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Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohn's Disease

NCT02914561 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1372

Last updated 2023-12-18

Study results available
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Summary

The primary objectives of this study are to evaluate the safety and efficacy of filgotinib during induction and maintenance treatment of moderately to severely active Crohn's disease (CD) in participants who are biologic-naive and biologic-experienced.

Participants who complete the study, or do not meet protocol response or remission criteria at Week 10 will have the option to enter a separate long-term extension (LTE) study (Study GS-US-419-3896).

Conditions

Interventions

DRUG

Filgotinib

Filgotinib tablets administered orally once daily.

OTHER

Placebo

Placebo administered orally once daily.

Sponsors & Collaborators

Principal Investigators

  • Galapagos Study Director · Galapagos NV

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
2016-10-31
Primary Completion
2022-11-11
Completion
2022-11-11
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Bulgaria
  • Canada
  • Croatia
  • Czechia
  • France
  • Georgia
  • Germany
  • Greece
  • Hong Kong
  • Hungary
  • Iceland
  • India
  • Ireland
  • Israel
  • Italy
  • Japan
  • Malaysia
  • Netherlands
  • New Zealand
  • Norway
  • Poland
  • Portugal
  • Romania
  • Russia
  • Serbia
  • Singapore
  • Slovakia
  • South Africa
  • South Korea
  • Spain
  • Sri Lanka
  • Sweden
  • Switzerland
  • Taiwan
  • Ukraine
  • United Kingdom

Study Locations

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Entities

Diseases
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 NCT02914561 on ClinicalTrials.gov