Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of Filgotinib in Adults With Active Noninfectious Uveitis (NCT NCT03207815)

NCT ID: NCT03207815

Last Updated: 2022-01-21

Results Overview

Treatment failure was a participant meeting at least 1 of these criteria in at least 1 eye: New active, inflammatory lesions relative to Day 1/Baseline (all visits starting Week (Wk) 6); Inability to achieve ≤Grade 0.5+ (at Wk 6) or 2-step increase (change of Grade 0 to Grade 2+/Grade 0.5+ to Grade 3+) (all visits after Wk 6) relative to best state (RBS) achieved in Anterior Chamber (AC) cell grade (Standardization of Uveitis Nomenclature \[SUN\] criteria)\[AC cell grades range from 0 (0 cells) to 4+ (\>50 cells), higher scores=severe uveitis\]; Inability to achieve ≤Grade 0.5+ (at Wk 6) or 2-step increase (all visits after Wk 6) RBS achieved in Vitreous Haze (VH) grade (National Eye Institute \[NEI\]/SUN criteria)\[VH grades range from 0 (no evident VH) to 4+ (optic nerve head is obscured), higher scores=severe uveitis\]; Worsening of best corrected visual acuity (BCVA) by ≥15 letters RBS achieved (all visits starting Wk 6), measured by an eye chart, fewer correct letters=severe uveitis.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

74 participants

Primary outcome timeframe

Week 6 through Week 24

Results posted on

2022-01-21

Participant Flow

Participants were enrolled at study sites in the United States, the United Kingdom, Canada, Australia, Germany, Israel, and New Zealand. The first participant was screened on 26 July 2017. The last study visit occurred on 22 April 2021.

116 participants were screened.

Participant milestones

Participant milestones
Measure	Filgotinib Participants received filgotinib 200 milligrams (mg) tablet orally, once daily for up to 52 weeks along with a standardized prednisone burst of 60 mg/day at Day 1/Baseline followed by a protocol-defined mandatory taper schedule up to Week 15.	Placebo Participants received placebo to match filgotinib tablet orally, once daily for up to 52 weeks along with a standardized prednisone burst of 60 mg/day at Day 1/Baseline followed by a protocol-defined mandatory taper schedule up to Week 15.
Overall Study STARTED	38	36
Overall Study COMPLETED	30	29
Overall Study NOT COMPLETED	8	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Filgotinib Participants received filgotinib 200 milligrams (mg) tablet orally, once daily for up to 52 weeks along with a standardized prednisone burst of 60 mg/day at Day 1/Baseline followed by a protocol-defined mandatory taper schedule up to Week 15.	Placebo Participants received placebo to match filgotinib tablet orally, once daily for up to 52 weeks along with a standardized prednisone burst of 60 mg/day at Day 1/Baseline followed by a protocol-defined mandatory taper schedule up to Week 15.
Overall Study Protocol Violation	3	1
Overall Study Adverse Event	1	2
Overall Study Lost to Follow-up	1	2
Overall Study Investigator's Discretion	1	1
Overall Study Lack of Efficacy	0	1
Overall Study Pregnancy/Partner Pregnancy	1	0
Overall Study Withdrew Consent	1	0

