A Long Term Study to Follow the Safety of a New Treatment in Patients with Crohn’s Disease

Phase 1

• Conditions: Moderately to Severely Active Crohn's Disease (CD); MedDRA version: 20.0Level: LLTClassification code 10013099Term: Disease CrohnsSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2016-002763-34-BE
• Lead Sponsor: Galapagos NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-08
• Last Update Posted: 30 January 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Must have the ability to understand and sign a written ICF, which must be obtained prior to initiation of study procedures associated with this
trial
• Criterion modified per amendment 9
2.1) Must have enrolled in a CD parent protocol, GS-US-419-4015, GSUS-419-4016 or GS-US-419-3895 or any other Gilead/Galapagossponsored filgotinib treatment study for CD
• Females of childbearing potential must have a negative pregnancy test at Day 1 and must agree to continued monthly pregnancy testing during use of filgotinib treatment
• Criterion modified per amendment 9
4.1) Female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified
method(s) of contraception for the duration described in the protocol
• Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose of study drug
• Must have completed all required procedures or met protocol specified efficacy discontinuation criteria in a prior Gilead-sponsored filgotinib
treatment study for CD

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 920
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

• Subjects who are discontinued from a parent study for reasons other than disease worsening, or lack of response or remission; eg, subjects
who discontinue for safety or tolerability issues are not eligible for the present study.
• Known hypersensitivity to the study drug
• Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease, alcohol or drug abuse) that, in the opinion of the
Investigator or Sponsor, would make the subject unsuitable for the study or would prevent compliance with the study protocol
• Criterion modified per amendment 9
4.1) Females who may wish to become pregnant and/or plan to undergo egg donation or egg harvesting for the purpose of current or
future fertilization during the course of the study and for at least 30 days after the last dose of study drug
• Criterion modified per amendment 9
6.1) Females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods as defined
in the protocol
• Use of prohibited concomitant medications as outlined in the protocol

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified