Trial · NCT03207815
Study to Evaluate the Efficacy and Safety of Filgotinib in Adults With Active Noninfectious Uveitis
NCT03207815, Phase 2, Terminated, Gilead Sciences; results first posted 2022-01-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate the Efficacy and Safety of Filgotinib in Adults With Active Noninfectious Uveitis. Trials, record NCT03207815. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03207815
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Efficacy and Safety of Filgotinib in Adults With Active Noninfectious Uveitis
- NCT number
- NCT03207815
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 74 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- Noninfectious Uveitis
- Interventions
- Filgotinib, Placebo to match filgotinib, Prednisone
- First posted
- 2017-07-05
- Last updated
- 2022-01-21
- Other registries' IDs
- eudract:2017-001485-17
- Results first posted
- 2022-01-21
- Limitations and caveats
- 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.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Failing Treatment for Active NonInfectious Uveitis by Week 24 | Week 6 through 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. |
| Secondary | Time to Treatment Failure on or After Week 6 | Week 6 through Week 52 | 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. |
| 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) | Prior to Week 6; Up to Week 52 or EOT or ET (maximum: 53 weeks) | 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. |
| 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 | Prior to Week 6; Up to Week 52 or EOT or ET (maximum: 53 weeks) | 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. |
| 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 | Prior to Week 6; Up to Week 52 or EOT or ET (maximum: 53 weeks) | 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. |
| 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 | Prior to Week 6; Up to Week 52 or EOT or ET (maximum: 53 weeks) | 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. |
| Secondary | Time to Development of Macular Edema in At Least One Eye on or After Week 6 | Week 6 through Week 52 | 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. |
| Secondary | 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 | |
| Secondary | 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 |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Failing Treatment for Active NonInfectious Uveitis by Week 24 | Week 6 through Week 24 | 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. | percentage of participants | NUMBER |
| SECONDARY | Time to Treatment Failure on or After Week 6 | Week 6 through Week 52 | Participants in the Evaluable Analysis Set were analyzed. | weeks | MEDIAN |
| 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) | Prior to Week 6; Up to Week 52 or EOT or ET (maximum: 53 weeks) | Participants in the Evaluable Analysis Set with available data were analyzed. | score | MEAN |
| 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 | Prior to Week 6; Up to Week 52 or EOT or ET (maximum: 53 weeks) | Participants in the Evaluable Analysis Set were analyzed. | score | MEAN |
| 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 | Prior to Week 6; Up to Week 52 or EOT or ET (maximum: 53 weeks) | Participants in the Evaluable Analysis Set were analyzed. | logMAR | MEAN |
| 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 | Prior to Week 6; Up to Week 52 or EOT or ET (maximum: 53 weeks) | Participants in the Evaluable Analysis Set with the available data were analyzed. | log microns | MEAN |
| SECONDARY | Time to Development of Macular Edema in At Least One Eye on or After Week 6 | Week 6 through Week 52 | Participants in the Evaluable Analysis Set were analyzed. | weeks | MEDIAN |
| SECONDARY | 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 | Participants in the Safety Analysis Set who have at least one non-missing concentration data with available data were analyzed. | nanograms per millilitre (ng/ml) | MEAN |
| SECONDARY | 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 | Participants in the Safety Analysis Set who have at least one non-missing concentration data with available data were analyzed. | ng/ml | MEAN |
Source ClinicalTrials.gov
Results by group54
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Failing Treatment for Active NonInfectious Uveitis by Week 24 | Filgotinib | 37.5 | 95% Confidence Interval 19.2 to 55.8 | percentage of participants | |
| Percentage of Participants Failing Treatment for Active NonInfectious Uveitis by Week 24 | Placebo | 67.6 | 95% Confidence Interval 50.5 to 84.8 | percentage of participants | |
| Time to Treatment Failure on or After Week 6 | Filgotinib | NA | Inter-Quartile Range 24.1 to NA | weeks | |
| Time to Treatment Failure on or After Week 6 | Placebo | 22.0 | Inter-Quartile Range 12.1 to 47.0 | weeks | |
| 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) | Filgotinib | Left Eye: Best State Prior to Week 6 | 0.3 | Standard Deviation 0.40 | score |
| 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) | Placebo | Left Eye: Best State Prior to Week 6 | 0.2 | Standard Deviation 0.33 | score |
| 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) | Filgotinib | Right Eye: Best State Prior to Week 6 | 0.3 | Standard Deviation 0.36 | score |
| 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) | Placebo | Right Eye: Best State Prior to Week 6 | 0.3 | Standard Deviation 0.45 | score |
| 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) | Filgotinib | Left Eye: Change From Best State at Week 52/EOT/ET | 0.1 | Standard Deviation 0.79 | score |
| 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) | Placebo | Left Eye: Change From Best State at Week 52/EOT/ET | 0.3 | Standard Deviation 0.75 | score |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Filgotinib | 38 | |
| Overall Study | STARTED | Placebo | 36 | |
| Overall Study | COMPLETED | Filgotinib | 30 | |
| Overall Study | COMPLETED | Placebo | 29 | |
| Overall Study | NOT COMPLETED | Filgotinib | 8 | |
| Overall Study | NOT COMPLETED | Placebo | 7 |
Source ClinicalTrials.gov
Adverse events106
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anterior chamber inflammation | Eye disorders | Filgotinib | 1 | 37 | |
| other | Anterior chamber inflammation | Eye disorders | Placebo | 2 | 35 | |
| other | Cataract | Eye disorders | Filgotinib | 2 | 37 | |
| other | Cataract | Eye disorders | Placebo | 1 | 35 | |
| other | Chalazion | Eye disorders | Filgotinib | 0 | 37 | |
| other | Chalazion | Eye disorders | Placebo | 2 | 35 | |
| other | Chorioretinal disorder | Eye disorders | Filgotinib | 2 | 37 | |
| other | Chorioretinal disorder | Eye disorders | Placebo | 2 | 35 | |
| other | Dry eye | Eye disorders | Filgotinib | 2 | 37 | |
| other | Dry eye | Eye disorders | Placebo | 4 | 35 |
1 to 10 of 106Source ClinicalTrials.gov
See all 106 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Filgotinib | 0 | 38 |
| Total, all-cause mortality | Placebo | 0 | 36 |
| Total, other adverse events | Filgotinib | 28 | 37 |
| Total, other adverse events | Placebo | 19 | 35 |
| Total, serious adverse events | Filgotinib | 5 | 37 |
| Total, serious adverse events | Placebo | 2 | 35 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Filgotinib vs Placebo: deaths from any cause | Trial comparisons |
| Filgotinib vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT03207815/results?page=2