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Study to Evaluate Safety and Efficacy of Filgotinib and Lanraplenib in Females With Moderately-to-Severely Active Cutaneous Lupus Erythematosus (CLE)

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ClinicalTrials.gov Identifier: NCT03134222
Recruitment Status : Completed
First Posted : April 28, 2017
Results First Posted : April 8, 2020
Last Update Posted : June 9, 2020
Sponsor:
Collaborator:
Galapagos NV
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Cutaneous Lupus Erythematosus
Interventions Drug: Lanraplenib
Drug: Filgotinib
Drug: Lanraplenib placebo
Drug: Filgotinib placebo
Enrollment 47
Recruitment Details Participants were enrolled at study sites in the United States and Canada. The first participant was screened on 24 May 2017. The last study visit occurred on 18 December 2019.
Pre-assignment Details 72 participants were screened.
Arm/Group Title Lanraplenib 30 mg Filgotinib 200 mg Placebo Placebo to Lanraplenib 30 mg Placebo to Filgotinib 200 mg
Hide Arm/Group Description Lanraplenib 30 mg + filgotinib placebo tablets orally once daily for 48 weeks Filgotinib 200 mg + lanraplenib placebo tablets orally once daily for 48 weeks Participants received filgotinib placebo + lanraplenib placebo tablets orally once daily for 12 weeks. After Week 12 Visit, participants on placebo were rerandomized 1:1 and received lanraplenib 30 mg + filgotinib placebo once daily in a blinded fashion through Week 48. After Week 12 Visit, participants on placebo were rerandomized 1:1 and received filgotinib 200 mg + lanraplenib placebo once daily in a blinded fashion through Week 48.
Period Title: Treatment Period (Up to Week 12)
Started 19 18 10 0 0
Completed 14 14 8 0 0
Not Completed 5 4 2 0 0
Reason Not Completed
Adverse Event             4             1             0             0             0
Lost to Follow-up             1             1             1             0             0
Withdrew Consent             0             1             0             0             0
Randomized but not treated             0             1             1             0             0
Period Title: Treatment Period (Week 12 to 48)
Started 14 14 0 [1] 4 [2] 4 [2]
Completed 12 11 0 3 3
Not Completed 2 3 0 1 1
Reason Not Completed
Withdrew Consent             0             2             0             0             1
Lack of Efficacy             2             0             0             0             0
Investigator's Discretion             0             0             0             1             0
Lost to Follow-up             0             1             0             0             0
[1]
Participants were rerandomized 1:1 to either Placebo to Lanraplenib or Placebo to Filgotinib arm.
[2]
Participants were rerandomized from the Placebo arm.
Arm/Group Title Lanraplenib 30 mg Filgotinib 200 mg Placebo Total
Hide Arm/Group Description Lanraplenib 30 mg + filgotinib placebo tablets orally once daily for 48 weeks Filgotinib 200 mg + lanraplenib placebo tablets orally once daily for 48 weeks Participants received filgotinib placebo + lanraplenib placebo tablets orally once daily for 12 weeks. After Week 12 Visit, participants were rerandomized 1:1 and received filgotinib 200 mg + lanraplenib placebo or lanraplenib 30 mg + filgotinib placebo once daily in a blinded fashion through Week 48. Total of all reporting groups
Overall Number of Baseline Participants 19 17 9 45
Hide Baseline Analysis Population Description
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 17 participants 9 participants 45 participants
51  (9.0) 43  (11.5) 46  (7.3) 47  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 17 participants 9 participants 45 participants
Female 19 17 9 45
Male 0 0 0 0
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 17 participants 9 participants 45 participants
American Indian or Alaska Native 1 0 0 1
Asian 0 0 2 2
Black 6 8 1 15
Native Hawaiian or Pacific Islander 0 0 0 0
White 12 7 6 25
Other 0 2 0 2
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 17 participants 9 participants 45 participants
Hispanic or Latino 3 4 2 9
Not Hispanic or Latino 16 13 7 36
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants 17 participants 9 participants 45 participants
Canada 4 1 3 8
United States 15 16 6 37
Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 19 participants 17 participants 9 participants 45 participants
17.1  (6.11) 19.7  (14.35) 14.8  (4.79) 17.6  (9.89)
[1]
Measure Description:

CLASI Activity score ranges from 0-70, higher scores indicate more severe skin disease. For additional details on this index, please see Outcome Measure#1.

