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Filgotinib in Long-Term Extension Study of Adults With Ulcerative Colitis
NCT02914535 · View on ClinicalTrials.gov ↗
Study Summary
The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study in ulcerative colitis (UC).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Filgotinib
Study Locations (20)
Florida
- UF Clinical Research Center — Gainesville
- Florida Research Institute — Lakewood Rch
- University of Miami Crohn's and Colitis Center — Miami
- Cordova Research Institute — Miami
- Gastroenterology Group of Naples — Naples
- Advanced Medical Research Center — Port Orange
- Tampa General Hospital — Tampa
- Florida Medical Clinic, P.A — Zephyrhills
Georgia
- Gastroenterology Associates Of Central Georgia, LLC — Macon
- Gastrointestinal Specialists of Georgia — Marietta
- Atlanta Gastroenterology Specialist, PC — Suwanee
California
- VA Long Beach Healthcare System — Long Beach
- Cedars Sinai Medical Center — Los Angeles
Alabama
- Digestive Health Specialists Of The Southeast — Dothan
Arizona
- Mayo Clinic Arizona — Scottsdale
Colorado
- South Denver Gastroenterology, PC — Lone Tree
Connecticut
- Connecticut GI PC-Research Division — Farmington
Iowa
- University of Iowa Hospitals and Clinics — Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,173 participants |
| Start Date | 2017-02-23 |
| Est. Completion | 2026-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02914535
The ClinicalTrials.gov registry entry for NCT02914535 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,173 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alfasigma S.p.A., which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Ulcerative Colitis appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02914535 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Florida, Georgia, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02914535 about?
NCT02914535 is a clinical study titled "Filgotinib in Long-Term Extension Study of Adults With Ulcerative Colitis". The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study in ulcerative colitis (UC).
What is the current status of trial NCT02914535?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,173 participants. The study started on 2017-02-23. Estimated completion is 2026-09.
What conditions does trial NCT02914535 study?
This clinical trial studies the following conditions: Ulcerative Colitis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02914535?
The interventions under investigation include: Placebo (DRUG), Filgotinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02914535?
This trial is sponsored by Alfasigma S.p.A., which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02914535 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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