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for an additional 47 weeks (up to Week 58).
Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were rerandomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
Overall Number of Participants Analyzed 199 98 172 89
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
38.2
(31.2 to 45.2)
13.3
(6.0 to 20.5)
27.9
(20.9 to 34.9)
18.0
(9.4 to 26.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg, Maintenance Study: Placebo From Induction Filgotinib 200 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 24.9
Confidence Interval (2-Sided) 95%
14.6 to 35.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg, Maintenance Study: Placebo From Induction Filgotinib 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0521
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 9.9
Confidence Interval (2-Sided) 95%
-1.3 to 21.2
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Maintenance Study: Percentage of Participants Who Achieved MCS Remission (Alternative Definition) at Week 58
Hide Description MCS remission (alternative definition) was defined as having rectal bleeding, stool frequency, and PGA subscores of 0 and an endoscopic subscore of 0 or 1; overall MCS of ≤ 1. MCS possible subscores: rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), PGA subscore (range: 0 to 3 with higher score indicating the severe disease), and an endoscopic subscore (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease [spontaneous bleeding, ulceration]. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating more severe disease.
Time Frame Week 58
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set for the Maintenance Study were analyzed.
Arm/Group Title Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg Maintenance Study: Placebo From Induction Filgotinib 200 mg Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg Maintenance Study: Placebo From Induction Filgotinib 100 mg
Hide Arm/Group Description:
Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for an additional 47 weeks (up to Week 58).
Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for an additional 47 weeks (up to Week 58).
Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were rerandomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
Overall Number of Participants Analyzed 199 98 172 89
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
22.1
(16.1 to 28.1)
6.1
(0.9 to 11.4)
12.2
(7.0 to 17.4)
7.9
(1.7 to 14.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg, Maintenance Study: Placebo From Induction Filgotinib 200 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 16.0
Confidence Interval (2-Sided) 95%
7.8 to 24.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg, Maintenance Study: Placebo From Induction Filgotinib 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2946
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments CMH test was stratified by concomitant use of corticosteroids and of immunomodulators at maintenance baseline; participation in Induction (A or B).
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 4.3
Confidence Interval (2-Sided) 95%
-3.9 to 12.6
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Maintenance Study: Plasma Concentration of Filgotinib and Its Metabolite GS-829845
Hide Description Plasma concentration is defined as the measured drug concentration of filgotinib and its metabolite GS-829845. Lower limit of quantitation (LLOQ) was defined as 1 ng/mL for analyte filgotinib and 2 ng/mL for analyte GS-829845.
Time Frame Week 26 (any Time) and Week 58 (predose)
Hide Outcome Measure Data
Hide Analysis Population Description
PK Analysis Set included all participants in the Safety Analysis Set who who took at least 1 dose of filgotinib and had at least 1 nonmissing plasma concentration value for filgotinib and/or its metabolite GS-829845 with available data were analyzed. Data was not collected for the Maintenance Study Placebo arms.
Arm/Group Title Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg
Hide Arm/Group Description:
Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for an additional 47 weeks (up to Week 58).
Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for an additional 47 weeks (up to Week 58).
Overall Number of Participants Analyzed 173 136
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
Filgotinib: Week 26 Number Analyzed 169 participants 127 participants
8.5
(5.0 to 25.8)
4.4
(2.5 to 14.0)
Filgotinib: Week 58 Number Analyzed 44 participants 26 participants
3.9 [1] 
(NA to 9.1)
4.1 [1] 
(NA to 6.9)
Metabolite GS-829845: Week 26 Number Analyzed 170 participants 130 participants
2495.0
(1940.0 to 3010.0)
1180.0
(852.0 to 1550.0)
Metabolite GS-829845: Week 58 Number Analyzed 44 participants 26 participants
1930.0
(1320.0 to 2630.0)
973.5
(773.0 to 1350.0)
[1]
Value was below the limit of quantitation.
Time Frame Induction Study: first dose date up to one day before the Maintenance first dose date or last dose date whichever is earlier (maximum 17 weeks) plus 30 days, Maintenance study: First dose to the last dose in the Maintenance Study (maximum 51 weeks) plus 30 days
Adverse Event Reporting Description Adverse Events: Safety Analysis Set for the study included all participants who took at least 1 dose of study drug in either the Induction Study (Cohorts A and B) or the Maintenance Study. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized on Day 1 into each corresponding study.
