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Study to Assess Safety and Efficacy of Filgotinib, Lanraplenib and Tirabrutinib in Adults With Active Sjogren's Syndrome

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ClinicalTrials.gov Identifier: NCT03100942
Recruitment Status : Completed
First Posted : April 4, 2017
Results First Posted : January 22, 2020
Last Update Posted : October 23, 2020
Sponsor:
Collaborators:
Galapagos NV
Ono Pharmaceutical Co. Ltd
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 Sjogren's Syndrome
Interventions Drug: Lanraplenib
Drug: Filgotinib
Drug: Tirabrutinib
Drug: Lanraplenib placebo
Drug: Filgotinib placebo
Drug: Tirabrutinib placebo
Enrollment 152
Recruitment Details Participants were enrolled at study sites in the United States and Europe. The first participant was screened on 01 May 2017. The last study visit occurred on 02 October 2019.
Pre-assignment Details 348 participants were screened.
Arm/Group Title Lanraplenib Filgotinib Tirabrutinib Placebo Placebo to Lanraplenib Placebo to Filgotinib Placebo to Tirabrutinib
Hide Arm/Group Description Lanraplenib (1 x 30 mg tablet) + filgotinib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet) orally once daily for up to 49.4 weeks. Filgotinib (1 x 200 mg tablet) + lanraplenib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet) orally once daily for up to 50.4 weeks Tirabrutinib (1 x 40 mg tablet) + filgotinib placebo (1 x tablet) + lanraplenib placebo (1 x tablet) orally once daily for up to 50.3 weeks

Participants received filgotinib placebo + lanraplenib placebo + tirabrutinib placebo tablets orally once daily for 24 weeks.

At Week 24 visit, participants were re-randomized 1:1:1, in a blinded fashion and receive either of the following study drugs through Week 48:

  • filgotinib + lanraplenib placebo + tirabrutinib placebo
  • lanraplenib + filgotinib placebo + tirabrutinib placebo
  • tirabrutinib + filgotinib placebo + lanraplenib placebo
Participants who received placebo for 24 weeks were re-randomized at the Week 24 visit and received lanraplenib (1 × 30 mg tablet) + filgotinib placebo (1 × tablet) + tirabrutinib placebo (1 × tablet) orally once daily for up to 25.1 weeks. Participants who received placebo for 24 weeks were re-randomized at the Week 24 visit and received filgotinib (1 × 200 mg tablet) + lanraplenib placebo (1 × tablet) + tirabrutinib placebo (1 × tablet) orally once daily for up to 24.4 weeks. Participants who received placebo for 24 weeks were re-randomized at the Week 24 visit and received tirabrutinib (1 × 40 mg tablet) + filgotinib placebo (1 × tablet) + lanraplenib placebo (1 × tablet) orally once daily for up to 24.9 weeks.
Period Title: Randomized Treatment Period
Started 38 38 39 37 0 0 0
Completed 26 29 33 32 0 0 0
Not Completed 12 9 6 5 0 0 0
Reason Not Completed
Withdrew Consent             4             5             3             3             0             0             0
Adverse Event             5             2             1             0             0             0             0
Investigator's Discretion             2             1             0             0             0             0             0
Protocol Violation             0             1             1             1             0             0             0
Lost to Follow-up             0             0             1             0             0             0             0
Randomized but Didn't Receive Study Drug             1             0             0             1             0             0             0
Period Title: Placebo Arm Re-Randomized
Started 0 0 0 0 10 12 10
Completed 0 0 0 0 10 12 9
Not Completed 0 0 0 0 0 0 1
Reason Not Completed
Withdrew Consent             0             0             0             0             0             0             1
Arm/Group Title Lanraplenib Filgotinib Tirabrutinib Placebo Total
Hide Arm/Group Description Lanraplenib (1 x 30 mg tablet) + filgotinib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet) orally once daily for up to 49.4 weeks. Filgotinib (1 x 200 mg tablet) + lanraplenib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet) orally once daily for up to 50.4 weeks. Tirabrutinib (1 x 40 mg tablet) + filgotinib placebo (1 x tablet) + lanraplenib placebo (1 x tablet) orally once daily for up to 50.3 weeks.

Participants received filgotinib placebo + lanraplenib placebo + tirabrutinib placebo tablets orally once daily for 24 weeks. At Week 24 Visit, participants were rerandomized 1:1:1, in a blinded fashion and received either of the three experimental study drugs orally once daily through Week 48:

  • lanraplenib (1 x 30 mg tablet) + filgotinib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet)
  • filgotinib (1 x 200 mg tablet) + lanraplenib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet)
  • tirabrutinib (1 x 40 mg tablet) + filgotinib placebo (1 x tablet) + lanraplenib placebo (1 x tablet)
Total of all reporting groups
Overall Number of Baseline Participants 37 38 39 36 150
Hide Baseline Analysis Population Description
The Safety Analysis Set included participants who received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 37 participants 38 participants 39 participants 36 participants 150 participants
56.2  (9.72) 52.2  (10.54) 55.8  (10.06) 53.2  (10.28) 54.4  (10.20)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 38 participants 39 participants 36 participants 150 participants
Female 36 38 37 35 146
Male 1 0 2 1 4
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 38 participants 39 participants 36 participants 150 participants
Hispanic or Latino 6 4 1 6 17
Not Hispanic or Latino 31 34 38 30 133
Unknown or Not Reported 0 0 0 0 0
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 38 participants 39 participants 36 participants 150 participants
American Indian or Alaska Native 0 0 0 1 1
Asian 0 1 1 0 2
Black 5 5 4 5 19
White 31 32 34 30 127
Other 1 0 0 0 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 37 participants 38 participants 39 participants 36 participants 150 participants
United States 26 27 30 23 106
Poland 7 4 5 6 22
Spain 2 4 3 4 13
United Kingdom 2 3 1 3 9
European League Against Rheumatism (EULAR) Sjogren's syndrome disease activity index (ESSDAI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 37 participants 38 participants 39 participants 36 participants 150 participants
10.5  (4.89) 10.2  (6.23) 10.4  (5.36) 9.3  (3.96) 10.1  (5.16)
[1]
Measure Description: Overall score (ranged from 0 (best) to 123 (worst activity)) was calculated as sum of all individual weighted domain scores. For additional details on this index, please see Outcome Measures# 2 and 4.
EULAR Sjogren's syndrome patient reported index (ESSPRI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 37 participants 38 participants 39 participants 36 participants 150 participants
6.6  (1.90) 6.3  (2.31) 5.9  (2.39) 5.9  (2.24) 6.2  (2.22)
[1]
Measure Description: The ESSPRI is a patient-reported questionnaire to assess subjective patient symptoms and includes 3 domains (dryness, pain, and fatigue). Each domain scored on scale of 0-10 (0 = no symptoms at all and 10 = worst symptoms imaginable), and an overall score is calculated as the mean of the three individual domain scores where all domains carry the same weight. Minimum score can be 0 and maximum score can be 10.
1.Primary Outcome
Title Percentage of Participants Fulfilling Protocol-Specified Response Criteria at Week 12, as Compared to Baseline
Hide Description Response was defined as: Improvement ≥ 20% in ≥ 3 of 5 participant-reported Sjogren's syndrome (SjS) related visual analogue score (VAS) measures (participant's assessment of global disease, pain, oral dryness, ocular dryness and fatigue), with no increase defined as > 30 mm from baseline (Day 1) in any of the above 5 VAS measures, AND either ≥ 20% improvement in high sensitivity C-reactive protein (hsCRP) (if hsCRP ≥ 1.5 x upper limit of normal [ULN] on Day 1) or no increase in hsCRP to ≥ 1.5 x ULN (if hsCRP < 1.5 x ULN on Day 1).
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set included all randomized participants who received at least one dose of study drug. Included participants with available data.
Arm/Group Title Lanraplenib Filgotinib Tirabrutinib Placebo
Hide Arm/Group Description:
Lanraplenib (1 x 30 mg tablet) + filgotinib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet) orally once daily for 48 weeks
Filgotinib (1 x 200 mg tablet) + lanraplenib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet) orally once daily for 48 weeks
Tirabrutinib (1 x 40 mg tablet) + filgotinib placebo (1 x tablet) + lanraplenib placebo (1 x tablet) orally once daily for 48 weeks

Participants received filgotinib placebo + lanraplenib placebo + tirabrutinib placebo tablets orally once daily for 24 weeks. At Week 24 Visit, participants were rerandomized 1:1:1, in a blinded fashion and received either of the three experimental study drugs orally once daily through Week 48:

  • filgotinib (1 x 200 mg tablet) + lanraplenib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet)
  • lanraplenib (1 x 30 mg tablet) + filgotinib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet)
  • tirabrutinib (1 x 40 mg tablet) + filgotinib placebo (1 x tablet) + lanraplenib placebo (1 x tablet)
Overall Number of Participants Analyzed 35 37 37 34
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
42.9
(25.0 to 60.7)
43.2
(25.9 to 60.6)
35.1
(18.4 to 51.9)
26.5
(10.2 to 42.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lanraplenib, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1597
Comments P-values were obtained from Cochran-Mantel-Haenszel (CMH) test stratified by randomization stratification factors.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Response Rates
Estimated Value 15.6
Confidence Interval (2-Sided) 95%
-6.3 to 37.6
Estimation Comments For the analysis of the difference in response rates, the data with missing response values were imputed by multiple imputation method with logistic regression.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Filgotinib, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1694
Comments P-values were obtained from CMH test stratified by randomization stratification factors.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Response Rates
Estimated Value 16.6
Confidence Interval (2-Sided) 95%
-5.1 to 38.3
Estimation Comments For the analysis of the difference in response rates, the data with missing response values were imputed by multiple imputation method with logistic regression.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tirabrutinib, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3309
Comments P-values were obtained from CMH test stratified by randomization stratification factors.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Response Rates
Estimated Value 8.1
Confidence Interval (2-Sided) 95%
-13.2 to 29.4
Estimation Comments For the analysis of the difference in response rates, the data with missing response values were imputed by multiple imputation method with logistic regression.
2.Secondary Outcome
Title Change From Baseline in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) at Week 12
Hide Description The ESSDAI is a physician-administered tool designed to measure disease activity. It consists of 12 organ-specific 'domains' contributing to disease activity associated with the participant's Sjogren's Syndrome only (constitutional, lymphadenopathy, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, hematological, biological). Each domain is assessed for activity level (i.e., no, low, moderate, high) and assigned a numerical score based on pre-determined weighting of each individual domain. Overall score (ranges from 0 (no activity) to 123 (worst activity)) is calculated as sum of all individual weighted domain scores. A negative change from baseline value indicates improvement.
Time Frame Baseline; Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title Lanraplenib Filgotinib Tirabrutinib Placebo
Hide Arm/Group Description:
Lanraplenib (1 x 30 mg tablet) + filgotinib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet) orally once daily for 48 weeks
Filgotinib (1 x 200 mg tablet) + lanraplenib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet) orally once daily for 48 weeks
Tirabrutinib (1 x 40 mg tablet) + filgotinib placebo (1 x tablet) + lanraplenib placebo (1 x tablet) orally once daily for 48 weeks

