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.

• Register: EUCTR
• Last refreshed on: 26 November 2018
• Main ID: EUCTR2016-000420-26-CZ
• Date of registration: 27/07/2016
• Prospective Registration: Yes
• Primary sponsor: UCB Biopharma SPRL
• Public title: 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.
• Scientific title: A MULTICENTER, SUBJECT-BLIND, INVESTIGATOR-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY, SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF AN IV LOADING DOSE FOLLOWED BY SC ADMINISTRATION OF BIMEKIZUMAB (UCB4940) IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS
• Date of first enrolment: 06/10/2016
• Target sample size: 60
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-000420-26
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Bulgaria, Czech Republic, France, Georgia, Italy, Moldova, Republic of, Poland, Romania, South Africa, Spain, United Kingdom

Contacts

• Name: Clin Trial Reg & Results Disclosure
• Affiliation: UCB Biosciences GmbH

• Name: Clin Trial Reg & Results Disclosure
• Affiliation: UCB Biosciences GmbH

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

SEVERE ACTIVE ULCERATIVE COLITIS
MedDRA version: 20.0 Level: SOC Classification code 10017947 Term: Gastrointestinal disorders System Organ Class: 10017947 - Gastrointestinal disorders

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Intervention(s)

Product Name: Bimekizumab
Product Code: UCB4940
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: Bimekizumab
CAS Number: 1418205-77-2
Current Sponsor code: CDP4940
Other descriptive name: UCB4940
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 160-
Pharmaceutical form of the placebo: Solution for injection/infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Primary end point(s): Proportion of Participants with Clinical Response (Per Mayo Score) at week 8

Secondary Objective: To assess the safety and PK of bimekizumab in adults with active ulcerative colitis who have not responded to standard therapy.

Main Objective: To assess the efficacy of bimekizumab in adults with active ulcerative colitis who have not responded to standard therapy.

Timepoint(s) of evaluation of this end point: at week 8

Secondary Outcome(s)

Secondary end point(s): -Proportion of Participants in Clinical Remission at Week 8
-Proportion of Participants with Mucosal Healing at Week 8
-Proportion of Participants With Stool Frequency Subscore Indicative of Mild Disease (a Score of 0 or 1) at Week 8
-Proportion of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (a Score of 0 or 1) at Week 8
-Proportion of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (a Score of 0 or 1) at Week 8
-Change from Baseline in CRP plasma levels at Week 8
-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 20

Secondary ID(s)

UC0011

Source(s) of Monetary Support

UCB Biopharma Sprl