 
Arm/Group Title Induction Study (Cohort A): Filgotinib 200 mg Induction Study (Cohort A): Filgotinib 100 mg Induction Study (Cohort A): Placebo Induction Study (Cohort B): Filgotinib 200 mg Induction Study (Cohort B): Filgotinib 100 mg Induction Study (Cohort B): Placebo Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg Maintenance Study: Placebo From Induction Filgotinib 200 mg Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg Maintenance Study: Placebo From Induction Filgotinib 100 mg Maintenance Study: Placebo From Induction Placebo
Hide Arm/Group Description Participants in Cohort A (biologic-naive) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks. Participants in Cohort A (biologic-naive) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks. Participants in Cohort B (biologic-experienced) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for an additional 47 weeks (up to Week 58). Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58). Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for an additional 47 weeks (up to Week 58). Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were rerandomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58). Participants in the Placebo arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
All-Cause Mortality
Induction Study (Cohort A): Filgotinib 200 mg Induction Study (Cohort A): Filgotinib 100 mg Induction Study (Cohort A): Placebo Induction Study (Cohort B): Filgotinib 200 mg Induction Study (Cohort B): Filgotinib 100 mg Induction Study (Cohort B): Placebo Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg Maintenance Study: Placebo From Induction Filgotinib 200 mg Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg Maintenance Study: Placebo From Induction Filgotinib 100 mg Maintenance Study: Placebo From Induction Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/245 (0.00%)   0/278 (0.00%)   0/137 (0.00%)   0/262 (0.00%)   0/286 (0.00%)   0/143 (0.00%)   2/202 (0.99%)   0/99 (0.00%)   0/179 (0.00%)   0/91 (0.00%)   0/93 (0.00%) 
Hide Serious Adverse Events
Induction Study (Cohort A): Filgotinib 200 mg Induction Study (Cohort A): Filgotinib 100 mg Induction Study (Cohort A): Placebo Induction Study (Cohort B): Filgotinib 200 mg Induction Study (Cohort B): Filgotinib 100 mg Induction Study (Cohort B): Placebo Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg Maintenance Study: Placebo From Induction Filgotinib 200 mg Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg Maintenance Study: Placebo From Induction Filgotinib 100 mg Maintenance Study: Placebo From Induction Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/245 (1.22%)   13/277 (4.69%)   4/137 (2.92%)   19/262 (7.25%)   15/285 (5.26%)   9/142 (6.34%)   9/202 (4.46%)   0/99 (0.00%)   8/179 (4.47%)   7/91 (7.69%)   4/93 (4.30%) 
Blood and lymphatic system disorders                       
Anaemia  1  0/245 (0.00%)  1/277 (0.36%)  1/137 (0.73%)  1/262 (0.38%)  1/285 (0.35%)  0/142 (0.00%)  0/202 (0.00%)  0/99 (0.00%)  0/179 (0.00%)  0/91 (0.00%)  0/93 (0.00%) 
Iron deficiency anaemia  1  0/245 (0.00%)  1/277 (0.36%)  0/137 (0.00%)  1/262 (0.38%)  0/285 (0.00%)  0/142 (0.00%)  0/202 (0.00%)  0/99 (0.00%)  0/179 (0.00%)  1/91 (1.10%)  0/93 (0.00%) 
Pancytopenia  1  0/245 (0.00%)  1/277 (0.36%)  0/137 (0.00%)  0/262 (0.00%)  0/285 (0.00%)  0/142 (0.00%)  0/202 (0.00%)  0/99 (0.00%)  0/179 (0.00%)  0/91 (0.00%)  0/93 (0.00%) 
Cardiac disorders                       
Coronary artery stenosis  1  0/245 (0.00%)  0/277 (0.00%)  0/137 (0.00%)  0/262 (0.00%)  0/285 (0.00%)  0/142 (0.00%)  0/202 (0.00%)  0/99 (0.00%)  0/179 (0.00%)  1/91 (1.10%)  0/93 (0.00%) 
Left ventricular failure  1  0/245 (0.00%)  0/277 (0.00%)  0/137 (0.00%)  0/262 (0.00%)  0/285 (0.00%)  0/142 (0.00%)  1/202 (0.50%)  0/99 (0.00%)  0/179 (0.00%)  0/91 (0.00%)  0/93 (0.00%) 
Pericarditis  1  1/245 (0.41%)  0/277 (0.00%)  0/137 (0.00%)  0/262 (0.00%)  0/285 (0.00%)  0/142 (0.00%)  0/202 (0.00%)  0/99 (0.00%)  0/179 (0.00%)  0/91 (0.00%)  0/93 (0.00%) 
Gastrointestinal disorders                       
Abdominal pain  1  0/245 (0.00%)  0/277 (0.00%)  0/137 (0.00%)  1/262 (0.38%)  0/285 (0.00%)  0/142 (0.00%)  0/202 (0.00%)  0/99 (0.00%)  1/179 (0.56%)  0/91 (0.00%)  0/93 (0.00%) 
Anal fissure  1  0/245 (0.00%)  0/277 (0.00%)  0/137 (0.00%)  1/262 (0.38%)  0/285 (0.00%)  0/142 (0.00%)  0/202 (0.00%)  0/99 (0.00%)  0/179 (0.00%)  0/91 (0.00%)  0/93 (0.00%) 
Appendiceal mucocoele  1  0/245 (0.00%)  0/277 (0.00%)  0/137 (0.00%)  1/262 (0.38%)  0/285 (0.00%)  0/142 (0.00%)  0/202 (0.00%)  0/99 (0.00%)  0/179 (0.00%)  0/91 (0.00%)  0/93 (0.00%) 
Colitis ulcerative  1  0/245 (0.00%)  3/277 (1.08%)  3/137 (2.19%)  7/262 (2.67%)  5/285 (1.75%)  5/142 (3.52%)  0/202 (0.00%)  0/99 (0.00%)  1/179 (0.56%)  1/91 (1.10%)  0/93 (0.00%) 
Dental cyst  1  0/245 (0.00%)  0/277 (0.00%)  0/137 (0.00%)  0/262 (0.00%)  0/285 (0.00%)  0/142 (0.00%)  0/202 (0.00%)  0/99 (0.00%)  0/179 (0.00%)  0/91 (0.00%)  1/93 (1.08%) 
Duodenal ulcer haemorrhage  1  0/245 (0.00%)  0/277 (0.00%)  0/137 (0.00%)  1/262 (0.38%)  0/285 (0.00%)  0/142 (0.00%)  0/202 (0.00%)  0/99 (0.00%)  0/179 (0.00%)  0/91 (0.00%)  0/93 (0.00%) 
Gastritis  1  0/245 (0.00%)  0/277 (0.00%)  0/137 (0.00%)  0/262 (0.00%)  1/285 (0.35%)  0/142 (0.00%)  0/202 (0.00%)  0/99 (0.00%)  0/179 (0.00%)  0/91 (0.00%)  0/93 (0.00%) 
Gastrointestinal haemorrhage  1  1/245 (0.41%)  0/277 (0.00%)  0/137 (0.00%)  0/262 (0.00%)  0/285 (0.00%)  0/142 (0.00%)  0/202 (0.00%)  0/99 (0.00%)  0/179 (0.00%)  0/91 (0.00%)  0/93 (0.00%) 