Participants received filgotinib placebo + lanraplenib placebo + tirabrutinib placebo tablets orally once daily for 24 weeks. At Week 24 Visit, participants were rerandomized 1:1:1, in a blinded fashion and received either of the three experimental study drugs orally once daily through Week 48:

  • filgotinib (1 x 200 mg tablet) + lanraplenib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet)
  • lanraplenib (1 x 30 mg tablet) + filgotinib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet)
  • tirabrutinib (1 x 40 mg tablet) + filgotinib placebo (1 x tablet) + lanraplenib placebo (1 x tablet)
Overall Number of Participants Analyzed 37 38 39 36
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-2.5  (0.76) -4.7  (0.72) -3.2  (0.73) -3.9  (0.76)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lanraplenib, Placebo
Comments Least Squares (LS) Means, 95% confidence interval (CI), and P-values were obtained from Mixed Effects Model for Repeated Measures (MMRM) with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2066
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.3
Confidence Interval (2-Sided) 95%
-0.7 to 3.4
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.05
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Filgotinib, Placebo
Comments LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3998
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.9
Confidence Interval (2-Sided) 95%
-2.9 to 1.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.04
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tirabrutinib, Placebo
Comments LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5113
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
-1.4 to 2.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.04
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) at Week 12
Hide Description The ESSPRI is a participant-reported questionnaire to assess subjective participant symptoms and includes 3 domains (dryness, pain, and fatigue). Each domain is scored on scale of 0-10 (0 = no symptom at all and 10 = worst symptom imaginable), and an overall score is calculated as the mean of the three individual domains where all domains carry the same weight. Minimum score can be 0 and maximum score can be 10. A negative change from baseline value indicates improvement.
Time Frame Baseline; Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title Lanraplenib Filgotinib Tirabrutinib Placebo
Hide Arm/Group Description:
Lanraplenib (1 x 30 mg tablet) + filgotinib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet) orally once daily for 48 weeks
Filgotinib (1 x 200 mg tablet) + lanraplenib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet) orally once daily for 48 weeks
Tirabrutinib (1 x 40 mg tablet) + filgotinib placebo (1 x tablet) + lanraplenib placebo (1 x tablet) orally once daily for 48 weeks

Participants received filgotinib placebo + lanraplenib placebo + tirabrutinib placebo tablets orally once daily for 24 weeks. At Week 24 Visit, participants were rerandomized 1:1:1, in a blinded fashion and received either of the three experimental study drugs orally once daily through Week 48:

  • filgotinib (1 x 200 mg tablet) + lanraplenib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet)
  • lanraplenib (1 x 30 mg tablet) + filgotinib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet)
  • tirabrutinib (1 x 40 mg tablet) + filgotinib placebo (1 x tablet) + lanraplenib placebo (1 x tablet)
Overall Number of Participants Analyzed 37 38 39 36
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-1.0  (0.34) -1.4  (0.33) -1.4  (0.33) -1.0  (0.34)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lanraplenib, Placebo
Comments LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9446
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.9 to 1.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.47
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Filgotinib, Placebo
Comments LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3977
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-1.3 to 0.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.47
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tirabrutinib, Placebo
Comments LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4966
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-1.2 to 0.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.47
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in ESSDAI at Week 24
Hide Description The ESSDAI is a physician-administered tool designed to measure disease activity. It consists of 12 organ-specific 'domains' contributing to disease activity associated with the participant's Sjogren's Syndrome only (constitutional, lymphadenopathy, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, hematological, biological). Each domain is assessed for activity level (i.e., no, low, moderate, high) and assigned a numerical score based on pre-determined weighting of each individual domain. Overall score (ranges from 0 (no activity) to 123 (worst activity)) is calculated as sum of all individual weighted domain scores. A negative change from baseline value indicates improvement.
Time Frame Baseline; Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title Lanraplenib Filgotinib Tirabrutinib Placebo
Hide Arm/Group Description:
Lanraplenib (1 x 30 mg tablet) + filgotinib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet) orally once daily for 48 weeks
Filgotinib (1 x 200 mg tablet) + lanraplenib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet) orally once daily for 48 weeks
Tirabrutinib (1 x 40 mg tablet) + filgotinib placebo (1 x tablet) + lanraplenib placebo (1 x tablet) orally once daily for 48 weeks