Baseline Characteristics

Study to Evaluate the Efficacy and Safety of Filgotinib in Adults With Active Noninfectious Uveitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Filgotinib n=37 Participants Participants received filgotinib 200 mg tablet orally, once daily for up to 52 weeks along with a standardized prednisone burst of 60 mg/day at Day 1/Baseline followed by a protocol-defined mandatory taper schedule up to Week 15.	Placebo n=35 Participants Participants received placebo to match filgotinib tablet orally, once daily for up to 52 weeks along with a standardized prednisone burst of 60 mg/day at Day 1/Baseline followed by a protocol-defined mandatory taper schedule up to Week 15.	Total n=72 Participants Total of all reporting groups
Age, Continuous	48 years STANDARD_DEVIATION 15.1 • n=5 Participants	43 years STANDARD_DEVIATION 15.7 • n=7 Participants	46 years STANDARD_DEVIATION 15.5 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	20 Participants n=7 Participants	43 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic or Latino	4 Participants n=5 Participants	10 Participants n=7 Participants	14 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Not Hispanic or Latino	32 Participants n=5 Participants	25 Participants n=7 Participants	57 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Not Permitted	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black or African American	2 Participants n=5 Participants	8 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	29 Participants n=5 Participants	26 Participants n=7 Participants	55 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants	31 participants n=7 Participants	60 participants n=5 Participants
Region of Enrollment United Kingdom	4 participants n=5 Participants	2 participants n=7 Participants	6 participants n=5 Participants
Region of Enrollment Canada	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment Australia	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment Germany	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment Israel	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment New Zealand	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 6 through Week 24

Population: Evaluable Analysis Set included all randomized participants who received at least one dose of study drug and did not permanently discontinue from the study prior to Week 6.

Outcome measures

Outcome measures
Measure	Filgotinib n=32 Participants Participants received filgotinib 200 mg tablet orally, once daily for up to 52 weeks along with a standardized prednisone burst of 60 mg/day at Day 1/Baseline followed by a protocol-defined mandatory taper schedule up to Week 15.	Placebo n=34 Participants Participants received placebo to match filgotinib tablet orally, once daily for up to 52 weeks along with a standardized prednisone burst of 60 mg/day at Day 1/Baseline followed by a protocol-defined mandatory taper schedule up to Week 15.
Percentage of Participants Failing Treatment for Active NonInfectious Uveitis by Week 24	37.5 percentage of participants Interval 19.2 to 55.8	67.6 percentage of participants Interval 50.5 to 84.8

SECONDARY outcome

Timeframe: Week 6 through Week 52

Population: Participants in the Evaluable Analysis Set were analyzed.

Treatment failure was a participant meeting at least 1 of these criteria in at least 1 eye: New active, inflammatory lesions relative to Day 1/Baseline (all visits starting Wk 6); Inability to achieve ≤Grade 0.5+ (at Wk 6) or 2-step increase (change of Grade 0 to Grade 2+/Grade 0.5+ to Grade 3+) (all visits after Wk 6) relative to best state (RBS) achieved in AC cell grade (SUN criteria) \[AC cell grades range from 0 (0 cells) to 4+ (\>50 cells), higher scores=severe uveitis\]; Inability to achieve ≤Grade 0.5+ (at Wk 6) or 2-step increase (all visits after Wk 6) RBS achieved in VH grade (NEI/SUN criteria) \[VH grades range from 0 (no evident VH) to 4+ (optic nerve head is obscured), higher scores=severe uveitis\]; Worsening of BCVA by ≥15 letters RBS achieved (all visits starting Wk 6), measured by an eye chart, fewer correct letters=severe uveitis.

Outcome measures

Outcome measures
Measure	Filgotinib n=32 Participants Participants received filgotinib 200 mg tablet orally, once daily for up to 52 weeks along with a standardized prednisone burst of 60 mg/day at Day 1/Baseline followed by a protocol-defined mandatory taper schedule up to Week 15.	Placebo n=34 Participants Participants received placebo to match filgotinib tablet orally, once daily for up to 52 weeks along with a standardized prednisone burst of 60 mg/day at Day 1/Baseline followed by a protocol-defined mandatory taper schedule up to Week 15.
Time to Treatment Failure on or After Week 6	NA weeks Interval 24.1 to Not Available as the calculated percentiles of event rate were not reached.	22.0 weeks Interval 12.1 to 47.0

SECONDARY outcome

Timeframe: Prior to Week 6; Up to Week 52 or EOT or ET (maximum: 53 weeks)

Population: Participants in the Evaluable Analysis Set with available data were analyzed.

