BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis

Phase 1

• Conditions: Moderate-to-severely active ulcerative colitis; MedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856; Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2018-000334-35-ES
• Lead Sponsor: Boehringer Ingelheim España, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-17
• Last Update Posted: 10 October 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 160

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.
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 160
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

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 clinical trial of medicinal product
• Study Design: Not specified