Participants received filgotinib placebo + lanraplenib placebo + tirabrutinib placebo tablets orally once daily for 24 weeks. At Week 24 Visit, participants were rerandomized 1:1:1, in a blinded fashion and received either of the three experimental study drugs orally once daily through Week 48:

  • filgotinib (1 x 200 mg tablet) + lanraplenib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet)
  • lanraplenib (1 x 30 mg tablet) + filgotinib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet)
  • tirabrutinib (1 x 40 mg tablet) + filgotinib placebo (1 x tablet) + lanraplenib placebo (1 x tablet)
Overall Number of Participants Analyzed 37 38 39 36
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-4.3  (0.81) -5.4  (0.75) -4.0  (0.75) -4.2  (0.78)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lanraplenib, Placebo
Comments LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9564
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-2.2 to 2.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Filgotinib, Placebo
Comments LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2788
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.2
Confidence Interval (2-Sided) 95%
-3.3 to 0.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.07
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tirabrutinib, Placebo
Comments LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8047
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-1.8 to 2.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.06
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in ESSPRI at Week 24
Hide Description The ESSPRI is a participant-reported questionnaire to assess subjective participant symptoms and includes 3 domains (dryness, pain, and fatigue). Each domain is scored on scale of 0-10 (0 = no symptom at all and 10 = worst symptom imaginable), and an overall score is calculated as the mean of the three individual domains where all domains carry the same weight. Minimum score can be 0 and maximum score can be 10. A negative change from baseline value indicates improvement.
Time Frame Baseline; Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title Lanraplenib Filgotinib Tirabrutinib Placebo
Hide Arm/Group Description:
Lanraplenib (1 x 30 mg tablet) + filgotinib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet) orally once daily for 48 weeks
Filgotinib (1 x 200 mg tablet) + lanraplenib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet) orally once daily for 48 weeks
Tirabrutinib (1 x 40 mg tablet) + filgotinib placebo (1 x tablet) + lanraplenib placebo (1 x tablet) orally once daily for 48 weeks

Participants received filgotinib placebo + lanraplenib placebo + tirabrutinib placebo tablets orally once daily for 24 weeks. At Week 24 Visit, participants were rerandomized 1:1:1, in a blinded fashion and received either of the three experimental study drugs orally once daily through Week 48:

  • filgotinib (1 x 200 mg tablet) + lanraplenib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet)
  • lanraplenib (1 x 30 mg tablet) + filgotinib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet)
  • tirabrutinib (1 x 40 mg tablet) + filgotinib placebo (1 x tablet) + lanraplenib placebo (1 x tablet)
Overall Number of Participants Analyzed 37 38 39 36
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-1.1  (0.34) -0.8  (0.31) -1.2  (0.31) -0.9  (0.33)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lanraplenib, Placebo
Comments LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6782
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-1.1 to 0.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.46
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Filgotinib, Placebo
Comments LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9171
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.8 to 0.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.45
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Tirabrutinib, Placebo
Comments LS Means, 95% CI, and P-values were obtained from MMRM with the terms for baseline value, treatment, stratification factors, visit, and treatment-by-visit interaction.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4641
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-1.2 to 0.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.45
Estimation Comments [Not Specified]
Time Frame First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
Adverse Event Reporting Description The Safety Analysis Set included participants who received at least one dose of study drug.
 
Arm/Group Title Lanraplenib Filgotinib Tirabrutinib Placebo to Lanraplenib Placebo to Filgotinib Placebo to Tirabrutinib Placebo on Placebo Controlled Period
Hide Arm/Group Description Lanraplenib (1 x 30 mg tablet) + filgotinib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet) orally once daily for up to 49.4 weeks. Filgotinib (1 x 200 mg tablet) + lanraplenib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet) orally once daily for up to 50.4 weeks. Tirabrutinib (1 x 40 mg tablet) + filgotinib placebo (1 x tablet) + lanraplenib placebo (1 x tablet) orally once daily for up to 50.3 weeks. Participants who received placebo for 24 weeks were rerandomized at the Week 24 visit and received lanraplenib (1 × 30 mg tablet) + filgotinib placebo (1 × tablet) + tirabrutinib placebo (1 × tablet) orally once daily for up to 25.1 weeks. Participants who received placebo for 24 weeks were rerandomized at the Week 24 visit and received filgotinib (1 × 200 mg tablet) + lanraplenib placebo (1 × tablet) + tirabrutinib placebo (1 × tablet) orally once daily for up to 24.4 weeks. Participants who received placebo for 24 weeks were rerandomized at the Week 24 visit and received tirabrutinib (1 × 40 mg tablet) + filgotinib placebo (1 × tablet) + lanraplenib placebo (1 × tablet) orally once daily for up to 24.9 weeks.

Participants received filgotinib placebo + lanraplenib placebo + tirabrutinib placebo tablets orally once daily for 24 weeks in placebo controlled period.

