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.

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000420-26-CZ

Enrollment

Registered

2016-07-27

Start date

2016-10-06

Completion date

Unknown

Last updated

2018-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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 descr

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the efficacy of bimekizumab in adults with active ulcerative colitis who have not responded to standard therapy.;Secondary Objective: To assess the safety and PK of bimekizumab in adults with 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	—

Measure

Time frame

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

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Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

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

Contacts

Public ContactClin Trial Reg & Results Disclosure

UCB Biosciences GmbH

clinicaltrials@ucb.com49 2173 481515

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026