Grading of VH was based on the publication from the NEI which has also been adapted by the SUN working group. VH grades range from 0 (no evident VH) to 4+ (optic nerve head is obscured), with higher scores indicating greater severity of uveitis. A negative change from best state value obtained prior to Week 6 indicates improvement.

Outcome measures

Outcome measures
Measure	Filgotinib n=32 Participants Participants received filgotinib 200 mg tablet orally, once daily for up to 52 weeks along with a standardized prednisone burst of 60 mg/day at Day 1/Baseline followed by a protocol-defined mandatory taper schedule up to Week 15.	Placebo n=34 Participants Participants received placebo to match filgotinib tablet orally, once daily for up to 52 weeks along with a standardized prednisone burst of 60 mg/day at Day 1/Baseline followed by a protocol-defined mandatory taper schedule up to Week 15.
Change in Vitreous Haze (VH) Grade in Each Eye (NEI/SUN Criteria), From Best State Achieved Prior to Week 6 to Week 52 or End of Treatment (EOT) Visit or Early Termination (ET) Left Eye: Best State Prior to Week 6	0.3 score Standard Deviation 0.40	0.2 score Standard Deviation 0.33
Change in Vitreous Haze (VH) Grade in Each Eye (NEI/SUN Criteria), From Best State Achieved Prior to Week 6 to Week 52 or End of Treatment (EOT) Visit or Early Termination (ET) Right Eye: Best State Prior to Week 6	0.3 score Standard Deviation 0.36	0.3 score Standard Deviation 0.45
Change in Vitreous Haze (VH) Grade in Each Eye (NEI/SUN Criteria), From Best State Achieved Prior to Week 6 to Week 52 or End of Treatment (EOT) Visit or Early Termination (ET) Left Eye: Change From Best State at Week 52/EOT/ET	0.1 score Standard Deviation 0.79	0.3 score Standard Deviation 0.75
Change in Vitreous Haze (VH) Grade in Each Eye (NEI/SUN Criteria), From Best State Achieved Prior to Week 6 to Week 52 or End of Treatment (EOT) Visit or Early Termination (ET) Right Eye: Change From Best State at Week 52/EOT/ET	0.1 score Standard Deviation 0.62	0.2 score Standard Deviation 0.66

SECONDARY outcome

Timeframe: Prior to Week 6; Up to Week 52 or EOT or ET (maximum: 53 weeks)

Population: Participants in the Evaluable Analysis Set were analyzed.

The number of AC cells observed within a 1 mm × 1 mm slit beam were recorded for each eye. The reported number was used to determine the grade according to the SUN criteria. AC cell grades range from 0 (0 cells in field) to 4+ (\>50 cells in field), with higher scores indicating more cells visible in the AC and greater severity of uveitis. A negative change from best state value obtained prior to Week 6 indicates improvement.

Outcome measures

Outcome measures
Measure	Filgotinib n=32 Participants Participants received filgotinib 200 mg tablet orally, once daily for up to 52 weeks along with a standardized prednisone burst of 60 mg/day at Day 1/Baseline followed by a protocol-defined mandatory taper schedule up to Week 15.	Placebo n=34 Participants Participants received placebo to match filgotinib tablet orally, once daily for up to 52 weeks along with a standardized prednisone burst of 60 mg/day at Day 1/Baseline followed by a protocol-defined mandatory taper schedule up to Week 15.
Change in Anterior Chamber (AC) Cell Grade in Each Eye, From Best State Achieved Prior to Week 6 to Week 52 or EOT Visit or ET Left Eye: Best State Prior to Week 6	0.0 score Standard Deviation 0.09	0.1 score Standard Deviation 0.19
Change in Anterior Chamber (AC) Cell Grade in Each Eye, From Best State Achieved Prior to Week 6 to Week 52 or EOT Visit or ET Right Eye: Best State Prior to Week 6	0.0 score Standard Deviation 0.12	0.1 score Standard Deviation 0.25
Change in Anterior Chamber (AC) Cell Grade in Each Eye, From Best State Achieved Prior to Week 6 to Week 52 or EOT Visit or ET Left Eye: Change From Best State at Week 52/EOT/ET	0.2 score Standard Deviation 0.59	0.6 score Standard Deviation 0.87
Change in Anterior Chamber (AC) Cell Grade in Each Eye, From Best State Achieved Prior to Week 6 to Week 52 or EOT Visit or ET Right Eye: Change From Best State at Week 52/EOT/ET	0.2 score Standard Deviation 0.53	0.7 score Standard Deviation 1.05