Measure Analysis Population Description: Participants in the Full Analysis Set (who were randomized and received at least one dose of study drug (filgotinib, lanraplenib or placebo) were analyzed.

1.Primary Outcome
Title Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score From Baseline to Week 12
Hide Description CLASI Activity is scored based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and nonscarring alopecia. Evaluation of erythema and scale/hyperkeratosis is based on a table: rows represent anatomical areas and columns represent major clinical symptoms. The extent of involvement for each of the skin symptoms is documented for each anatomic area. The total score ranges from 0-70, with higher scores indicating more severe skin disease.
Time Frame Baseline; Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Treatment policy-estimand is the primary estimand for the primary endpoint analysis which involved participants in the Full Analysis Set (who were randomized and received at least one dose of study drug [filgotinib, lanraplenib or placebo]) with available data.
Arm/Group Title Lanraplenib 30 mg Filgotinib 200 mg Placebo
Hide Arm/Group Description:
Lanraplenib 30 mg + filgotinib placebo tablets orally once daily for 48 weeks
Filgotinib 200 mg + lanraplenib placebo tablets orally once daily for 48 weeks
Participants received filgotinib placebo + lanraplenib placebo tablets orally once daily for 12 weeks.
Overall Number of Participants Analyzed 16 16 8
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-4.5  (1.91) -8.7  (1.85) -5.5  (2.56)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lanraplenib 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7500
Comments [Not Specified]
Method Mixed-effect repeated measures model
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3047
Comments [Not Specified]
Method Mixed-effect repeated measures model
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants at Week 12 With Decrease of ≥ 5 Points in CLASI Activity Score From Baseline
Hide Description CLASI Activity is scored based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and nonscarring alopecia. Evaluation of erythema and scale/hyperkeratosis is based on a table: rows represent anatomical areas and columns represent major clinical symptoms. The extent of involvement for each of the skin symptoms is documented for each anatomic area. The total score ranges from 0-70, with higher scores indicating more severe skin disease.
Time Frame Baseline; Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed. Missing data are imputed as No Response.
Arm/Group Title Lanraplenib 30 mg Filgotinib 200 mg Placebo
Hide Arm/Group Description:
Lanraplenib 30 mg + filgotinib placebo tablets orally once daily for 48 weeks
Filgotinib 200 mg + lanraplenib placebo tablets orally once daily for 48 weeks
Participants received filgotinib placebo + lanraplenib placebo tablets orally once daily for 12 weeks.
Overall Number of Participants Analyzed 19 17 9
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
47.4
(24.4 to 71.1)
64.7
(38.3 to 85.8)
44.4
(13.7 to 78.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lanraplenib 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8869
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3293
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants at Week 12 With No Worsening in CLASI Activity Score From Baseline
Hide Description CLASI Activity is scored based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and nonscarring alopecia. Evaluation of erythema and scale/hyperkeratosis is based on a table: rows represent anatomical areas and columns represent major clinical symptoms. The extent of involvement for each of the skin symptoms is documented for each anatomic area. The total score ranges from 0-70, with higher scores indicating more severe skin disease. Worsening was defined as ≥ 3 point increase in CLASI activity score.
Time Frame Baseline; Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed. Missing data are imputed as No Response.
Arm/Group Title Lanraplenib 30 mg Filgotinib 200 mg Placebo
Hide Arm/Group Description:
Lanraplenib 30 mg + filgotinib placebo tablets orally once daily for 48 weeks
Filgotinib 200 mg + lanraplenib placebo tablets orally once daily for 48 weeks
Participants received filgotinib placebo + lanraplenib placebo tablets orally once daily for 12 weeks.
Overall Number of Participants Analyzed 19 17 9
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
84.2
(60.4 to 96.6)
94.1
(71.3 to 99.9)
88.9
(51.8 to 99.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lanraplenib 30 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7456
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6407
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants at Week 24 With Decrease of ≥ 5 Points in CLASI Activity Score From Baseline
Hide Description CLASI Activity is scored based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and nonscarring alopecia. Evaluation of erythema and scale/hyperkeratosis is based on a table: rows represent anatomical areas and columns represent major clinical symptoms. The extent of involvement for each of the skin symptoms is documented for each anatomic area. The total score ranges from 0-70, with higher scores indicating more severe skin disease.
Time Frame Baseline; Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set who were randomized to Filgotinib 200 mg or Lanraplenib 200 mg.
