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NCT02914535 · ClinicalTrials.gov registry record · Phase 3

Filgotinib in Long-Term Extension Study of Adults With Ulcerative Colitis

A Phase 3 study of Ulcerative Colitis, sponsored by Alfasigma S.p.A..

Active
Registry status
Phase 3
Development phase
1,173
Enrollment target
20
Study locations

NCT02914535 is a Phase 3 study of Ulcerative Colitis that is active but no longer recruiting, run by Alfasigma S.p.A.. The registered enrollment target is 1,173 participants, below the 2,048-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (43% lower). The trial reports 20 study locations across 10 states.

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The verdict

NCT02914535, a Phase 3 study of Ulcerative Colitis, is active but no longer recruiting, sponsored by Alfasigma S.p.A..

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
1,173 participants
Enrollment target
20
Study locations

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

FieldValue
Enrollment Target 1,173 participants
Start Date 2017-02-23
Est. Completion 2026-09
Phase Phase 3

Sponsor

Alfasigma S.p.A.

7 total trials

What the Registry Record Tells You About NCT02914535

The ClinicalTrials.gov registry entry for NCT02914535 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 1,173 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,048-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (43% lower). The listed sponsor is Alfasigma S.p.A., which has 7 total studies on file at ClinicalTrials.gov.

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.

NCT02914535 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Florida, Georgia, California.

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.

What interventions are being tested in trial NCT02914535?

The interventions under investigation include: Placebo (DRUG), Filgotinib (DRUG).

Who is sponsoring clinical trial NCT02914535?

This trial is sponsored by Alfasigma S.p.A., which has 7 total clinical trials registered on ClinicalTrials.gov.

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.