SECONDARY outcome

Timeframe: Prior to Week 6; Up to Week 52 or EOT or ET (maximum: 53 weeks)

Population: Participants in the Evaluable Analysis Set were analyzed.

BCVA is the best possible vision that an eye can achieve with the set of glasses or contact lenses. A refraction test was performed to measure the appropriate lens strength to focus light on the retina. Using the appropriate corrective lenses based on that visit's refraction, participant's BCVA was measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. In the ETDRS system, 15 letters is equal to a change in 3 lines of visual acuity. If the participant is unable to read letters on a testing chart, visual acuity is described as ranging from ability to count fingers, recognize hand movements, or light perception. The smaller BVCA score indicates greater severity of uveitis. A positive change from best state value obtained prior to Week 6 indicates improvement.

Outcome measures

Outcome measures
Measure	Filgotinib n=32 Participants Participants received filgotinib 200 mg tablet orally, once daily for up to 52 weeks along with a standardized prednisone burst of 60 mg/day at Day 1/Baseline followed by a protocol-defined mandatory taper schedule up to Week 15.	Placebo n=34 Participants Participants received placebo to match filgotinib tablet orally, once daily for up to 52 weeks along with a standardized prednisone burst of 60 mg/day at Day 1/Baseline followed by a protocol-defined mandatory taper schedule up to Week 15.
Change in Logarithm of the Minimal Angle of Resolution (logMAR) Best Corrected Visual Acuity (BCVA) in Each Eye, From Best State Achieved Prior to Week 6 to Week 52 or EOT Visit or ET Left Eye: Best State Prior to Week 6	0.09 logMAR Standard Deviation 0.195	0.07 logMAR Standard Deviation 0.209
Change in Logarithm of the Minimal Angle of Resolution (logMAR) Best Corrected Visual Acuity (BCVA) in Each Eye, From Best State Achieved Prior to Week 6 to Week 52 or EOT Visit or ET Right Eye: Best State Prior to Week 6	0.09 logMAR Standard Deviation 0.193	0.12 logMAR Standard Deviation 0.280
Change in Logarithm of the Minimal Angle of Resolution (logMAR) Best Corrected Visual Acuity (BCVA) in Each Eye, From Best State Achieved Prior to Week 6 to Week 52 or EOT Visit or ET Left Eye: Change From Best State at Week 52/EOT/ET	0.03 logMAR Standard Deviation 0.154	0.05 logMAR Standard Deviation 0.112
Change in Logarithm of the Minimal Angle of Resolution (logMAR) Best Corrected Visual Acuity (BCVA) in Each Eye, From Best State Achieved Prior to Week 6 to Week 52 or EOT Visit or ET Right Eye: Change From Best State at Week 52/EOT/ET	-0.01 logMAR Standard Deviation 0.116	0.07 logMAR Standard Deviation 0.144

SECONDARY outcome

Timeframe: Prior to Week 6; Up to Week 52 or EOT or ET (maximum: 53 weeks)

Population: Participants in the Evaluable Analysis Set with the available data were analyzed.

