Study to Evaluate the Efficacy and Safety of Filgotinib in Adults With Active Noninfectious Uveitis
NCT ID: NCT03207815
Last Updated: 2022-01-21
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
74 participants
INTERVENTIONAL
2017-07-26
2021-04-22
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Efficacy Study of Gevokizumab to Treat Active Non-infectious Uveitis
NCT01684345
Safety and Efficacy of AIN457 in Patients With Quiescent Non-infectious Uveitis
NCT01032915
Efficacy and Safety Study of Gevokizumab to Treat Behcet's Disease Uveitis
NCT02258867
Use of Simvastatin as a Steroid Sparing Agent for Uveitis Patients
NCT02252328
A Multicenter Phase 2 Single-arm Proof-of-concept Trial to Assess the Efficacy and Safety of Ustekinumab in Association With Prednisone for the Treatment of Non-infectious Severe Uveitis (NISU)
NCT03847272
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Filgotinib
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.
Filgotinib
Tablet(s) administered orally
Prednisone
Tablet(s) administered orally
Placebo
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.
Placebo to match filgotinib
Tablet(s) administered orally
Prednisone
Tablet(s) administered orally
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Filgotinib
Tablet(s) administered orally
Placebo to match filgotinib
Tablet(s) administered orally
Prednisone
Tablet(s) administered orally
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Galapagos NV
INDUSTRY
Gilead Sciences
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Stanford Byers Eye Institute
Palo Alto, California, United States
Colorado Retina Associates PC
Golden, Colorado, United States
Northwestern Medical Group
Chicago, Illinois, United States
Illinois Retina Associates
Oak Park, Illinois, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States
Associated Retinal Consultants PC
Royal Oak, Michigan, United States
Metropolitan Eye Research and Surgery Institute
Palisades Park, New Jersey, United States
Duke University Eye Center
Durham, North Carolina, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
Cleveland Clinic Foundation-Cole Eye Institute
Cleveland, Ohio, United States
Oregon Health Science University-Casey Eye Institute
Portland, Oregon, United States
Mid Atlantic Retina
Philadelphia, Pennsylvania, United States
Texas Retina Associates - Fort Worth
Fort Worth, Texas, United States
Foresight Studies, LLC
San Antonio, Texas, United States
university of Wisconsin-Madison
Madison, Wisconsin, United States
Lions Eye Institute
Nedlands, Western Australia, Australia
Retina Consultants
Vancouver, , Canada
St. Franziskus Hospital
Münster, , Germany
Hadassah Medical Center
Jerusalem, , Israel
Auckland Eye
Remuera, , New Zealand
Royal Liverpool University Hospital
Liverpool, , United Kingdom
Moorfields Eye Hospital NHS Foundation Trust
London, , United Kingdom
Central Mancester Hospitals NHS Foundation Trust, Manchester Royal Eye Hospital
Manchester, , United Kingdom
Eye Research Group Oxford, Oxford Eye Hospital
Oxford, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2017-001485-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-432-4097
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.