Vanderbilt Clinical Trials

Filgotinib in Long-Term Extension Study of Adults With Ulcerative Colitis

Purpose

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 ulcerative colitis (UC).

Condition

Ulcerative Colitis

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Must have the ability to understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of study procedures associated with this trial - Must have enrolled in Gilead-sponsored UC parent protocol GS US 418-3898 or any other Gilead/Galapagos-sponsored filgotinib treatment study for UC - Must have completed all required procedures or met protocol-specified efficacy discontinuation criteria in a prior filgotinib treatment study for UC - Females of childbearing potential must have a negative pregnancy test at Day 1 - Female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception for the duration described - Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose of study drug

Exclusion Criteria

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 - Females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods as defined - Use of prohibited medications as outlined in the protocol NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Double (Participant, Investigator)
Masking Description: Only 3 arms are blinded in this study.

Arm Groups

Arm	Description	Assigned Intervention
Experimental Filgotinib 200 mg (blinded dosing)	Filgotinib 200 mg + placebo to match filgotinib 100 mg for up to 336 weeks	Drug: Filgotinib Tablet(s) administered orally once daily Other names: GS-6034 GLPG0634 Drug: Placebo Tablet(s) administered orally once daily
Experimental Filgotinib 100 mg (blinded dosing)	Filgotinib 100 mg + placebo to match filgotinib 200 mg for up to 336 weeks	Drug: Filgotinib Tablet(s) administered orally once daily Other names: GS-6034 GLPG0634 Drug: Placebo Tablet(s) administered orally once daily
Placebo Comparator Placebo (blinded dosing)	Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg for up to 336 weeks	Drug: Placebo Tablet(s) administered orally once daily
Experimental Filgotinib 200 mg (open-label)	Filgotinib 200 mg for up to 336 weeks	Drug: Filgotinib Tablet(s) administered orally once daily Other names: GS-6034 GLPG0634
Experimental Filgotinib 100 mg (open-label)	Filgotinib 100 mg for up to 336 weeks	Drug: Filgotinib Tablet(s) administered orally once daily Other names: GS-6034 GLPG0634

More Details

Status: Active, not recruiting
Sponsor: Galapagos NV

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.