Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2017-001485-17 | EudraCT Number |
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Development program terminated
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| Name | Class |
|---|---|
| Lakefront Biotherapeutics NV | INDUSTRY |
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The primary objective of this study is to evaluate the efficacy of filgotinib versus placebo for the treatment of the signs and symptoms of noninfectious uveitis as measured by the percentage of participants failing treatment for active noninfectious uveitis by Week 24.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Filgotinib | Experimental | Participants will receive filgotinib 200 milligrams (mg) once daily for up to 52 weeks along with a standardized prednisone burst of 60 milligrams per day (mg/day) at Day 1/Baseline followed by a protocol-defined mandatory taper schedule up to Week 15. |
|
| Placebo | Placebo Comparator | Participants will receive placebo to match filgotinib 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Filgotinib | Drug | Tablet(s) administered orally |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Failing Treatment for Active NonInfectious Uveitis by Week 24 | 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. | Week 6 through Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Treatment Failure on or After Week 6 | 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. |
Not provided
Key Inclusion Criteria:
Is diagnosed with active noninfectious intermediate-, posterior-, or pan-uveitis
Must have active uveitic disease at the Day 1/Baseline visit as defined by the presence of at least 1 of the following parameters in at least one eye despite 2 weeks of maintenance therapy with oral prednisone (≥ 10 mg/day to ≤ 60 mg/day) or an oral corticosteroid equivalent:
No evidence of active tuberculosis (TB) or untreated latent TB
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Byers Eye Institute | Palo Alto | California | 94303 | United States | ||
| Colorado Retina Associates PC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39023880 | Derived | Srivastava SK, Watkins TR, Nguyen QD, Sharma S, Scales DK, Dacey MS, Shah RE, Chu DS, Grewal DS, Faia LJ, Suhler EB, Genovese MC, Guo Y, Barchuk WT, Besuyen R, Dick AD, Rosenbaum JT. Filgotinib in Active Noninfectious Uveitis: The HUMBOLDT Randomized Clinical Trial. JAMA Ophthalmol. 2024 Sep 1;142(9):789-797. doi: 10.1001/jamaophthalmol.2024.2439. | |
| 37172783 |
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116 participants were screened.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 17, 2020 | Nov 11, 2021 |
Not provided
Not provided
Not provided
Not provided
| Placebo to match filgotinib | Drug | Tablet(s) administered orally |
|
| Prednisone | Drug | Tablet(s) administered orally |
|
| Week 6 through Week 52 |
| 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) | 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. | Prior to Week 6; Up to Week 52 or EOT or ET (maximum: 53 weeks) |
| 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 | 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. | Prior to Week 6; Up to Week 52 or EOT or ET (maximum: 53 weeks) |
| 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 | 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. | Prior to Week 6; Up to Week 52 or EOT or ET (maximum: 53 weeks) |
| 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 | 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. | Prior to Week 6; Up to Week 52 or EOT or ET (maximum: 53 weeks) |
| Time to Development of Macular Edema in At Least One Eye on or After Week 6 | 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. | Week 6 through Week 52 |
| Plasma Concentration of Filgotinib | Day 1 post dose, Weeks 4 and 6 predose, Week 12 post dose, Weeks 24, 36, 52 (EOT), ET at any time |
| Plasma Concentration of Metabolite, GS-829845 | Day 1 post dose, Weeks 4 and 6 predose, Week 12 post dose, Weeks 24, 36, 52 (EOT), ET at any time |
| Golden |
| Colorado |
| 80401 |
| United States |
| Northwestern Medical Group | Chicago | Illinois | 60611 | United States |
| Illinois Retina Associates | Oak Park | Illinois | 60304 | United States |
| Ophthalmic Consultants of Boston | Boston | Massachusetts | 02114 | United States |
| Associated Retinal Consultants PC | Royal Oak | Michigan | 48073 | United States |
| Metropolitan Eye Research and Surgery Institute | Palisades Park | New Jersey | 07650 | United States |
| Duke University Eye Center | Durham | North Carolina | 27710 | United States |
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| Cleveland Clinic Foundation-Cole Eye Institute | Cleveland | Ohio | 44191 | United States |
| Oregon Health Science University-Casey Eye Institute | Portland | Oregon | 97239 | United States |
| Mid Atlantic Retina | Philadelphia | Pennsylvania | 19107 | United States |
| Texas Retina Associates - Fort Worth | Fort Worth | Texas | 76104 | United States |
| Foresight Studies, LLC | San Antonio | Texas | 78240 | United States |
| university of Wisconsin-Madison | Madison | Wisconsin | 53705 | United States |
| Lions Eye Institute | Nedlands | Western Australia | 6009 | Australia |
| Retina Consultants | Vancouver | V5Z 0E9 | Canada |
| St. Franziskus Hospital | Münster | Germany |
| Hadassah Medical Center | Jerusalem | 91120 | Israel |
| Auckland Eye | Remuera | 1050 | New Zealand |
| Royal Liverpool University Hospital | Liverpool | L7 8XP | United Kingdom |
