BI 655130 Long-term Treatment in Patients With moderate-to Severe Ulcerative Colitis

Phase 2

Completed

• Conditions: lcerative colitis

• Registration Number: JPRN-jRCT2080224139
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-09
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 535

Inclusion Criteria

Male or female patients, aged equal to or more than 18 years
- Signed and dated written informed consent for 1368.17, in accordance with GCP and local legislation prior to admission into the trial
- Women of childbearing potential (WOCBP) must be ready to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.
- Have completed treatment and the EOT visit in the previous trial and are willing and able to continue treatment in 1368.17.

Exclusion Criteria

- Have experienced study treatment-limiting adverse events during induction treatment with study drug
- Have developed any of the exclusion criteria from the original induction study

Study & Design

• Study Type: Interventional
• Study Design: Not specified