A study evaluating the effect of Filgotinib dose de-escalation in patients with ulcerative colitis in remissio
- Conditions
- Health Condition 1: K515- Left sided colitisHealth Condition 2: K518- Other ulcerative colitisHealth Condition 3: K513- Ulcerative (chronic) rectosigmoiditisHealth Condition 4: K51- Ulcerative colitisHealth Condition 5: K519- Ulcerative colitis, unspecified
- Registration Number
- CTRI/2023/05/052646
- Lead Sponsor
- Galapagos NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1) Subjects must be participating in the SELECTION-LTE study, currently on 200 mg Filgotinib q.d. and fulfill the following conditions:
a) pMCS remission1 over a period of at least 2 consecutive quarterly visits in the SELECTION-LTE study prior to and including screening of the present study
b) free of corticosteroids for at least 12 weeks prior to and including baseline
c) FCP less than or equals to 250 microgram per gram at last observation
d) sigmoidoscopy ES of 0 or 1 (local score) at screening.
2) Female subjects 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.
3) Male subjects and female subjects of childbearing potential must agree to use highly effective contraception measures as defined in the protocol.
4) Willing to refrain from live attenuated vaccines during the study and for 12 weeks after the last dose of Filgotinib in the study.
1) 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.
2) Subject has a known hypersensitivity to Filgotinib ingredients or history of a significant allergic reaction to Filgotinib ingredients as determined by the investigator.
3) Female subject who is pregnant or breastfeeding, or intending to become pregnant or breastfeed, and or 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.
4) Male subject unwilling to refrain from sperm donation for at least 90 days after the last dose of investigational product.
5) Subject is unable or unwilling to comply with restrictions regarding prior and concomitant medication as described in the protocol.
6) Subject has a positive QuantiFERON® tuberculosis test at screening or subject has 2 indeterminate QuantiFERON® TB test results who require IP treatment interruption.
7) History of malignancy except for subjects who have been successfully treated for nonmelanoma skin cancer or cervical carcinoma in situ.
8) Subject meets discontinuation criteria of the SELECTION-LTE study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants in Corticosteroid-free Clinical Remission Based on Modified Mayo Clinical Score (mMCS) at Week 48Timepoint: Percentage of Participants in Corticosteroid-free Clinical Remission Based on Modified Mayo Clinical Score (mMCS) at Week 48
- Secondary Outcome Measures
Name Time Method 6.Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events, and TEAEs Leading to Treatment DiscontinuationTimepoint: Baseline up to 216 weeks;Change From Baseline in C-Reactive Protein (CRP) up to Week 48Timepoint: Baseline, up to Week 48;Change From Baseline in Fecal Calprotectin (FCP) up to Week 48Timepoint: Baseline, up to Week 48;Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 48Timepoint: Baseline, Week 48;Time to ES-Confirmed UC FlareTimepoint: Baseline (Day 1) up to 216 weeks;Time to Patient-Reported Outcome Based on 2 Items (PRO2) FlareTimepoint: Baseline (Day 1) up to 216 weeks