Efficacy and Safety of Filgotinib in Adults With Active Noninfectious Uveitis (Humboldt)
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ClinicalTrials.gov Identifier: NCT03207815 |
Recruitment Status :
Active, not recruiting
First Posted : July 5, 2017
Last Update Posted : January 13, 2021
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Tracking Information | |||||
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First Submitted Date ICMJE | June 30, 2017 | ||||
First Posted Date ICMJE | July 5, 2017 | ||||
Last Update Posted Date | January 13, 2021 | ||||
Actual Study Start Date ICMJE | July 26, 2017 | ||||
Actual Primary Completion Date | December 29, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Proportion of Participants Failing Treatment for Active NonInfectious Uveitis by Week 24 [ Time Frame: Baseline to Week 24 ] Treatment failure will be defined as a participant meeting at least one of the following criteria in at least one eye:
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Original Primary Outcome Measures ICMJE |
Proportion of Participants Failing Treatment for Active Non-Infectious Uveitis by Week 24 [ Time Frame: Baseline to Week 24 ] Treatment failure will be defined as a participant meeting at least one of the following criteria in at least one eye:
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Efficacy and Safety of Filgotinib in Adults With Active Noninfectious Uveitis | ||||
Official Title ICMJE | A Phase 2, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Filgotinib in Subjects With Active Noninfectious Uveitis | ||||
Brief 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 in participants failing treatment for active noninfectious uveitis. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Noninfectious Uveitis | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
74 | ||||
Original Estimated Enrollment ICMJE |
110 | ||||
Estimated Study Completion Date ICMJE | August 2021 | ||||
Actual Primary Completion Date | December 29, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/ Exclusion criteria may apply. |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Australia, Canada, Germany, Israel, New Zealand, Singapore, United Kingdom, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03207815 | ||||
Other Study ID Numbers ICMJE | GS-US-432-4097 2017-001485-17 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Gilead Sciences | ||||
Study Sponsor ICMJE | Gilead Sciences | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Gilead Sciences | ||||
Verification Date | January 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |