A study to test the effectiveness of bimekizumab as a treatment for ulcerative colitis to look for unwanted side effects and to measure how the drug is distributed, modified and cleared from the body.

Phase 1

• Conditions: SEVERE ACTIVE ULCERATIVE COLITIS; MedDRA version: 20.0Level: SOCClassification code 10017947Term: Gastrointestinal disordersSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2016-000420-26-CZ
• Lead Sponsor: CB Biopharma SPR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-27
• Last Update Posted: 26 November 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

-Subject has a diagnosis of Ulcerative Colitis (UC) confirmed (at least 90 days prior to Visit 1a) by clinical, endoscopic, and histologic evidence
- Subject has a Mayo endoscopy subscore >=2
- Subject has a Mayo rectal bleeding subscore >=1
- Subject has moderate to severe active UC - Total Mayo score 6 to 12 within 10 (±4) days prior to Visit 2 (Week 0)
- Subject has responded inadequately to convention therapy for UC
- Subjets may have received treamtment with 1 biological therapy or a calcineurin inhibitor
- Woman with childbearing potential must be either postmenopausal, permanently sterilized or willing
to use at least 1 highly effective method of contraception in addition to a barrier method
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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- Subject who has had a resective colonic surgery, or has an ostomy or ileoanal pouch or is planning any resection while enrolled in the study
- Subject with current diagnosis of Crohn´s Disease (CD) or indeterminant colitis or acute diverticulitis based on medical history
- Subject has an extension of disease limited to ulcerative proctitis (disease extension) <15cm from the anal verge
- Subject requiring immediate surgical, endoscopic or radiological intervention due to toxic megacolo intraabdominal or perianal abscess

Study & Design

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