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

NCT03046056 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2021-08-23

Study results available
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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.

Conditions

  • Small Bowel Crohn's Disease

Interventions

DRUG

Filgotinib

Tablet(s) administered orally once daily

DRUG

Placebo to match filgotinib

Tablet(s) administered orally once daily

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-11
Primary Completion
2020-07-20
Completion
2020-07-20
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Canada
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03046056 on ClinicalTrials.gov