Large intestinal haemorrhage  1  0/245 (0.00%)  0/277 (0.00%)  0/137 (0.00%)  1/262 (0.38%)  0/285 (0.00%)  0/142 (0.00%)  0/202 (0.00%)  0/99 (0.00%)  0/179 (0.00%)  0/91 (0.00%)  0/93 (0.00%) 
Nausea  1  0/245 (0.00%)  0/277 (0.00%)  0/137 (0.00%)  0/262 (0.00%)  1/285 (0.35%)  0/142 (0.00%)  0/202 (0.00%)  0/99 (0.00%)  0/179 (0.00%)  0/91 (0.00%)  0/93 (0.00%) 
Pancreatitis acute  1  0/245 (0.00%)  0/277 (0.00%)  0/137 (0.00%)  0/262 (0.00%)  0/285 (0.00%)  1/142 (0.70%)  0/202 (0.00%)  0/99 (0.00%)  1/179 (0.56%)  0/91 (0.00%)  0/93 (0.00%) 
Supernumerary teeth  1  0/245 (0.00%)  0/277 (0.00%)  0/137 (0.00%)  0/262 (0.00%)  0/285 (0.00%)  0/142 (0.00%)  0/202 (0.00%)  0/99 (0.00%)  0/179 (0.00%)  0/91 (0.00%)  1/93 (1.08%) 
Vomiting  1  0/245 (0.00%)  1/277 (0.36%)  0/137 (0.00%)  0/262 (0.00%)  1/285 (0.35%)  0/142 (0.00%)  0/202 (0.00%)  0/99 (0.00%)  0/179 (0.00%)  0/91 (0.00%)  0/93 (0.00%) 
General disorders                       
Chest pain  1  0/245 (0.00%)  0/277 (0.00%)  0/137 (0.00%)  0/262 (0.00%)  1/285 (0.35%)  0/142 (0.00%)  1/202 (0.50%)  0/99 (0.00%)  0/179 (0.00%)  0/91 (0.00%)  0/93 (0.00%) 
Non-cardiac chest pain  1  0/245 (0.00%)  0/277 (0.00%)  0/137 (0.00%)  0/262 (0.00%)  0/285 (0.00%)  0/142 (0.00%)  0/202 (0.00%)  0/99 (0.00%)  1/179 (0.56%)  0/91 (0.00%)  0/93 (0.00%) 
Pyrexia  1  0/245 (0.00%)  0/277 (0.00%)  0/137 (0.00%)  0/262 (0.00%)  0/285 (0.00%)  0/142 (0.00%)  1/202 (0.50%)  0/99 (0.00%)  1/179 (0.56%)  0/91 (0.00%)  0/93 (0.00%) 
Hepatobiliary disorders                       
Autoimmune hepatitis  1  0/245 (0.00%)  0/277 (0.00%)  0/137 (0.00%)  0/262 (0.00%)  0/285 (0.00%)  0/142 (0.00%)  0/202 (0.00%)  0/99 (0.00%)  0/179 (0.00%)  1/91 (1.10%)  0/93 (0.00%) 
Cholelithiasis  1  0/245 (0.00%)  0/277 (0.00%)  0/137 (0.00%)  0/262 (0.00%)  0/285 (0.00%)  0/142 (0.00%)  0/202 (0.00%)  0/99 (0.00%)  1/179 (0.56%)  0/91 (0.00%)  0/93 (0.00%) 
Immune system disorders                       
Type I hypersensitivity  1  0/245 (0.00%)  1/277 (0.36%)  0/137 (0.00%)  0/262 (0.00%)  0/285 (0.00%)  0/142 (0.00%)  0/202 (0.00%)  0/99 (0.00%)  0/179 (0.00%)  0/91 (0.00%)  0/93 (0.00%) 
Infections and infestations                       
Acute hepatitis B  1  0/245 (0.00%)  0/277 (0.00%)  0/137 (0.00%)  0/262 (0.00%)  0/285 (0.00%)  0/142 (0.00%)  0/202 (0.00%)  0/99 (0.00%)  0/179 (0.00%)  1/91 (1.10%)  0/93 (0.00%) 
Anal abscess  1  0/245 (0.00%)  0/277 (0.00%)  0/137 (0.00%)  0/262 (0.00%)  1/285 (0.35%)  0/142 (0.00%)  0/202 (0.00%)  0/99 (0.00%)  0/179 (0.00%)  0/91 (0.00%)  0/93 (0.00%) 
Appendicitis  1  0/245 (0.00%)  1/277 (0.36%)  0/137 (0.00%)  0/262 (0.00%)  0/285 (0.00%)  0/142 (0.00%)  1/202 (0.50%)  0/99 (0.00%)  2/179 (1.12%)  0/91 (0.00%)  0/93 (0.00%) 
Campylobacter gastroenteritis  1  0/245 (0.00%)  0/277 (0.00%)  0/137 (0.00%)  0/262 (0.00%)  0/285 (0.00%)  1/142 (0.70%)  0/202 (0.00%)  0/99 (0.00%)  0/179 (0.00%)  0/91 (0.00%)  0/93 (0.00%) 
