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-DE
• 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: 2018-08-20
• Last Update Posted: 8 November 2021

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) 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 145
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 with the following exceptions:
• Cases of disease limited to the rectum extending <15 cm past the anal verge are allowed to be included in study 1368.17.
• Cases of latent TB. Patients with newly emerging latent TB during preceding study are allowed to be included in study 1368.17, provided they receive appropriate treatment according to local guidelines.

Study & Design

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