Noninfectious UveitisPhase 2HUMBOLDTNCT03207815
Study to Evaluate the Efficacy and Safety of Filgotinib in Adults With Active Noninfectious Uveitis
A Phase 2 study testing Filgotinib and Prednisone in people with Noninfectious Uveitis, run by Gilead Sciences at 24 sites in 7 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Noninfectious Uveitis
- What is being tested?
- Filgotinib and Prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 24 sitesin 7 countries
- Study dates
- 26 Jul 2017to 22 Apr 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion
- ≥ 2+ anterior chamber cells per the Standardization of Uveitis Nomenclature (SUN) criteria
- ≥ 2+ vitreous haze per the National Eye Institute/Standardization of Uveitis Nomenclature (NEI/SUN) criteria
- No evidence of active tuberculosis (TB) or untreated latent TB
Who cannot join
- Participants with elevated intraocular pressures and/or severe glaucoma
- Confirmed or suspected infectious uveitis, including but not limited to infectious uveitis due to TB, cytomegalovirus (CMV), Human T-Lymphotropic Virus Type 1 (HTLV-1), Whipple's disease, Herpes Zoster virus (HZV), Lyme disease, toxoplasmosis and herpes simplex virus (HSV)
- Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
Trial locations and contacts
24 sites in 7 countries.
24 sites in 7 countries
United States15 sites
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
Northwestern Medical Group
Chicago, Illinois, 60611
Cleveland Clinic Foundation-Cole Eye Institute
Cleveland, Ohio, 44191
Duke University Eye Center
Durham, North Carolina, 27710
Texas Retina Associates - Fort Worth
Fort Worth, Texas, 76104
Colorado Retina Associates PC
Golden, Colorado, 80401
university of Wisconsin-Madison
Madison, Wisconsin, 53705
Illinois Retina Associates
Oak Park, Illinois, 60304
Metropolitan Eye Research and Surgery Institute
Palisades Park, New Jersey, 07650
Stanford Byers Eye Institute
Palo Alto, California, 94303
Mid Atlantic Retina
Philadelphia, Pennsylvania, 19107
Oregon Health Science University-Casey Eye Institute
Portland, Oregon, 97239
Associated Retinal Consultants PC
Royal Oak, Michigan, 48073
Foresight Studies, LLC
San Antonio, Texas, 78240
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
United Kingdom4 sites
Royal Liverpool University Hospital
Liverpool, L7 8XP
Moorfields Eye Hospital NHS Foundation Trust
London
Central Mancester Hospitals NHS Foundation Trust, Manchester Royal Eye Hospital
Manchester, M13 9WL
Eye Research Group Oxford, Oxford Eye Hospital
Oxford, OX3 9DU
About this study
Official title: A Phase 2, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Filgotinib in Subjects With Active Noninfectious Uveitis
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.
- Conditions
- Noninfectious Uveitis
- Being tested
- Filgotinib, Placebo to match filgotinib, Prednisone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FilgotinibDrug
Also called GS-6034, GLPG0634
Tablet(s) administered orally
Placebo to match filgotinibDrug
Tablet(s) administered orally
PrednisoneDrug
Tablet(s) administered orally
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Filgotinib; Drug: Prednisone |
| 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. Receives: Drug: Placebo to match filgotinib; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 6 through Week 24
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 6 through Week 52
Plasma Concentration of Filgotinib
Measured: 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
Measured: Day 1 post dose, Weeks 4 and 6 predose, Week 12 post dose, Weeks 24, 36, 52 (EOT), ET at any time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2017
- Study start26 Jul 2017
- Primary completion29 Dec 2020
- Study completion22 Apr 2021
Why it stopped: Development program terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Noninfectious UveitisStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lakefront Biotherapeutics NV
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03207815
- Sponsor's protocol ID
- GS-US-432-4097
- Other IDs
- 2017-001485-17, 2017
- Acronym
- HUMBOLDT
- Status last verified
- Dec 2021
- First submitted
- 30 Jun 2017
- Last updated
- 21 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39023880Hashida 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.
PubMed 37172783
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Filgotinib in Subjects With Active Noninfectious Uveitis
- ClinicalTrials.gov ID
- NCT03207815
- Acronym / sponsor ID
- HUMBOLDT / GS-US-432-4097
- Conditions
- Noninfectious Uveitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Development program terminated
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Collaborators
- Lakefront Biotherapeutics NV
- Study start
- 26 Jul 2017 (actual)
- Primary completion
- 29 Dec 2020 (actual)
- Study completion
- 22 Apr 2021 (actual)
- First posted
- 5 Jul 2017 (actual)
- Results
- Posted 21 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Filgotinib | Experimental | Drug: Filgotinib, Drug: PrednisoneParticipants 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 | Drug: Placebo to match filgotinib, Drug: PrednisoneParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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 (3 listed)
- Participants with elevated intraocular pressures and/or severe glaucoma
- Confirmed or suspected infectious uveitis, including but not limited to infectious uveitis due to TB, cytomegalovirus (CMV), Human T-Lymphotropic Virus Type 1 (HTLV-1), Whipple's disease, Herpes Zoster virus (HZV), Lyme disease, toxoplasmosis and herpes simplex virus (HSV)
- Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FilgotinibAlso: GS-6034, GLPG0634Tablet(s) administered orally | Drug | Filgotinib |
| Placebo to match filgotinibTablet(s) administered orally | Drug | Placebo |
| PrednisoneTablet(s) administered orally | Drug | Filgotinib, Placebo |
Primary outcome
Percentage of Participants Failing Treatment for Active NonInfectious Uveitis by Week 24
Time frame: 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.
8 secondary outcomes
Time to Treatment Failure on or After Week 6
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 frame: Week 6 through Week 52
Plasma Concentration of Filgotinib
Time frame: 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
Time frame: Day 1 post dose, Weeks 4 and 6 predose, Week 12 post dose, Weeks 24, 36, 52 (EOT), ET at any time
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39023880Srivastava 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.
- Derived from this study: PubMed 37172783Hashida 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.
- Individual participant dataSharing planned: No
Related trials for Noninfectious Uveitis
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A Phase 3 Study of VVN461 Ophthalmic Solution for Noninfectious Anterior Uveitis
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Frequency and Intensity of Inflammatory Relapses in Patients With Non-infectious Posterior Uveitis Treated With a Fluocinolone Acetonide Implant
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilead Study Director study director
Gilead Sciences
24 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Filgotinib and Prednisone in people with Noninfectious Uveitis, run by Gilead Sciences at 24 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, United Kingdom, Australia, Canada, Germany and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Failing Treatment for Active NonInfectious Uveitis by Week 24 (time frame: Week 6 through Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03207815, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2022.