| Moorfields Eye Hospital NHS Foundation Trust | London | United Kingdom |
| Central Mancester Hospitals NHS Foundation Trust, Manchester Royal Eye Hospital | Manchester | M13 9WL | United Kingdom |
| Eye Research Group Oxford, Oxford Eye Hospital | Oxford | OX3 9DU | United Kingdom |
| Hashida N, Nishida K. Recent advances and future prospects: Current status and challenges of the intraocular injection of drugs for vitreoretinal diseases. Adv Drug Deliv Rev. 2023 Jul;198:114870. doi: 10.1016/j.addr.2023.114870. Epub 2023 May 10. |
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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Analysis Set included all participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Filgotinib | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Not Permitted = local regulators did not allow collection of ethnicity information. | Count of Participants | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Failing Treatment for Active NonInfectious Uveitis by Week 24 | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 6 through Week 24 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Treatment Failure on or After Week 6 | 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. | Participants in the Evaluable Analysis Set were analyzed. | Posted | Median | Inter-Quartile Range | weeks | Week 6 through Week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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) | 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. | Participants in the Evaluable Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | score | Prior to Week 6; Up to Week 52 or EOT or ET (maximum: 53 weeks) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | 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. | Participants in the Evaluable Analysis Set were analyzed. | Posted | Mean | Standard Deviation | score | Prior to Week 6; Up to Week 52 or EOT or ET (maximum: 53 weeks) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | 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. | Participants in the Evaluable Analysis Set were analyzed. | Posted | Mean | Standard Deviation | logMAR | Prior to Week 6; Up to Week 52 or EOT or ET (maximum: 53 weeks) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | 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. | Participants in the Evaluable Analysis Set with the available data were analyzed. | Posted | Mean | Standard Deviation | log microns | Prior to Week 6; Up to Week 52 or EOT or ET (maximum: 53 weeks) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Development of Macular Edema in At Least One Eye on or After Week 6 | 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. | Participants in the Evaluable Analysis Set were analyzed. | Posted | Median | Inter-Quartile Range | weeks | Week 6 through Week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Plasma Concentration of Filgotinib | Participants in the Safety Analysis Set who have at least one non-missing concentration data with available data were analyzed. | Posted | Mean | Standard Deviation | nanograms per millilitre (ng/ml) | Day 1 post dose, Weeks 4 and 6 predose, Week 12 post dose, Weeks 24, 36, 52 (EOT), ET at any time |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Plasma Concentration of Metabolite, GS-829845 | Participants in the Safety Analysis Set who have at least one non-missing concentration data with available data were analyzed. | Posted | Mean | Standard Deviation | ng/ml | Day 1 post dose, Weeks 4 and 6 predose, Week 12 post dose, Weeks 24, 36, 52 (EOT), ET at any time |
|
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Filgotinib | 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. | 0 | 38 | 5 | 37 | 28 | 37 |
| EG001 | 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. | 0 | 36 | 2 | 35 | 19 | 35 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retinal vasculitis | Eye disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Uveitis | Eye disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Inflammatory bowel disease | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Bladder prolapse | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anterior chamber inflammation | Eye disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Chalazion | Eye disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Chorioretinal disorder | Eye disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Macular oedema | Eye disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Photopsia | Eye disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Uveitis | Eye disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Vitreous floaters | Eye disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Vitreous haze | Eye disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
|
Study was terminated early due to termination of the development program. Due to early termination and small sample size, pharmacokinetic (PK) analysis was not performed for this study.
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:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 6, 2021 | Nov 11, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| C584571 | GLPG0634 |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Not Permitted |
|
| Black or African American |
|
| Native Hawaiian or Pacific Islander |
|
| White |
|
| Other |
|
| United Kingdom |
|
| Canada |
|
| Australia |
|
| Germany |
|
| Israel |
|
| New Zealand |
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
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