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.

Phase 1

• Conditions: Mild-to-moderately active ulcerative colitis on TNF inhibitor therapy; MedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2016-004572-21-DK
• Lead Sponsor: Boehringer Ingelheim Pharma GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-09
• Last Update Posted: 6 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

- 18 – 75 years at screening and randomisation
- Diagnosis of ulcerative colitis = 5 months prior to screening
- ReceivingTNFi treatment with doses unchanged for =4 months (infliximab) or = 2 months (adalimumab and golimumab) 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 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

- Prior use of more than two different TNF inhibitors 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