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.

• Register: EUCTR
• Last refreshed on: 26 September 2016
• Main ID: EUCTR2016-000393-37-BG
• Date of registration: 17/06/2016
• Prospective Registration: Yes
• Primary sponsor: UCB Biopharma Sprl
• Public title: 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.
• Scientific title: 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
• Date of first enrolment: 08/08/2016
• Target sample size: 60
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-000393-37
• 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, Georgia, Hungary, Macedonia, the former Yugoslav Republic of, Moldova, Republic of, Poland, Romania, Russian Federation, Serbia, 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 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:
- 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)


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

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Body processes [G] - Immune system processes [G12]

Intervention(s)

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 name: UCB4940
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 160-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Primary end point(s): Percentage of ACR50 (American College of Rheumatology 50% Improvement) Responders at Week 12

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.

Timepoint(s) of evaluation of this end point: at Week 12.

Secondary Outcome(s)

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

Secondary ID(s)

RA0134

Source(s) of Monetary Support

UCB Biopharma Sprl