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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05479058
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Galapagos NV
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Galapagos Study Director
Principal Investigator Affiliation	Galapagos NV
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Belgium, Czechia, France, Germany, Hungary, Italy, Korea, Republic of, Poland, South Africa, Spain, Taiwan, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Ulcerative Colitis

Arms & Interventions

Arms

Experimental: Filgotinib 200 mg

Participants will receive filgotinib 200 mg and placebo to match filgotinib 100 mg. Participants will receive blinded treatment until primary analysis time point (after last participant completes Week 48 post baseline visit or has completed Week 12 post re-escalation visit, or after last follow-up of participant who discontinues prior to Week 48, whichever comes last), with exception of participants with endoscopic score (ES)-confirmed UC flare who will be switched to open-label 200 mg filgotinib q.d. for at least 12 weeks and may continue treatment in case of response until the end of the study. Participants, who are blinded at the time of the primary analysis time point, will receive open-label filgotinib 200 mg q.d. The maximum duration of the treatment will be 216 weeks.

Experimental: Filgotinib 100 mg

Participants will receive filgotinib 100 mg and placebo to match filgotinib 200 mg. Participants will receive blinded treatment until primary analysis time point (after last participant completes Week 48 post baseline visit or has completed Week 12 post re-escalation visit, or after last follow-up of participant who discontinues prior to Week 48, whichever comes last), with exception of participants with ES-confirmed UC flare who will be switched to open-label 200 mg filgotinib q.d. for at least 12 weeks and may continue treatment in case of response until the end of the study. Participants, who are blinded at the time of the primary analysis time point, will receive open-label filgotinib 100 mg q.d. The maximum duration of the treatment will be 216 weeks.

Interventions

Drug: - Filgotinib

Tablets administered orally once daily

Drug: - Placebo

Tablets administered orally once daily

Contact a Trial Team

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University of Miami, Miami, Florida

Status

Recruiting

Address

University of Miami

Miami, Florida, 33136

Site Contact

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