Central retinal thickness is measured by optical coherence tomography (OCT). Central retinal thickness is defined as the thickness of the retina in the center of the foveal pit (1 mm subfield). The larger central retinal thickness value indicates greater severity of uveitis. A negative change from best state value obtained prior to Week 6 indicates improvement.

Outcome measures

Outcome measures
Measure	Filgotinib n=32 Participants Participants received filgotinib 200 mg tablet orally, once daily for up to 52 weeks along with a standardized prednisone burst of 60 mg/day at Day 1/Baseline followed by a protocol-defined mandatory taper schedule up to Week 15.	Placebo n=34 Participants Participants received placebo to match filgotinib tablet orally, once daily for up to 52 weeks along with a standardized prednisone burst of 60 mg/day at Day 1/Baseline followed by a protocol-defined mandatory taper schedule up to Week 15.
Log Change in Central Retinal Thickness in Each Eye, From Best State Achieved Prior to Week 6 to Week 52 or EOT Visit or ET Left Eye: Best State Prior to Week 6	2.45 log microns Standard Deviation 0.059	2.46 log microns Standard Deviation 0.097
Log Change in Central Retinal Thickness in Each Eye, From Best State Achieved Prior to Week 6 to Week 52 or EOT Visit or ET Right Eye: Best State Prior to Week 6	2.47 log microns Standard Deviation 0.056	2.44 log microns Standard Deviation 0.104
Log Change in Central Retinal Thickness in Each Eye, From Best State Achieved Prior to Week 6 to Week 52 or EOT Visit or ET Left Eye: Change From Best State at Week 52/EOT/ET	0.01 log microns Standard Deviation 0.062	0.04 log microns Standard Deviation 0.080
Log Change in Central Retinal Thickness in Each Eye, From Best State Achieved Prior to Week 6 to Week 52 or EOT Visit or ET Right Eye: Change From Best State at Week 52/EOT/ET	0.01 log microns Standard Deviation 0.049	0.03 log microns Standard Deviation 0.055

SECONDARY outcome

Timeframe: Week 6 through Week 52

Population: Participants in the Evaluable Analysis Set were analyzed.

Time in weeks until the development of Macular edema or Week 52 or EOT or ET. Macular edema is determined by OCT and is defined as central retinal thickness ≥ 300 microns if using Cirrus machine, or ≥ 315 microns if using Spectralis machine.

Outcome measures

Outcome measures
Measure	Filgotinib n=32 Participants Participants received filgotinib 200 mg tablet orally, once daily for up to 52 weeks along with a standardized prednisone burst of 60 mg/day at Day 1/Baseline followed by a protocol-defined mandatory taper schedule up to Week 15.	Placebo n=34 Participants Participants received placebo to match filgotinib tablet orally, once daily for up to 52 weeks along with a standardized prednisone burst of 60 mg/day at Day 1/Baseline followed by a protocol-defined mandatory taper schedule up to Week 15.
Time to Development of Macular Edema in At Least One Eye on or After Week 6	7.8 weeks Interval 6.1 to Not Available as the calculated percentiles of event rate were not reached.	12.3 weeks Interval 6.1 to Not Available as the calculated percentiles of event rate were not reached.

SECONDARY outcome

Timeframe: Day 1 post dose, Weeks 4 and 6 predose, Week 12 post dose, Weeks 24, 36, 52 (EOT), ET at any time

Population: Participants in the Safety Analysis Set who have at least one non-missing concentration data with available data were analyzed.