Arm/Group Title Lanraplenib 30 mg Filgotinib 200 mg
Hide Arm/Group Description:
Lanraplenib 30 mg + filgotinib placebo tablets orally once daily for 48 weeks
Filgotinib 200 mg + lanraplenib placebo tablets orally once daily for 48 weeks
Overall Number of Participants Analyzed 14 12
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
50.0
(23.0 to 77.0)
83.3
(51.6 to 97.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lanraplenib 30 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method One sample exact binomial test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method One sample exact binomial test
Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants at Week 24 With No Worsening in CLASI Activity Score From Baseline
Hide Description CLASI Activity is scored based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and nonscarring alopecia. Evaluation of erythema and scale/hyperkeratosis is based on a table: rows represent anatomical areas and columns represent major clinical symptoms. The extent of involvement for each of the skin symptoms is documented for each anatomic area. The total score ranges from 0-70, with higher scores indicating more severe skin disease. Worsening was defined as ≥ 3 point increase in CLASI activity score.
Time Frame Baseline; Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set who were randomized to Filgotinib 200 mg or Lanraplenib 200 mg.
Arm/Group Title Lanraplenib 30 mg Filgotinib 200 mg
Hide Arm/Group Description:
Lanraplenib 30 mg + filgotinib placebo tablets orally once daily for 48 weeks
Filgotinib 200 mg + lanraplenib placebo tablets orally once daily for 48 weeks
Overall Number of Participants Analyzed 14 12
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
85.7
(57.2 to 98.2)
100.0
(73.5 to 100.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lanraplenib 30 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method One sample exact binomial test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method One sample exact binomial test
Comments [Not Specified]
Time Frame First dose date up to Week 48 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 30 mg Filgotinib 200 mg Placebo Placebo to Lanraplenib 30 mg Placebo to Filgotinib 200 mg
Hide Arm/Group Description Lanraplenib 30 mg + filgotinib placebo tablets orally once daily for 48 weeks Filgotinib 200 mg + lanraplenib placebo tablets orally once daily for 48 weeks Participants received filgotinib placebo + lanraplenib placebo tablets orally once daily for 12 weeks. After Week 12 Visit, participants on placebo were rerandomized 1:1 and received lanraplenib 30 mg + filgotinib placebo once daily in a blinded fashion through Week 48. After Week 12 Visit, participants on placebo were rerandomized 1:1 and received filgotinib 200 mg + lanraplenib placebo once daily in a blinded fashion through Week 48.
All-Cause Mortality
Lanraplenib 30 mg Filgotinib 200 mg Placebo Placebo to Lanraplenib 30 mg Placebo to Filgotinib 200 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/17 (0.00%)   0/9 (0.00%)   0/4 (0.00%)   0/4 (0.00%) 
Hide Serious Adverse Events
Lanraplenib 30 mg Filgotinib 200 mg Placebo Placebo to Lanraplenib 30 mg Placebo to Filgotinib 200 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/19 (10.53%)   1/17 (5.88%)   0/9 (0.00%)   0/4 (0.00%)   0/4 (0.00%) 
Cardiac disorders           
Coronary artery occlusion  1  1/19 (5.26%)  0/17 (0.00%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Gastrointestinal disorders           
Haemorrhoids  1  0/19 (0.00%)  1/17 (5.88%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Immune system disorders           
Drug hypersensitivity  1  1/19 (5.26%)  0/17 (0.00%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
1
Term from vocabulary, MedDRA Version 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 30 mg Filgotinib 200 mg Placebo Placebo to Lanraplenib 30 mg Placebo to Filgotinib 200 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   17/19 (89.47%)   11/17 (64.71%)   6/9 (66.67%)   3/4 (75.00%)   3/4 (75.00%) 
Blood and lymphatic system disorders           
Anaemia  1  1/19 (5.26%)  0/17 (0.00%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Lymphopenia  1  1/19 (5.26%)  1/17 (5.88%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Ear and labyrinth disorders           
Vertigo  1  0/19 (0.00%)  1/17 (5.88%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Eye disorders           
Dry eye  1  0/19 (0.00%)  1/17 (5.88%)  0/9 (0.00%)  1/4 (25.00%)  0/4 (0.00%) 
Gastrointestinal disorders           
Abdominal distension  1  1/19 (5.26%)  0/17 (0.00%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Abdominal pain  1  0/19 (0.00%)  1/17 (5.88%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Aphthous ulcer  1  0/19 (0.00%)  0/17 (0.00%)  0/9 (0.00%)  0/4 (0.00%)  1/4 (25.00%) 
Constipation  1  0/19 (0.00%)  1/17 (5.88%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Diarrhoea  1  2/19 (10.53%)  1/17 (5.88%)  0/9 (0.00%)  0/4 (0.00%)  1/4 (25.00%) 
Dry mouth  1  1/19 (5.26%)  0/17 (0.00%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Dyspepsia  1  0/19 (0.00%)  1/17 (5.88%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Flatulence  1  1/19 (5.26%)  0/17 (0.00%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Gastrooesophageal reflux disease  1  1/19 (5.26%)  1/17 (5.88%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Nausea  1  2/19 (10.53%)  3/17 (17.65%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Toothache  1  1/19 (5.26%)  0/17 (0.00%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Vomiting  1  1/19 (5.26%)  2/17 (11.76%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
General disorders           
Chest pain  1  0/19 (0.00%)  0/17 (0.00%)  1/9 (11.11%)  0/4 (0.00%)  0/4 (0.00%) 
Fatigue  1  1/19 (5.26%)  2/17 (11.76%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Non-cardiac chest pain  1  0/19 (0.00%)  1/17 (5.88%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Oedema peripheral  1  0/19 (0.00%)  1/17 (5.88%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Pyrexia  1  0/19 (0.00%)  1/17 (5.88%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Immune system disorders           
Hypersensitivity  1  0/19 (0.00%)  1/17 (5.88%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Seasonal allergy  1  1/19 (5.26%)  0/17 (0.00%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Infections and infestations           
Acne pustular  1  0/19 (0.00%)  1/17 (5.88%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Bronchitis  1  2/19 (10.53%)  0/17 (0.00%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Cystitis  1  0/19 (0.00%)  0/17 (0.00%)  0/9 (0.00%)  0/4 (0.00%)  1/4 (25.00%) 
Gastroenteritis  1  0/19 (0.00%)  1/17 (5.88%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Gastroenteritis viral  1  1/19 (5.26%)  0/17 (0.00%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Herpes zoster  1  1/19 (5.26%)  0/17 (0.00%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Nasopharyngitis  1  1/19 (5.26%)  0/17 (0.00%)  0/9 (0.00%)  1/4 (25.00%)  0/4 (0.00%) 
Oral herpes  1  1/19 (5.26%)  0/17 (0.00%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Osteomyelitis  1  0/19 (0.00%)  1/17 (5.88%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Otitis externa  1  1/19 (5.26%)  0/17 (0.00%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Postoperative wound infection  1  1/19 (5.26%)  0/17 (0.00%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Sinusitis  1  0/19 (0.00%)  2/17 (11.76%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Tonsillitis  1  0/19 (0.00%)  1/17 (5.88%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Upper respiratory tract infection  1  4/19 (21.05%)  3/17 (17.65%)  2/9 (22.22%)  0/4 (0.00%)  0/4 (0.00%) 
Urinary tract infection  1  3/19 (15.79%)  2/17 (11.76%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Viral pharyngitis  1  0/19 (0.00%)  1/17 (5.88%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Vulvovaginal mycotic infection  1  1/19 (5.26%)  1/17 (5.88%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Injury, poisoning and procedural complications           
Corneal abrasion  1  0/19 (0.00%)  0/17 (0.00%)  1/9 (11.11%)  0/4 (0.00%)  0/4 (0.00%) 
Fall  1  0/19 (0.00%)  2/17 (11.76%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Foreign body  1  0/19 (0.00%)  1/17 (5.88%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Tooth fracture  1  0/19 (0.00%)  0/17 (0.00%)  0/9 (0.00%)  1/4 (25.00%)  0/4 (0.00%) 
Investigations           
Alanine aminotransferase increased  1  1/19 (5.26%)  0/17 (0.00%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Aspartate aminotransferase increased  1  1/19 (5.26%)  0/17 (0.00%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Gamma-glutamyltransferase increased  1  1/19 (5.26%)  0/17 (0.00%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Hepatic enzyme increased  1  1/19 (5.26%)  0/17 (0.00%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Liver function test increased  1  1/19 (5.26%)  0/17 (0.00%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Vitamin D decreased  1  1/19 (5.26%)  0/17 (0.00%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Weight increased  1  0/19 (0.00%)  0/17 (0.00%)  1/9 (11.11%)  0/4 (0.00%)  0/4 (0.00%) 
