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Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD)

A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD)

NCT03046056•Gilead Sciences

View on ClinicalTrials.gov

Summary

The primary objective of this study is to evaluate the efficacy of filgotinib, when compared to placebo, in establishing clinical remission defined as Crohn's disease activity index (CDAI) \< 150, at Week 24 in participants with small bowel Crohn's disease (CD). Participants will have the option to enter a separate long-term extension study if they meet eligibility requirements.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Males or non-pregnant, nonlactating females, ages 18 to 75 years, inclusive based on the date of screening visit
•Moderately or severely active CD
•Minimum duration of CD of at least 6 months
•Presence of diseased small bowel (SB) segments in at least 1 of the following segments: terminal ileum, distal ileum, or jejunum
•Patients with additional colonic involvement of CD are permitted in study as long as SBCD is present
•Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents (depending on current country treatment recommendations/guidelines):
•* Corticosteroids
•* Immunomodulators
•* Tumor necrosis factor-alpha (TNFα) antagonists
•* Vedolizumab
+2 more criteria

Exclusion Criteria

•Presence of symptomatic or clinically significant (eg, obstructive or symptomatic) strictures or stenosis.
•Presence of fistulae
•Evidence of short bowel syndrome
•Presence of ulcerative colitis, indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon
•History of total colectomy, subtotal-colectomy, presence of ileostomy or colostomy, or likely requirement for surgery during the study
•Use of any prohibited concomitant medications as described in the study protocol
•Active tuberculosis (TB) or history of latent TB that has not been treated

Locations (38)

University of Miami Crohn's and Colitis Center

Miami, Florida, United States

Center for lnterventional Endoscopy- Florida Hospital

Orlando, Florida, United States

University of South Florida South Tampa campus

Tampa, Florida, United States

Indiana University Health University Hospital

Indianapolis, Indiana, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Gastro Center of Maryland

Columbia, Maryland, United States

Meritus Center for Clinical Research

Hagerstown, Maryland, United States

Clinical Research Institute of Michigan

Chesterfield, Michigan, United States

Fargo Gastroenterology and Hepatology Clinic

Fargo, North Dakota, United States

Gastro One

Germantown, Tennessee, United States

Key Dates

Start Date

April 11, 2017

Primary Completion Date

July 20, 2020

Completion Date

July 20, 2020

Last Updated

August 23, 2021

Enrollment

ACTUAL participants

Conditions

Small Bowel Crohn's Disease

Interventions

Filgotinib

DRUG

Placebo to match filgotinib

DRUG

Response Assessment in SB CD

NCT03646708

Small Bowel Crohn's Disease

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 23, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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