A Study Evaluating the Effect of Filgotinib Dose De-escalation in Participants With Ulcerative Colitis (UC) in Remission

• Status: Recruiting
• Trial end date: 2026-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Participants who are in clinical remission on 200 mg filgotinib once daily (q.d.) for at least 2 consecutive quarterly visits in the ongoing SELECTION-LTE study (GS-US-418-3899, NCT02914535), are planned to be rolled over and randomized in this study. The primary objective of this study is to evaluate the efficacy of filgotinib in participants in stable clinical remission on 200 mg filgotinib q.d. for whom the dose was decreased to 100 mg q.d. compared to participants remaining on 200 mg q.d.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Galapagos NV

Criteria

Key Inclusion Criteria:

• Participants must be participating in the SELECTION-LTE study (GS-US-418-3899), currently on 200 mg filgotinib q.d. and fulfill the following conditions:

• partial Mayo Clinical Score remission over a period of at least 2 consecutive quarterly visits in the SELECTION-LTE study (GS-US-418-3899) prior to and including screening of the present study;

• free of corticosteroids for at least 12 weeks prior to and including baseline;

• FCP ≤250 μg/g at last observation;

• sigmoidoscopy ES of 0 or 1 (local score) at screening.

• Female participants of childbearing potential must have a negative highly sensitive (serum beta human chorionic gonadotropin) pregnancy test during screening and must agree to continued monthly urine dipstick pregnancy testing during filgotinib treatment.

• Male participants and female participants of childbearing potential must agree to use highly effective contraception measures as defined in the protocol.

• Willing to refrain from live attenuated vaccines during the study and for 12 weeks after the last dose of filgotinib in the study.

Key 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 participant unsuitable for the study or would prevent compliance with the study protocol.

• Participant has a known hypersensitivity to filgotinib ingredients or history of a significant allergic reaction to filgotinib ingredients as determined by the investigator.

• Female participant who is pregnant or breastfeeding, or intending to become pregnant or breastfeed, and/or plans to undergo egg donation or egg harvesting for the purpose of current or future fertilization, during the study and until the end of the study.

• Male participant unwilling to refrain from sperm donation for at least 90 days after the last dose of investigational product (IP).

• Participant is unable or unwilling to comply with restrictions regarding prior and concomitant medication as described in the protocol.

• Participant has a positive QuantiFERON® tuberculosis (TB) test at screening or participant has 2 indeterminate QuantiFERON® TB test results who require IP treatment interruption.

• History of malignancy except for participants who have been successfully treated for nonmelanoma skin cancer or cervical carcinoma in situ.

• Participant meets discontinuation criteria of the SELECTION-LTE study (GS-US-418-3899).

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.