Metabolism and nutrition disorders           
Hyperlipidaemia  1  0/19 (0.00%)  1/17 (5.88%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Iron deficiency  1  0/19 (0.00%)  1/17 (5.88%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Musculoskeletal and connective tissue disorders           
Arthralgia  1  0/19 (0.00%)  1/17 (5.88%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Back pain  1  1/19 (5.26%)  2/17 (11.76%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Joint swelling  1  0/19 (0.00%)  1/17 (5.88%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Muscle spasms  1  0/19 (0.00%)  0/17 (0.00%)  1/9 (11.11%)  0/4 (0.00%)  0/4 (0.00%) 
Musculoskeletal pain  1  1/19 (5.26%)  1/17 (5.88%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Myalgia  1  0/19 (0.00%)  0/17 (0.00%)  0/9 (0.00%)  1/4 (25.00%)  0/4 (0.00%) 
Pain in extremity  1  2/19 (10.53%)  1/17 (5.88%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Skin papilloma  1  0/19 (0.00%)  1/17 (5.88%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Nervous system disorders           
Carpal tunnel syndrome  1  0/19 (0.00%)  1/17 (5.88%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Cognitive disorder  1  0/19 (0.00%)  0/17 (0.00%)  1/9 (11.11%)  0/4 (0.00%)  0/4 (0.00%) 
Headache  1  2/19 (10.53%)  4/17 (23.53%)  0/9 (0.00%)  0/4 (0.00%)  1/4 (25.00%) 
Hypoaesthesia  1  1/19 (5.26%)  0/17 (0.00%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Migraine  1  0/19 (0.00%)  1/17 (5.88%)  1/9 (11.11%)  0/4 (0.00%)  0/4 (0.00%) 
Neuropathy peripheral  1  0/19 (0.00%)  1/17 (5.88%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Paraesthesia  1  1/19 (5.26%)  0/17 (0.00%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Sinus headache  1  0/19 (0.00%)  1/17 (5.88%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Renal and urinary disorders           
Pollakiuria  1  0/19 (0.00%)  1/17 (5.88%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Reproductive system and breast disorders           
Ovarian cyst  1  0/19 (0.00%)  1/17 (5.88%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Pelvic pain  1  0/19 (0.00%)  1/17 (5.88%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Uterine mass  1  0/19 (0.00%)  1/17 (5.88%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Dyspnoea  1  0/19 (0.00%)  0/17 (0.00%)  1/9 (11.11%)  0/4 (0.00%)  0/4 (0.00%) 
Nasal congestion  1  0/19 (0.00%)  0/17 (0.00%)  1/9 (11.11%)  0/4 (0.00%)  0/4 (0.00%) 
Paranasal sinus discomfort  1  0/19 (0.00%)  1/17 (5.88%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Pleurisy  1  1/19 (5.26%)  0/17 (0.00%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Sinus congestion  1  1/19 (5.26%)  2/17 (11.76%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Sinus pain  1  0/19 (0.00%)  1/17 (5.88%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Upper-airway cough syndrome  1  0/19 (0.00%)  1/17 (5.88%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Skin and subcutaneous tissue disorders           
Rash  1  0/19 (0.00%)  1/17 (5.88%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Rash erythematous  1  1/19 (5.26%)  0/17 (0.00%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Rosacea  1  0/19 (0.00%)  0/17 (0.00%)  1/9 (11.11%)  0/4 (0.00%)  0/4 (0.00%) 
Skin lesion  1  0/19 (0.00%)  0/17 (0.00%)  0/9 (0.00%)  1/4 (25.00%)  0/4 (0.00%) 
Urticaria  1  1/19 (5.26%)  0/17 (0.00%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Surgical and medical procedures           
Tooth extraction  1  0/19 (0.00%)  1/17 (5.88%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Vascular disorders           
Haematoma  1  1/19 (5.26%)  0/17 (0.00%)  0/9 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Hypertension  1  0/19 (0.00%)  0/17 (0.00%)  0/9 (0.00%)  0/4 (0.00%)  1/4 (25.00%) 
1
Term from vocabulary, MedDRA Version 22.0
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: NCT03134222    
Other Study ID Numbers: GS-US-436-4092
First Submitted: April 25, 2017
First Posted: April 28, 2017
Results First Submitted: March 9, 2020
Results First Posted: April 8, 2020
Last Update Posted: June 9, 2020