Outcome measures

Outcome measures
Measure	Filgotinib n=37 Participants Participants received filgotinib 200 mg tablet orally, once daily for up to 52 weeks along with a standardized prednisone burst of 60 mg/day at Day 1/Baseline followed by a protocol-defined mandatory taper schedule up to Week 15.	Placebo Participants received placebo to match filgotinib tablet orally, once daily for up to 52 weeks along with a standardized prednisone burst of 60 mg/day at Day 1/Baseline followed by a protocol-defined mandatory taper schedule up to Week 15.
Plasma Concentration of Filgotinib Week 36 Single Anytime	295.7 nanograms per millilitre (ng/ml) Standard Deviation 420.25	—
Plasma Concentration of Filgotinib Day 1 Postdose	748.5 nanograms per millilitre (ng/ml) Standard Deviation 1043.84	—
Plasma Concentration of Filgotinib Week 4 Predose	173.3 nanograms per millilitre (ng/ml) Standard Deviation 364.46	—
Plasma Concentration of Filgotinib Week 6 Predose	133.9 nanograms per millilitre (ng/ml) Standard Deviation 306.18	—
Plasma Concentration of Filgotinib Week 12 Postdose	1088.7 nanograms per millilitre (ng/ml) Standard Deviation 856.57	—
Plasma Concentration of Filgotinib Week 24 Single Anytime	397.5 nanograms per millilitre (ng/ml) Standard Deviation 561.57	—
Plasma Concentration of Filgotinib Week 52 Single Anytime	195.2 nanograms per millilitre (ng/ml) Standard Deviation 344.54	—
Plasma Concentration of Filgotinib Early Termination Single Anytime	434.8 nanograms per millilitre (ng/ml) Standard Deviation 478.72	—

SECONDARY outcome

Timeframe: Day 1 post dose, Weeks 4 and 6 predose, Week 12 post dose, Weeks 24, 36, 52 (EOT), ET at any time

Population: Participants in the Safety Analysis Set who have at least one non-missing concentration data with available data were analyzed.

Outcome measures

Outcome measures
Measure	Filgotinib n=37 Participants Participants received filgotinib 200 mg tablet orally, once daily for up to 52 weeks along with a standardized prednisone burst of 60 mg/day at Day 1/Baseline followed by a protocol-defined mandatory taper schedule up to Week 15.	Placebo Participants received placebo to match filgotinib tablet orally, once daily for up to 52 weeks along with a standardized prednisone burst of 60 mg/day at Day 1/Baseline followed by a protocol-defined mandatory taper schedule up to Week 15.
Plasma Concentration of Metabolite, GS-829845 Day 1 Postdose	230.8 ng/ml Standard Deviation 317.98	—
Plasma Concentration of Metabolite, GS-829845 Week 4 Predose	2085.6 ng/ml Standard Deviation 924.91	—
Plasma Concentration of Metabolite, GS-829845 Week 6 Predose	2107.7 ng/ml Standard Deviation 749.28	—
Plasma Concentration of Metabolite, GS-829845 Week 12 Postdose	3237.0 ng/ml Standard Deviation 1180.74	—
Plasma Concentration of Metabolite, GS-829845 Week 24 Single Anytime	3478.1 ng/ml Standard Deviation 1137.63	—
Plasma Concentration of Metabolite, GS-829845 Week 36 Single Anytime	2944.3 ng/ml Standard Deviation 1130.84	—
Plasma Concentration of Metabolite, GS-829845 Week 52 Single Anytime	2510.7 ng/ml Standard Deviation 1732.59	—
Plasma Concentration of Metabolite, GS-829845 Early Termination Single Anytime	2171.0 ng/ml Standard Deviation 1224.77	—