At Week 24 visit, participants were re-randomized 1:1:1, in a blinded fashion and receive either of the following study drugs through Week 48:

  • filgotinib + lanraplenib placebo + tirabrutinib placebo
  • lanraplenib + filgotinib placebo + tirabrutinib placebo
  • tirabrutinib + filgotinib placebo + lanraplenib placeboy once daily for 24 weeks.
All-Cause Mortality
Lanraplenib Filgotinib Tirabrutinib Placebo to Lanraplenib Placebo to Filgotinib Placebo to Tirabrutinib Placebo on Placebo Controlled Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/37 (0.00%)   0/38 (0.00%)   0/39 (0.00%)   0/10 (0.00%)   0/12 (0.00%)   0/10 (0.00%)   0/36 (0.00%) 
Hide Serious Adverse Events
Lanraplenib Filgotinib Tirabrutinib Placebo to Lanraplenib Placebo to Filgotinib Placebo to Tirabrutinib Placebo on Placebo Controlled Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/37 (8.11%)   5/38 (13.16%)   1/39 (2.56%)   0/10 (0.00%)   1/12 (8.33%)   0/10 (0.00%)   2/36 (5.56%) 
Cardiac disorders               
Acute coronary syndrome  1  1/37 (2.70%)  0/38 (0.00%)  0/39 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/10 (0.00%)  0/36 (0.00%) 
Gastrointestinal disorders               
Gastrooesophageal reflux disease  1  0/37 (0.00%)  0/38 (0.00%)  0/39 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/10 (0.00%)  1/36 (2.78%) 
Pancreatitis  1  0/37 (0.00%)  1/38 (2.63%)  0/39 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/10 (0.00%)  0/36 (0.00%) 
Pancreatitis acute  1  1/37 (2.70%)  0/38 (0.00%)  0/39 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/10 (0.00%)  0/36 (0.00%) 
Infections and infestations               
Diverticulitis  1  0/37 (0.00%)  1/38 (2.63%)  0/39 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/10 (0.00%)  0/36 (0.00%) 
Musculoskeletal and connective tissue disorders               
Arthralgia  1  0/37 (0.00%)  0/38 (0.00%)  1/39 (2.56%)  0/10 (0.00%)  0/12 (0.00%)  0/10 (0.00%)  0/36 (0.00%) 
Rheumatoid arthritis  1  0/37 (0.00%)  0/38 (0.00%)  0/39 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/10 (0.00%)  1/36 (2.78%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)               
Breast cancer  1  0/37 (0.00%)  0/38 (0.00%)  0/39 (0.00%)  0/10 (0.00%)  1/12 (8.33%)  0/10 (0.00%)  0/36 (0.00%) 
Nervous system disorders               
Migraine  1  0/37 (0.00%)  1/38 (2.63%)  0/39 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/10 (0.00%)  0/36 (0.00%) 
Psychiatric disorders               
Suicidal ideation  1  1/37 (2.70%)  0/38 (0.00%)  0/39 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/10 (0.00%)  0/36 (0.00%) 
Renal and urinary disorders               
Renal failure  1  0/37 (0.00%)  1/38 (2.63%)  0/39 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/10 (0.00%)  0/36 (0.00%) 
Respiratory, thoracic and mediastinal disorders               
Interstitial lung disease  1  0/37 (0.00%)  1/38 (2.63%)  0/39 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/10 (0.00%)  0/36 (0.00%) 
1
Term from vocabulary, MedDRA 22.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lanraplenib Filgotinib Tirabrutinib Placebo to Lanraplenib Placebo to Filgotinib Placebo to Tirabrutinib Placebo on Placebo Controlled Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   30/37 (81.08%)   31/38 (81.58%)   32/39 (82.05%)   10/10 (100.00%)   10/12 (83.33%)   7/10 (70.00%)   23/36 (63.89%) 
Blood and lymphatic system disorders               
Anaemia  1  1/37 (2.70%)  0/38 (0.00%)  2/39 (5.13%)  0/10 (0.00%)  0/12 (0.00%)  0/10 (0.00%)  0/36 (0.00%) 
Lymphadenopathy  1  2/37 (5.41%)  0/38 (0.00%)  0/39 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  1/10 (10.00%)  0/36 (0.00%) 
Lymphopenia  1  0/37 (0.00%)  0/38 (0.00%)  0/39 (0.00%)  0/10 (0.00%)  1/12 (8.33%)  0/10 (0.00%)  0/36 (0.00%) 
Neutropenia  1  2/37 (5.41%)  2/38 (5.26%)  0/39 (0.00%)  0/10 (0.00%)  1/12 (8.33%)  0/10 (0.00%)  0/36 (0.00%) 
Eye disorders               
Corneal erosion  1  0/37 (0.00%)  0/38 (0.00%)  0/39 (0.00%)  1/10 (10.00%)  0/12 (0.00%)  0/10 (0.00%)  0/36 (0.00%) 
Vision blurred  1  0/37 (0.00%)  1/38 (2.63%)  1/39 (2.56%)  0/10 (0.00%)  1/12 (8.33%)  0/10 (0.00%)  0/36 (0.00%) 
Gastrointestinal disorders               
Abdominal pain upper  1  0/37 (0.00%)  1/38 (2.63%)  1/39 (2.56%)  0/10 (0.00%)  0/12 (0.00%)  1/10 (10.00%)  0/36 (0.00%) 
Constipation  1  0/37 (0.00%)  0/38 (0.00%)  3/39 (7.69%)  0/10 (0.00%)  0/12 (0.00%)  0/10 (0.00%)  0/36 (0.00%) 
Dental caries  1  2/37 (5.41%)  0/38 (0.00%)  0/39 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/10 (0.00%)  0/36 (0.00%) 
Diarrhoea  1  3/37 (8.11%)  3/38 (7.89%)  3/39 (7.69%)  1/10 (10.00%)  2/12 (16.67%)  0/10 (0.00%)  1/36 (2.78%) 
Food poisoning  1  0/37 (0.00%)  1/38 (2.63%)  0/39 (0.00%)  0/10 (0.00%)  1/12 (8.33%)  0/10 (0.00%)  0/36 (0.00%) 
Gastrooesophageal reflux disease  1  0/37 (0.00%)  0/38 (0.00%)  1/39 (2.56%)  0/10 (0.00%)  1/12 (8.33%)  0/10 (0.00%)  1/36 (2.78%) 
Lip blister  1  0/37 (0.00%)  2/38 (5.26%)  0/39 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/10 (0.00%)  0/36 (0.00%) 
Nausea  1  2/37 (5.41%)  4/38 (10.53%)  2/39 (5.13%)  0/10 (0.00%)  0/12 (0.00%)  0/10 (0.00%)  1/36 (2.78%) 
Vomiting  1  2/37 (5.41%)  3/38 (7.89%)  2/39 (5.13%)  0/10 (0.00%)  0/12 (0.00%)  0/10 (0.00%)  0/36 (0.00%) 
General disorders               
Asthenia  1  0/37 (0.00%)  1/38 (2.63%)  0/39 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  1/10 (10.00%)  0/36 (0.00%) 
Fatigue  1  4/37 (10.81%)  0/38 (0.00%)  3/39 (7.69%)  2/10 (20.00%)  1/12 (8.33%)  0/10 (0.00%)  2/36 (5.56%) 
Pyrexia  1  3/37 (8.11%)  0/38 (0.00%)  0/39 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/10 (0.00%)  1/36 (2.78%) 
Immune system disorders               
Seasonal allergy  1  1/37 (2.70%)  1/38 (2.63%)  2/39 (5.13%)  0/10 (0.00%)  1/12 (8.33%)  0/10 (0.00%)  0/36 (0.00%) 
Infections and infestations               
Bronchitis  1  2/37 (5.41%)  3/38 (7.89%)  1/39 (2.56%)  0/10 (0.00%)  1/12 (8.33%)  0/10 (0.00%)  3/36 (8.33%) 
Conjunctivitis viral  1  0/37 (0.00%)  0/38 (0.00%)  0/39 (0.00%)  0/10 (0.00%)  1/12 (8.33%)  0/10 (0.00%)  0/36 (0.00%) 
Fungal skin infection  1  0/37 (0.00%)  0/38 (0.00%)  0/39 (0.00%)  0/10 (0.00%)  1/12 (8.33%)  0/10 (0.00%)  0/36 (0.00%) 
Furuncle  1  1/37 (2.70%)  0/38 (0.00%)  1/39 (2.56%)  0/10 (0.00%)  1/12 (8.33%)  0/10 (0.00%)  0/36 (0.00%) 
Gastroenteritis viral  1  3/37 (8.11%)  2/38 (5.26%)  3/39 (7.69%)  2/10 (20.00%)  0/12 (0.00%)  0/10 (0.00%)  0/36 (0.00%) 
Helicobacter infection  1  0/37 (0.00%)  0/38 (0.00%)  0/39 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  1/10 (10.00%)  1/36 (2.78%) 
Herpes zoster  1  0/37 (0.00%)  2/38 (5.26%)  0/39 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/10 (0.00%)  0/36 (0.00%) 
Influenza  1  1/37 (2.70%)  0/38 (0.00%)  3/39 (7.69%)  0/10 (0.00%)  1/12 (8.33%)  0/10 (0.00%)  0/36 (0.00%) 
Laryngitis  1  2/37 (5.41%)  0/38 (0.00%)  0/39 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/10 (0.00%)  0/36 (0.00%) 
Lower respiratory tract infection  1  2/37 (5.41%)  0/38 (0.00%)  1/39 (2.56%)  0/10 (0.00%)  0/12 (0.00%)  0/10 (0.00%)  0/36 (0.00%) 
Nasopharyngitis  1  3/37 (8.11%)  6/38 (15.79%)  4/39 (10.26%)  1/10 (10.00%)  1/12 (8.33%)  2/10 (20.00%)  4/36 (11.11%) 
