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Filgotinib in Long-Term Extension Study of Adults With Crohn's Disease

NCT02914600 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1188

Last updated 2024-07-10

Study results available
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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 Crohn's disease (CD).

Conditions

Interventions

DRUG

Filgotinib

Tablet administered orally once a day

DRUG

Placebo

Tablet administered orally once a day

Sponsors & Collaborators

Principal Investigators

  • Galapagos Study Director · Galapagos NV

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-17
Primary Completion
2023-08-01
Completion
2023-08-01
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
  • 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

Drugs
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 NCT02914600 on ClinicalTrials.gov