Cellulitis  1  0/245 (0.00%)  0/277 (0.00%)  1/137 (0.73%)  0/262 (0.00%)  0/285 (0.00%)  0/142 (0.00%)  0/202 (0.00%)  0/99 (0.00%)  1/179 (0.56%)  0/91 (0.00%)  0/93 (0.00%) 
Clostridium difficile infection  1  0/245 (0.00%)  0/277 (0.00%)  0/137 (0.00%)  1/262 (0.38%)  0/285 (0.00%)  0/142 (0.00%)  0/202 (0.00%)  0/99 (0.00%)  0/179 (0.00%)  0/91 (0.00%)  0/93 (0.00%) 
Dengue fever  1  1/245 (0.41%)  0/277 (0.00%)  0/137 (0.00%)  0/262 (0.00%)  0/285 (0.00%)  0/142 (0.00%)  0/202 (0.00%)  0/99 (0.00%)  0/179 (0.00%)  0/91 (0.00%)  0/93 (0.00%) 
Diverticulitis  1  0/245 (0.00%)  0/277 (0.00%)  0/137 (0.00%)  0/262 (0.00%)  0/285 (0.00%)  0/142 (0.00%)  1/202 (0.50%)  0/99 (0.00%)  0/179 (0.00%)  0/91 (0.00%)  0/93 (0.00%) 
Gastroenteritis  1  0/245 (0.00%)  1/277 (0.36%)  0/137 (0.00%)  0/262 (0.00%)  0/285 (0.00%)  0/142 (0.00%)  0/202 (0.00%)  0/99 (0.00%)  0/179 (0.00%)  0/91 (0.00%)  0/93 (0.00%) 
Gastroenteritis viral  1  0/245 (0.00%)  0/277 (0.00%)  0/137 (0.00%)  1/262 (0.38%)  0/285 (0.00%)  1/142 (0.70%)  0/202 (0.00%)  0/99 (0.00%)  0/179 (0.00%)  1/91 (1.10%)  0/93 (0.00%) 
Osteomyelitis  1  0/245 (0.00%)  0/277 (0.00%)  1/137 (0.73%)  0/262 (0.00%)  0/285 (0.00%)  0/142 (0.00%)  0/202 (0.00%)  0/99 (0.00%)  0/179 (0.00%)  0/91 (0.00%)  0/93 (0.00%) 
Paronychia  1  0/245 (0.00%)  0/277 (0.00%)  0/137 (0.00%)  0/262 (0.00%)  0/285 (0.00%)  0/142 (0.00%)  0/202 (0.00%)  0/99 (0.00%)  1/179 (0.56%)  0/91 (0.00%)  0/93 (0.00%) 
Pneumonia  1  0/245 (0.00%)  0/277 (0.00%)  0/137 (0.00%)  0/262 (0.00%)  0/285 (0.00%)  0/142 (0.00%)  0/202 (0.00%)  0/99 (0.00%)  0/179 (0.00%)  0/91 (0.00%)  1/93 (1.08%) 
Sepsis  1  0/245 (0.00%)  0/277 (0.00%)  0/137 (0.00%)  0/262 (0.00%)  2/285 (0.70%)  0/142 (0.00%)  0/202 (0.00%)  0/99 (0.00%)  0/179 (0.00%)  0/91 (0.00%)  0/93 (0.00%) 
Staphylococcal infection  1  0/245 (0.00%)  0/277 (0.00%)  0/137 (0.00%)  0/262 (0.00%)  1/285 (0.35%)  0/142 (0.00%)  0/202 (0.00%)  0/99 (0.00%)  0/179 (0.00%)  0/91 (0.00%)  0/93 (0.00%) 
Injury, poisoning and procedural complications                       
Femur fracture  1  0/245 (0.00%)  0/277 (0.00%)  0/137 (0.00%)  0/262 (0.00%)  1/285 (0.35%)  0/142 (0.00%)  0/202 (0.00%)  0/99 (0.00%)  0/179 (0.00%)  0/91 (0.00%)  0/93 (0.00%) 
Meniscus injury  1  0/245 (0.00%)  0/277 (0.00%)  0/137 (0.00%)  0/262 (0.00%)  0/285 (0.00%)  0/142 (0.00%)  0/202 (0.00%)  0/99 (0.00%)  0/179 (0.00%)  1/91 (1.10%)  0/93 (0.00%) 
Procedural intestinal perforation  1  0/245 (0.00%)  0/277 (0.00%)  1/137 (0.73%)  0/262 (0.00%)  0/285 (0.00%)  0/142 (0.00%)  0/202 (0.00%)  0/99 (0.00%)  0/179 (0.00%)  0/91 (0.00%)  0/93 (0.00%) 
Road traffic accident  1  0/245 (0.00%)  1/277 (0.36%)  0/137 (0.00%)  0/262 (0.00%)  0/285 (0.00%)  0/142 (0.00%)  0/202 (0.00%)  0/99 (0.00%)  0/179 (0.00%)  0/91 (0.00%)  0/93 (0.00%) 