Adverse Events

Filgotinib

Serious events: 5 serious events

Other events: 28 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Filgotinib n=37 participants at risk Participants received filgotinib 200 mg tablet orally, once daily for up to 52 weeks along with a standardized prednisone burst of 60 mg/day at Day 1/Baseline followed by a protocol-defined mandatory taper schedule up to Week 15.	Placebo n=35 participants at risk Participants received placebo to match filgotinib tablet orally, once daily for up to 52 weeks along with a standardized prednisone burst of 60 mg/day at Day 1/Baseline followed by a protocol-defined mandatory taper schedule up to Week 15.
Eye disorders Retinal vasculitis	0.00% 0/37 • Adverse Events: First dose date up to 30 days after the last dose of study drug (maximum exposure up to 57 weeks); All-Cause Mortality: From randomization up to 57 weeks Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	2.9% 1/35 • Adverse Events: First dose date up to 30 days after the last dose of study drug (maximum exposure up to 57 weeks); All-Cause Mortality: From randomization up to 57 weeks Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Eye disorders Uveitis	2.7% 1/37 • Adverse Events: First dose date up to 30 days after the last dose of study drug (maximum exposure up to 57 weeks); All-Cause Mortality: From randomization up to 57 weeks Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/35 • Adverse Events: First dose date up to 30 days after the last dose of study drug (maximum exposure up to 57 weeks); All-Cause Mortality: From randomization up to 57 weeks Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Gastrointestinal disorders Inflammatory bowel disease	2.7% 1/37 • Adverse Events: First dose date up to 30 days after the last dose of study drug (maximum exposure up to 57 weeks); All-Cause Mortality: From randomization up to 57 weeks Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/35 • Adverse Events: First dose date up to 30 days after the last dose of study drug (maximum exposure up to 57 weeks); All-Cause Mortality: From randomization up to 57 weeks Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Infections and infestations Covid-19	2.7% 1/37 • Adverse Events: First dose date up to 30 days after the last dose of study drug (maximum exposure up to 57 weeks); All-Cause Mortality: From randomization up to 57 weeks Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/35 • Adverse Events: First dose date up to 30 days after the last dose of study drug (maximum exposure up to 57 weeks); All-Cause Mortality: From randomization up to 57 weeks Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Infections and infestations Urinary tract infection	0.00% 0/37 • Adverse Events: First dose date up to 30 days after the last dose of study drug (maximum exposure up to 57 weeks); All-Cause Mortality: From randomization up to 57 weeks Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	2.9% 1/35 • Adverse Events: First dose date up to 30 days after the last dose of study drug (maximum exposure up to 57 weeks); All-Cause Mortality: From randomization up to 57 weeks Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Musculoskeletal and connective tissue disorders Spinal stenosis	2.7% 1/37 • Adverse Events: First dose date up to 30 days after the last dose of study drug (maximum exposure up to 57 weeks); All-Cause Mortality: From randomization up to 57 weeks Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/35 • Adverse Events: First dose date up to 30 days after the last dose of study drug (maximum exposure up to 57 weeks); All-Cause Mortality: From randomization up to 57 weeks Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Nervous system disorders Epilepsy	2.7% 1/37 • Adverse Events: First dose date up to 30 days after the last dose of study drug (maximum exposure up to 57 weeks); All-Cause Mortality: From randomization up to 57 weeks Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/35 • Adverse Events: First dose date up to 30 days after the last dose of study drug (maximum exposure up to 57 weeks); All-Cause Mortality: From randomization up to 57 weeks Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Psychiatric disorders Suicidal ideation	2.7% 1/37 • Adverse Events: First dose date up to 30 days after the last dose of study drug (maximum exposure up to 57 weeks); All-Cause Mortality: From randomization up to 57 weeks Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/35 • Adverse Events: First dose date up to 30 days after the last dose of study drug (maximum exposure up to 57 weeks); All-Cause Mortality: From randomization up to 57 weeks Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.
Renal and urinary disorders Bladder prolapse	2.7% 1/37 • Adverse Events: First dose date up to 30 days after the last dose of study drug (maximum exposure up to 57 weeks); All-Cause Mortality: From randomization up to 57 weeks Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.	0.00% 0/35 • Adverse Events: First dose date up to 30 days after the last dose of study drug (maximum exposure up to 57 weeks); All-Cause Mortality: From randomization up to 57 weeks Adverse Events: Safety Analysis Set included all participants who received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study.

Other adverse events

Additional Information

Gilead Clinical Study Information Center

Gilead Sciences

Phone: 1-833-445-3230 (GILEAD-0)

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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
Publication restrictions are in place

Restriction type: OTHER