Long-Term Filgotinib for Ulcerative Colitis
(SELECTIONLTE Trial)

Recruiting in Palo Alto (17 mi)

+322 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Alfasigma S.p.A.

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial aims to observe the safety of filgotinib in adults with ulcerative colitis who were part of an earlier study. Filgotinib reduces inflammation by blocking certain proteins. The goal is to ensure it is safe for extended use.

Research Team

Galapagos Study Director

Principal Investigator

Galapagos NV

Eligibility Criteria

This trial is for adults who've previously been in a filgotinib study for ulcerative colitis. They must agree to use contraception if of childbearing potential, avoid certain vaccines, and have the ability to understand and sign consent forms. Those with known drug hypersensitivity or chronic conditions that could interfere with the study are excluded.

Inclusion Criteria

I am of childbearing age and my pregnancy test was negative.

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

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Exclusion Criteria

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

I am not willing to follow the study's birth control requirements.

Known hypersensitivity to the study drug

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Treatment Details

Interventions

Filgotinib (Janus Kinase (JAK) Inhibitor)

Trial OverviewThe trial is observing long-term safety of filgotinib, an investigational drug for ulcerative colitis. Participants will either continue using filgotinib or receive a placebo based on prior participation in related studies.

Participant Groups

5Treatment groups

Experimental Treatment

Placebo Group

Group I: Filgotinib 200 mg (open-label)Experimental Treatment1 Intervention

Filgotinib 200 mg for up to 336 weeks

Group II: Filgotinib 200 mg (blinded dosing)Experimental Treatment2 Interventions

Filgotinib 200 mg + placebo to match filgotinib 100 mg for up to 336 weeks

Group III: Filgotinib 100 mg (open-label)Experimental Treatment1 Intervention

Filgotinib 100 mg for up to 336 weeks

Group IV: Filgotinib 100 mg (blinded dosing)Experimental Treatment2 Interventions

Filgotinib 100 mg + placebo to match filgotinib 200 mg for up to 336 weeks