Tendon rupture  1  0/245 (0.00%)  0/277 (0.00%)  0/137 (0.00%)  0/262 (0.00%)  0/285 (0.00%)  0/142 (0.00%)  1/202 (0.50%)  0/99 (0.00%)  0/179 (0.00%)  0/91 (0.00%)  0/93 (0.00%) 
Musculoskeletal and connective tissue disorders                       
Intervertebral disc protrusion  1  0/245 (0.00%)  0/277 (0.00%)  0/137 (0.00%)  2/262 (0.76%)  0/285 (0.00%)  0/142 (0.00%)  0/202 (0.00%)  0/99 (0.00%)  0/179 (0.00%)  0/91 (0.00%)  0/93 (0.00%) 
Myalgia  1  0/245 (0.00%)  0/277 (0.00%)  0/137 (0.00%)  0/262 (0.00%)  1/285 (0.35%)  0/142 (0.00%)  0/202 (0.00%)  0/99 (0.00%)  0/179 (0.00%)  0/91 (0.00%)  0/93 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                       
Breast cancer  1  0/245 (0.00%)  0/277 (0.00%)  0/137 (0.00%)  1/262 (0.38%)  0/285 (0.00%)  0/142 (0.00%)  0/202 (0.00%)  0/99 (0.00%)  0/179 (0.00%)  0/91 (0.00%)  0/93 (0.00%) 
Colon cancer  1  0/245 (0.00%)  0/277 (0.00%)  0/137 (0.00%)  0/262 (0.00%)  0/285 (0.00%)  0/142 (0.00%)  0/202 (0.00%)  0/99 (0.00%)  1/179 (0.56%)  0/91 (0.00%)  0/93 (0.00%) 
Malignant melanoma  1  0/245 (0.00%)  0/277 (0.00%)  0/137 (0.00%)  0/262 (0.00%)  0/285 (0.00%)  0/142 (0.00%)  1/202 (0.50%)  0/99 (0.00%)  0/179 (0.00%)  0/91 (0.00%)  0/93 (0.00%) 
Nervous system disorders                       
Cerebrovascular accident  1  0/245 (0.00%)  0/277 (0.00%)  0/137 (0.00%)  0/262 (0.00%)  0/285 (0.00%)  1/142 (0.70%)  0/202 (0.00%)  0/99 (0.00%)  0/179 (0.00%)  0/91 (0.00%)  0/93 (0.00%) 
Headache  1  0/245 (0.00%)  0/277 (0.00%)  0/137 (0.00%)  0/262 (0.00%)  1/285 (0.35%)  0/142 (0.00%)  0/202 (0.00%)  0/99 (0.00%)  0/179 (0.00%)  0/91 (0.00%)  0/93 (0.00%) 
Transient ischaemic attack  1  0/245 (0.00%)  0/277 (0.00%)  0/137 (0.00%)  0/262 (0.00%)  0/285 (0.00%)  0/142 (0.00%)  0/202 (0.00%)  0/99 (0.00%)  1/179 (0.56%)  0/91 (0.00%)  0/93 (0.00%) 
Pregnancy, puerperium and perinatal conditions                       
Ectopic pregnancy  1  0/245 (0.00%)  0/277 (0.00%)  0/137 (0.00%)  0/262 (0.00%)  1/285 (0.35%)  0/142 (0.00%)  0/202 (0.00%)  0/99 (0.00%)  0/179 (0.00%)  0/91 (0.00%)  0/93 (0.00%) 
Renal and urinary disorders                       
Acute kidney injury  1  0/245 (0.00%)  0/277 (0.00%)  0/137 (0.00%)  0/262 (0.00%)  0/285 (0.00%)  0/142 (0.00%)  0/202 (0.00%)  0/99 (0.00%)  0/179 (0.00%)  0/91 (0.00%)  1/93 (1.08%) 
Calculus urinary  1  0/245 (0.00%)  0/277 (0.00%)  0/137 (0.00%)  0/262 (0.00%)  0/285 (0.00%)  0/142 (0.00%)  1/202 (0.50%)  0/99 (0.00%)  0/179 (0.00%)  0/91 (0.00%)  0/93 (0.00%) 
Nephrolithiasis  1  0/245 (0.00%)  0/277 (0.00%)  0/137 (0.00%)  1/262 (0.38%)  0/285 (0.00%)  0/142 (0.00%)  0/202 (0.00%)  0/99 (0.00%)  0/179 (0.00%)  0/91 (0.00%)  0/93 (0.00%) 
Renal colic  1  0/245 (0.00%)  0/277 (0.00%)  0/137 (0.00%)  0/262 (0.00%)  0/285 (0.00%)  1/142 (0.70%)  0/202 (0.00%)  0/99 (0.00%)  0/179 (0.00%)  0/91 (0.00%)  0/93 (0.00%) 
