An open label, long term safety trial of BI 655130 treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials

Phase 2

Withdrawn

• Conditions: bowel inflammation; Ulcerative colitis; 10017969

• Registration Number: NL-OMON48579
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 7

Inclusion Criteria

1. Male or female patients, aged >=18 years;
2. Signed and dated written informed consent for 1368.17, in accordance with GCP and local legislation prior to admission into the trial;
3. Women of childbearing potential (WOCBP) and men able to father a child 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;
Note: A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Tuba ligation is NOT a method of permanent sterilisation. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause;
4. Have completed treatment and the EOT visit in the previous trial and are willing and able to continue treatment in 1368.17.

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Protocol section 2.1.2:<br /><br>The primary endpoint is the number of patients adjusted by the exposure who<br /><br>report a treatment-emergent adverse reaction (TEAE) up to week 336 of the<br /><br>maintenance treatment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Protocol section 2.1.3:<br /><br>The number of patients with clinical remission at week 336 of maintenance<br /><br>treatment.</p><br>