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.
- Conditions
- MODERATE TO SEVERE ACTIVE ULCERATIVE COLITISMedDRA version: 20.0Level: SOCClassification code 10017947Term: Gastrointestinal disordersSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2016-000420-26-BG
- Lead Sponsor
- CB Biopharma SPR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
-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 (other than
anti-IL17) or a calcineurin inhibitor
- Female subjects must either be postmenopausal, permanently sterilized or if of childbearing potential must be 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
- 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
- Primary Outcome Measures
Name Time Method Main Objective: To assess the efficacy of bimekizumab in adults with moderate to severe active ulcerative colitis who have not responded to standard therapy.;Secondary Objective: To assess the safety, tolerability and PK of bimekizumab in adults with moderate to severe active ulcerative colitis who have not responded to standard therapy.;Primary end point(s): Proportion of Participants with Clinical Response (Per Mayo Score) at week 8;Timepoint(s) of evaluation of this end point: at week 8
- Secondary Outcome Measures
Name Time Method Secondary end point(s): -Proportion of Participants in Clinical Remission at Week 8<br>-Proportion of Participants with Mucosal Healing at Week 8<br>-Proportion of Participants With Stool Frequency Subscore Indicative of Mild Disease (a Score of 0 or 1) at Week 8<br>-Proportion of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (a Score of 0 or 1) at Week 8<br>-Proportion of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (a Score of 0 or 1) at Week 8<br>-Change from Baseline in CRP plasma levels at Week 8<br>-Incidence of Adverse Events throughout the study conduct up to Week 26;Timepoint(s) of evaluation of this end point: Week 8 up to Week 26