Reproductive system and breast disorders                       
Ovarian cyst ruptured  1  0/245 (0.00%)  1/277 (0.36%)  0/137 (0.00%)  0/262 (0.00%)  0/285 (0.00%)  0/142 (0.00%)  0/202 (0.00%)  0/99 (0.00%)  0/179 (0.00%)  0/91 (0.00%)  0/93 (0.00%) 
Respiratory, thoracic and mediastinal disorders                       
Asthma  1  0/245 (0.00%)  0/277 (0.00%)  0/137 (0.00%)  0/262 (0.00%)  0/285 (0.00%)  0/142 (0.00%)  1/202 (0.50%)  0/99 (0.00%)  0/179 (0.00%)  0/91 (0.00%)  0/93 (0.00%) 
Atelectasis  1  0/245 (0.00%)  0/277 (0.00%)  0/137 (0.00%)  0/262 (0.00%)  0/285 (0.00%)  0/142 (0.00%)  0/202 (0.00%)  0/99 (0.00%)  1/179 (0.56%)  0/91 (0.00%)  0/93 (0.00%) 
Dyspnoea  1  0/245 (0.00%)  0/277 (0.00%)  0/137 (0.00%)  0/262 (0.00%)  0/285 (0.00%)  0/142 (0.00%)  0/202 (0.00%)  0/99 (0.00%)  1/179 (0.56%)  0/91 (0.00%)  0/93 (0.00%) 
Haemoptysis  1  0/245 (0.00%)  0/277 (0.00%)  0/137 (0.00%)  0/262 (0.00%)  0/285 (0.00%)  1/142 (0.70%)  0/202 (0.00%)  0/99 (0.00%)  0/179 (0.00%)  0/91 (0.00%)  0/93 (0.00%) 
Pulmonary embolism  1  0/245 (0.00%)  0/277 (0.00%)  0/137 (0.00%)  1/262 (0.38%)  0/285 (0.00%)  0/142 (0.00%)  0/202 (0.00%)  0/99 (0.00%)  0/179 (0.00%)  0/91 (0.00%)  0/93 (0.00%) 
Pulmonary mass  1  0/245 (0.00%)  0/277 (0.00%)  0/137 (0.00%)  0/262 (0.00%)  0/285 (0.00%)  0/142 (0.00%)  0/202 (0.00%)  0/99 (0.00%)  1/179 (0.56%)  0/91 (0.00%)  0/93 (0.00%) 
Vascular disorders                       
Deep vein thrombosis  1  0/245 (0.00%)  0/277 (0.00%)  0/137 (0.00%)  0/262 (0.00%)  0/285 (0.00%)  0/142 (0.00%)  0/202 (0.00%)  0/99 (0.00%)  0/179 (0.00%)  0/91 (0.00%)  1/93 (1.08%) 
Haemorrhagic infarction  1  0/245 (0.00%)  0/277 (0.00%)  0/137 (0.00%)  0/262 (0.00%)  0/285 (0.00%)  0/142 (0.00%)  0/202 (0.00%)  0/99 (0.00%)  0/179 (0.00%)  0/91 (0.00%)  1/93 (1.08%) 
Hypertension  1  0/245 (0.00%)  1/277 (0.36%)  0/137 (0.00%)  0/262 (0.00%)  0/285 (0.00%)  0/142 (0.00%)  0/202 (0.00%)  0/99 (0.00%)  0/179 (0.00%)  0/91 (0.00%)  0/93 (0.00%) 
1
Term from vocabulary, MedDRA 22.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Induction Study (Cohort A): Filgotinib 200 mg Induction Study (Cohort A): Filgotinib 100 mg Induction Study (Cohort A): Placebo Induction Study (Cohort B): Filgotinib 200 mg Induction Study (Cohort B): Filgotinib 100 mg Induction Study (Cohort B): Placebo Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg Maintenance Study: Placebo From Induction Filgotinib 200 mg Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg Maintenance Study: Placebo From Induction Filgotinib 100 mg Maintenance Study: Placebo From Induction Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   40/245 (16.33%)   43/277 (15.52%)   20/137 (14.60%)   83/262 (31.68%)   77/285 (27.02%)   55/142 (38.73%)   67/202 (33.17%)   33/99 (33.33%)   53/179 (29.61%)   33/91 (36.26%)   26/93 (27.96%) 
