A study evaluating the effect of filgotinib dose de-escalation in patients with ulcerative colitis in remissio
- Conditions
- lcerative colitis (UC)MedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2022-000719-30-IT
- Lead Sponsor
- GALAPAGOS NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
- Subjects must be participating in the SELECTION-LTE study, currently on 200 mg filgotinib q.d. and fulfill the following conditions:
• pMCS remission over a period of at least 2 consecutive quarterly visits in the SELECTION-LTE study 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 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.
- Male subjects and female subjects 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.
This list only contains the key inclusion criteria.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
- 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.
- Subject has a known hypersensitivity to filgotinib ingredients or history of a significant allergic reaction to filgotinib ingredients as determined by the investigator.
- Female subject 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 subject unwilling to refrain from sperm donation for at least 90 days after the last dose of investigational product.
- Subject is unable or unwilling to comply with restrictions regarding prior and concomitant medication as described in the protocol.
- Subject has a positive QuantiFERON® tuberculosis (TB) test at screening or subject has 2 indeterminate QuantiFERON® TB test results who require IP treatment interruption.
- History of malignancy except for subjects who have been successfully treated for nonmelanoma skin cancer or cervical carcinoma in situ.
- Subject meets discontinuation criteria of the SELECTION-LTE study.
This list only contains the key exclusion criteria.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of filgotinib in subjects in stable clinical remission on 200 mg filgotinib once daily (q.d.) for whom the dose was decreased to 100 mg q.d. compared to subjects remaining on 200 mg q.d.;Secondary Objective: - To evaluate the effect of dose de-escalation of filgotinib on time to flare. <br>- To evaluate the effect of dose de-escalation of filgotinib on disease-specific biomarkers and Inflammatory Bowel Disease Questionnaire. <br>- To evaluate the safety and tolerability of filgotinib.;Primary end point(s): Proportion of subjects in corticosteroid-free clinical remission based on modified Mayo Clinical Score.;Timepoint(s) of evaluation of this end point: Week 48
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Time to patient-reported outcome based on 2 items (PRO2) flare.<br>- Time to endoscopic score-confirmed ulcerative colitis flare.<br>- Change from baseline in C-reactive protein and fecal calprotectin.<br>- Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) .<br>- Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious Adverse Events (AEs), and TEAEs leading to treatment discontinuation.;Timepoint(s) of evaluation of this end point: Various time points throughout the study as per clinical study design.