This study tests how BI 655130 works in patients with active ulcerative colitis. The study also tests how well BI 655130 is tolerated and whether it helps the patients.

Phase 1

• Conditions: Active ulcerative colitis; MedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2017-000100-20-BE
• Lead Sponsor: SCS Boehringer Ingelheim Comm. V

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-17
• Last Update Posted: 14 April 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

- 18 – 75 years at screening
- Diagnosis of UC =3 months prior to screening.
- Moderately to severely active UC as confirmed by Mayo Score =6
- Receiving conventional, non-biologic therapy for UC.
- Negative colon cancer screening
- Naïve or experienced to TNF antagonists (but have not failed that treatment due to primary non-response or loss of response)
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 9
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

- Patients who have previously failed treatment with any TNF antagonist due to primary non-response or loss of response
- Prior use of any other biological treatment in the past (integrin inhibitors, IL12/23 or IL23 inhibitors, any other investigational biological drugs)
- Extensive colonic resection
- Evidence of infection with C. difficile or other intestinal pathogen < 30 days prior to screening
- Active or latent tuberculosis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified