A study in patients with mild or moderate ulcerative colitis who take a TNF inhibitor. The study investigates whether bowel inflammation improves when patients take BI 655130 in addition to their current therapy.
- Conditions
- Mild-to-moderately active ulcerative colitis on TNF inhibitor therapyMedDRA version: 19.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2016-004572-21-ES
- Lead Sponsor
- Boehringer Ingelheim España, S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 39
- 18 – 60 years at screening and randomisation
- Diagnosis of ulcerative colitis =4 months prior to screening
- ReceivingTNFi treatment with doses unchanged for =4 months prior to randomisation
- Mild or moderate disease activity, defined as total Mayo Score (MCS) (=10)
- Further criteria apply
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 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- Prior use of more than one different TNF inhibitor or vedolizumab
- Extensive colonic resection
- Evidence of infection with C. difficile or other intestinal pathogen <28 days prior to screening
- Active or latent tuberculosis
- Further criteria apply
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method