A study to test the effectiveness of bimekizumab as a treatment for rheumatoid arthritis, 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 MULTIPLE INTRAVENOUS DOSES OF BIMEKIZUMAB (UCB4940) ADMINISTERED TO SUBJECTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000393-37-BG

Enrollment

Registered

2016-06-17

Start date

2016-08-08

Completion date

Unknown

Last updated

2016-09-26

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

Conditions

RHEUMATOID ARTHRITIS MedDRA version: 19.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Product Name: Bimekizumab Product Code: UCB4940 Pharmaceutical Form: Solution for infusion INN or Proposed INN: Bimekizumab CAS Number: 1418205-77-2 Current Sponsor code: CDP4940 Other descriptive na

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Subject must have a diagnosis of adult-onset moderate to severe RA of =15 years duration as defined by ACR/ European League Against Rheumatism 2010 classification criteria -Subject must have had a stable dose MTX for =3 months prior to Visit 1. The stable dose of MTX should be a minimum of 15mg/week; however, a minimum of 10mg/week is acceptable if the subject was previously not able to tolerate 15mg/week -Subject must be biologically naïve -Subject must have the following: - =6 tender joints (out of 68) - =6 swollen joints (out of 66) - CRP=10mg/L -Female subjects must either be: postmenopausal, permanently sterilized or if childbearing potential applicable willing to use 1 highly effective method of contraception 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 has a past medical history or family history of primary immunodeficiency - infected with Tubercolosis (TB) or high risk of acquiring TB infection - female subject who is breastfeeding, pregnant or plans to become pregnant during the study or within 20 weeks following the last IMP dose - Subject has renal or liver impairment, defined as: Serum creatinine level of >=1.4mg/dL (124mol/L) for females and >=1.5mg/dL (133mol/L) for males Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >=2x upper limit of normal (ULN) Total bilirubin >1.5xULN (an isolated total bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin is <35%; (ie, is due to Gilbert's syndrome) - Subject has any other acute or chronic condition which, in the Investigator’s judgment, would make the subject unsuitable for inclusion in the study - Subject has a concomitant diagnosis of any other inflammatory condition - Subject had previous exposure to any biologic treatment (ie, anti-TNF or anti-IL-17 inhibitors)

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the study is to assess the efficacy of bimekizumab versus placebo as add-on therapy to MTX in subjects with moderate to severe RA who are biologically naïve and have an inadequate response to MTX.;Secondary Objective: The secondary objective of the study is to assess the safety, and tolerability of bimekizumab in subjects with moderate to severe RA who are biologically naïve and have an inadequate response to MTX.;Primary end point(s): Percentage of ACR50 (American College of Rheumatology 50% Improvement) Responders at Week 12;Timepoint(s) of evaluation of this end point: at Week 12.	—

Measure

Time frame

Main Objective: The primary objective of the study is to assess the efficacy of bimekizumab versus placebo as add-on therapy to MTX in subjects with moderate to severe RA who are biologically naïve and have an inadequate response to MTX.;Secondary Objective: The secondary objective of the study is to assess the safety, and tolerability of bimekizumab in subjects with moderate to severe RA who are biologically naïve and have an inadequate response to MTX.;Primary end point(s): Percentage of ACR50 (American College of Rheumatology 50% Improvement) Responders at Week 12;Timepoint(s) of evaluation of this end point: at Week 12.

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Secondary

Measure	Time frame
Secondary end point(s): - ACR (American College of Rheumatology) criteria (ACRn[transformed]) at Week 12 - Percentage of ACR20 (American College of Rheumatology 20% Improvement) Responders at Week 12 - Percentage of ACR70 (American College of Rheumatology 70% Improvement) Responders at Week 12 - Percentage of Subjects Achieving Disease Activity Score 28 (DAS28 (CRP)) Remission Status (DAS28 (CRP) < 2.6) at Week 12 -Percentage of Subjects Achieving Disease Activity Score 28 (DAS28 (CRP)) low disease activity (DAS28 (CRP) < 3.2) at Week 12 -Change From Baseline in the Disease Activity Score 28 (DAS28 (CRP)) Response at Week 12;Timepoint(s) of evaluation of this end point: Week 12	—

Measure

Time frame

Secondary end point(s): - ACR (American College of Rheumatology) criteria (ACRn[transformed]) at Week 12 - Percentage of ACR20 (American College of Rheumatology 20% Improvement) Responders at Week 12 - Percentage of ACR70 (American College of Rheumatology 70% Improvement) Responders at Week 12 - Percentage of Subjects Achieving Disease Activity Score 28 (DAS28 (CRP)) Remission Status (DAS28 (CRP) < 2.6) at Week 12 -Percentage of Subjects Achieving Disease Activity Score 28 (DAS28 (CRP)) low disease activity (DAS28 (CRP) < 3.2) at Week 12 -Change From Baseline in the Disease Activity Score 28 (DAS28 (CRP)) Response at Week 12;Timepoint(s) of evaluation of this end point: Week 12

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Countries

Bulgaria, Georgia, Hungary, Macedonia, the former Yugoslav Republic of, Moldova, Republic of, Poland, Romania, Russian Federation, Serbia, 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