Blood and lymphatic system disorders                       
Anaemia  1  6/245 (2.45%)  10/277 (3.61%)  4/137 (2.92%)  12/262 (4.58%)  11/285 (3.86%)  10/142 (7.04%)  4/202 (1.98%)  0/99 (0.00%)  4/179 (2.23%)  1/91 (1.10%)  0/93 (0.00%) 
Gastrointestinal disorders                       
Abdominal pain  1  3/245 (1.22%)  3/277 (1.08%)  3/137 (2.19%)  8/262 (3.05%)  7/285 (2.46%)  9/142 (6.34%)  8/202 (3.96%)  6/99 (6.06%)  6/179 (3.35%)  2/91 (2.20%)  4/93 (4.30%) 
Colitis ulcerative  1  6/245 (2.45%)  3/277 (1.08%)  5/137 (3.65%)  14/262 (5.34%)  11/285 (3.86%)  6/142 (4.23%)  21/202 (10.40%)  18/99 (18.18%)  18/179 (10.06%)  16/91 (17.58%)  10/93 (10.75%) 
Nausea  1  8/245 (3.27%)  3/277 (1.08%)  1/137 (0.73%)  7/262 (2.67%)  15/285 (5.26%)  6/142 (4.23%)  5/202 (2.48%)  1/99 (1.01%)  4/179 (2.23%)  0/91 (0.00%)  2/93 (2.15%) 
General disorders                       
Pyrexia  1  5/245 (2.04%)  1/277 (0.36%)  1/137 (0.73%)  6/262 (2.29%)  3/285 (1.05%)  8/142 (5.63%)  6/202 (2.97%)  1/99 (1.01%)  4/179 (2.23%)  3/91 (3.30%)  1/93 (1.08%) 
Infections and infestations                       
Nasopharyngitis  1  7/245 (2.86%)  9/277 (3.25%)  2/137 (1.46%)  20/262 (7.63%)  20/285 (7.02%)  11/142 (7.75%)  22/202 (10.89%)  6/99 (6.06%)  12/179 (6.70%)  6/91 (6.59%)  5/93 (5.38%) 
Upper respiratory tract infection  1  2/245 (0.82%)  2/277 (0.72%)  0/137 (0.00%)  13/262 (4.96%)  4/285 (1.40%)  5/142 (3.52%)  11/202 (5.45%)  3/99 (3.03%)  6/179 (3.35%)  3/91 (3.30%)  3/93 (3.23%) 
Musculoskeletal and connective tissue disorders                       
Arthralgia  1  0/245 (0.00%)  4/277 (1.44%)  2/137 (1.46%)  8/262 (3.05%)  10/285 (3.51%)  7/142 (4.93%)  8/202 (3.96%)  7/99 (7.07%)  6/179 (3.35%)  3/91 (3.30%)  4/93 (4.30%) 
Nervous system disorders                       
Headache  1  11/245 (4.49%)  12/277 (4.33%)  6/137 (4.38%)  19/262 (7.25%)  10/285 (3.51%)  9/142 (6.34%)  7/202 (3.47%)  0/99 (0.00%)  10/179 (5.59%)  5/91 (5.49%)  5/93 (5.38%) 
1
Term from vocabulary, MedDRA 22.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:

  • The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
  • The study has been completed at all study sites for at least 2 years
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gilead Clinical Study Information Center
Organization: Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
EMail: GileadClinicalTrials@gilead.com
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02914522    
Other Study ID Numbers: GS-US-418-3898
2016-001392-78 ( EudraCT Number )
First Submitted: September 22, 2016
First Posted: September 26, 2016
Results First Submitted: March 23, 2021
Results First Posted: April 21, 2021
Last Update Posted: April 21, 2021