Oral herpes  1  2/37 (5.41%)  3/38 (7.89%)  0/39 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/10 (0.00%)  0/36 (0.00%) 
Otitis media  1  0/37 (0.00%)  1/38 (2.63%)  0/39 (0.00%)  0/10 (0.00%)  1/12 (8.33%)  0/10 (0.00%)  0/36 (0.00%) 
Pharyngitis  1  0/37 (0.00%)  2/38 (5.26%)  0/39 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/10 (0.00%)  2/36 (5.56%) 
Pneumonia  1  0/37 (0.00%)  2/38 (5.26%)  1/39 (2.56%)  0/10 (0.00%)  0/12 (0.00%)  0/10 (0.00%)  0/36 (0.00%) 
Sinusitis  1  2/37 (5.41%)  1/38 (2.63%)  5/39 (12.82%)  1/10 (10.00%)  0/12 (0.00%)  0/10 (0.00%)  3/36 (8.33%) 
Upper respiratory tract infection  1  4/37 (10.81%)  6/38 (15.79%)  9/39 (23.08%)  0/10 (0.00%)  1/12 (8.33%)  0/10 (0.00%)  4/36 (11.11%) 
Urinary tract infection  1  1/37 (2.70%)  2/38 (5.26%)  4/39 (10.26%)  2/10 (20.00%)  2/12 (16.67%)  0/10 (0.00%)  6/36 (16.67%) 
Vaginal infection  1  0/37 (0.00%)  0/38 (0.00%)  0/39 (0.00%)  1/10 (10.00%)  0/12 (0.00%)  0/10 (0.00%)  0/36 (0.00%) 
Viral pharyngitis  1  0/37 (0.00%)  0/38 (0.00%)  0/39 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  1/10 (10.00%)  0/36 (0.00%) 
Vulvovaginal mycotic infection  1  0/37 (0.00%)  0/38 (0.00%)  2/39 (5.13%)  0/10 (0.00%)  0/12 (0.00%)  0/10 (0.00%)  0/36 (0.00%) 
Injury, poisoning and procedural complications               
Arthropod bite  1  0/37 (0.00%)  0/38 (0.00%)  0/39 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  1/10 (10.00%)  0/36 (0.00%) 
Contusion  1  0/37 (0.00%)  2/38 (5.26%)  2/39 (5.13%)  0/10 (0.00%)  0/12 (0.00%)  0/10 (0.00%)  1/36 (2.78%) 
Fall  1  1/37 (2.70%)  2/38 (5.26%)  2/39 (5.13%)  0/10 (0.00%)  1/12 (8.33%)  0/10 (0.00%)  0/36 (0.00%) 
Investigations               
Alanine aminotransferase increased  1  4/37 (10.81%)  1/38 (2.63%)  2/39 (5.13%)  0/10 (0.00%)  0/12 (0.00%)  0/10 (0.00%)  0/36 (0.00%) 
Aspartate aminotransferase increased  1  4/37 (10.81%)  1/38 (2.63%)  1/39 (2.56%)  0/10 (0.00%)  0/12 (0.00%)  0/10 (0.00%)  0/36 (0.00%) 
Blood creatine phosphokinase increased  1  0/37 (0.00%)  0/38 (0.00%)  0/39 (0.00%)  0/10 (0.00%)  1/12 (8.33%)  0/10 (0.00%)  0/36 (0.00%) 
Blood potassium increased  1  0/37 (0.00%)  0/38 (0.00%)  0/39 (0.00%)  0/10 (0.00%)  1/12 (8.33%)  0/10 (0.00%)  0/36 (0.00%) 
Light chain analysis increased  1  0/37 (0.00%)  0/38 (0.00%)  1/39 (2.56%)  1/10 (10.00%)  0/12 (0.00%)  0/10 (0.00%)  0/36 (0.00%) 
Liver function test abnormal  1  0/37 (0.00%)  0/38 (0.00%)  0/39 (0.00%)  1/10 (10.00%)  0/12 (0.00%)  0/10 (0.00%)  0/36 (0.00%) 
Transaminases increased  1  0/37 (0.00%)  0/38 (0.00%)  0/39 (0.00%)  1/10 (10.00%)  0/12 (0.00%)  0/10 (0.00%)  0/36 (0.00%) 
Musculoskeletal and connective tissue disorders               
Arthralgia  1  4/37 (10.81%)  4/38 (10.53%)  6/39 (15.38%)  0/10 (0.00%)  0/12 (0.00%)  0/10 (0.00%)  0/36 (0.00%) 
Back pain  1  1/37 (2.70%)  1/38 (2.63%)  1/39 (2.56%)  0/10 (0.00%)  0/12 (0.00%)  1/10 (10.00%)  0/36 (0.00%) 
Exostosis  1  0/37 (0.00%)  0/38 (0.00%)  0/39 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  1/10 (10.00%)  0/36 (0.00%) 
Muscle spasms  1  0/37 (0.00%)  2/38 (5.26%)  2/39 (5.13%)  0/10 (0.00%)  0/12 (0.00%)  0/10 (0.00%)  0/36 (0.00%) 
Musculoskeletal pain  1  1/37 (2.70%)  1/38 (2.63%)  0/39 (0.00%)  0/10 (0.00%)  1/12 (8.33%)  0/10 (0.00%)  0/36 (0.00%) 
Myalgia  1  2/37 (5.41%)  0/38 (0.00%)  1/39 (2.56%)  1/10 (10.00%)  0/12 (0.00%)  1/10 (10.00%)  1/36 (2.78%) 
Neck pain  1  0/37 (0.00%)  1/38 (2.63%)  1/39 (2.56%)  2/10 (20.00%)  0/12 (0.00%)  0/10 (0.00%)  0/36 (0.00%) 
Osteoarthritis  1  1/37 (2.70%)  2/38 (5.26%)  0/39 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  1/10 (10.00%)  1/36 (2.78%) 
