ulcerative colitis (UC) MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Trade Name: Jyseleca
Product Name: Filgotinib
Product Code: GLPG0634
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Filgotinib
Current Sponsor code: GLPG0634
Other descriptive name: Jyse
Sponsors
Galapagos NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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 screening of the present study; • free of corticosteroids for at least 12 weeks prior to and including baseline; • FCP =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
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. - 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. - 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 that require IP treatment interruption or subject has signs and symptoms of TB reactivation at screening. - History of malignancy during or in the last 5 years prior to participation in the UC parent studies 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. - To evaluate the effect of dose de-escalation of filgotinib on disease-specific biomarkers and Inflammatory Bowel Disease Questionnaire. - 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Time to patient-reported outcome based on 2 items (PRO2) flare. - Time to endoscopic score-confirmed ulcerative colitis flare. - Change from baseline in C-reactive protein and fecal calprotectin. - Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) . - 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. | — |
Countries
Belgium, Czechia, Czech Republic, France, Germany, Hungary, India, Italy, Korea, Republic of, Poland, South Africa, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactGalapagos Medical Information
Galapagos NV
Outcome results
None listed