Pain in extremity  1  0/37 (0.00%)  3/38 (7.89%)  0/39 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/10 (0.00%)  0/36 (0.00%) 
Rheumatoid arthritis  1  1/37 (2.70%)  1/38 (2.63%)  0/39 (0.00%)  1/10 (10.00%)  0/12 (0.00%)  0/10 (0.00%)  0/36 (0.00%) 
Temporomandibular joint syndrome  1  0/37 (0.00%)  1/38 (2.63%)  0/39 (0.00%)  2/10 (20.00%)  0/12 (0.00%)  0/10 (0.00%)  0/36 (0.00%) 
Nervous system disorders               
Dizziness  1  3/37 (8.11%)  1/38 (2.63%)  1/39 (2.56%)  0/10 (0.00%)  0/12 (0.00%)  0/10 (0.00%)  3/36 (8.33%) 
Headache  1  0/37 (0.00%)  3/38 (7.89%)  3/39 (7.69%)  1/10 (10.00%)  1/12 (8.33%)  1/10 (10.00%)  1/36 (2.78%) 
Migraine  1  1/37 (2.70%)  1/38 (2.63%)  0/39 (0.00%)  0/10 (0.00%)  1/12 (8.33%)  0/10 (0.00%)  0/36 (0.00%) 
Sciatica  1  0/37 (0.00%)  3/38 (7.89%)  0/39 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/10 (0.00%)  0/36 (0.00%) 
Psychiatric disorders               
Insomnia  1  1/37 (2.70%)  1/38 (2.63%)  2/39 (5.13%)  0/10 (0.00%)  0/12 (0.00%)  1/10 (10.00%)  1/36 (2.78%) 
Respiratory, thoracic and mediastinal disorders               
Allergic sinusitis  1  0/37 (0.00%)  0/38 (0.00%)  0/39 (0.00%)  0/10 (0.00%)  1/12 (8.33%)  0/10 (0.00%)  0/36 (0.00%) 
Cough  1  0/37 (0.00%)  1/38 (2.63%)  3/39 (7.69%)  0/10 (0.00%)  0/12 (0.00%)  1/10 (10.00%)  3/36 (8.33%) 
Epistaxis  1  0/37 (0.00%)  0/38 (0.00%)  1/39 (2.56%)  0/10 (0.00%)  0/12 (0.00%)  1/10 (10.00%)  0/36 (0.00%) 
Oropharyngeal pain  1  0/37 (0.00%)  2/38 (5.26%)  0/39 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  1/10 (10.00%)  0/36 (0.00%) 
Skin and subcutaneous tissue disorders               
Alopecia  1  0/37 (0.00%)  2/38 (5.26%)  2/39 (5.13%)  0/10 (0.00%)  1/12 (8.33%)  0/10 (0.00%)  2/36 (5.56%) 
Hyperhidrosis  1  1/37 (2.70%)  2/38 (5.26%)  0/39 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/10 (0.00%)  0/36 (0.00%) 
Pruritus  1  0/37 (0.00%)  0/38 (0.00%)  0/39 (0.00%)  1/10 (10.00%)  0/12 (0.00%)  0/10 (0.00%)  0/36 (0.00%) 
Pruritus generalised  1  2/37 (5.41%)  0/38 (0.00%)  0/39 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  0/10 (0.00%)  0/36 (0.00%) 
Rash  1  4/37 (10.81%)  2/38 (5.26%)  3/39 (7.69%)  0/10 (0.00%)  0/12 (0.00%)  0/10 (0.00%)  2/36 (5.56%) 
Rash macular  1  0/37 (0.00%)  0/38 (0.00%)  2/39 (5.13%)  0/10 (0.00%)  0/12 (0.00%)  0/10 (0.00%)  0/36 (0.00%) 
Rash papular  1  1/37 (2.70%)  0/38 (0.00%)  2/39 (5.13%)  0/10 (0.00%)  0/12 (0.00%)  0/10 (0.00%)  0/36 (0.00%) 
Rash pruritic  1  1/37 (2.70%)  0/38 (0.00%)  1/39 (2.56%)  1/10 (10.00%)  0/12 (0.00%)  0/10 (0.00%)  0/36 (0.00%) 
Skin lesion  1  0/37 (0.00%)  0/38 (0.00%)  0/39 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  1/10 (10.00%)  0/36 (0.00%) 
Urticaria  1  0/37 (0.00%)  0/38 (0.00%)  0/39 (0.00%)  1/10 (10.00%)  0/12 (0.00%)  0/10 (0.00%)  0/36 (0.00%) 
Vascular disorders               
Hypertension  1  0/37 (0.00%)  3/38 (7.89%)  3/39 (7.69%)  0/10 (0.00%)  1/12 (8.33%)  0/10 (0.00%)  0/36 (0.00%) 
Vasculitis  1  0/37 (0.00%)  0/38 (0.00%)  0/39 (0.00%)  0/10 (0.00%)  0/12 (0.00%)  1/10 (10.00%)  0/36 (0.00%) 
1
Term from vocabulary, MedDRA 22.0
Indicates events were collected by systematic assessment
An unplanned review of unblinded clinical trial data was performed in this study that was not prospectively specified in the protocol. There was no impact on the overall integrity or conclusions of the study.
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: NCT03100942    
Other Study ID Numbers: GS-US-445-4189
2016-003558-34 ( EudraCT Number )
First Submitted: March 31, 2017
First Posted: April 4, 2017
Results First Submitted: December 19, 2019
Results First Posted: January 22, 2020
Last Update Posted: October 23, 2020