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.

Phase 1

• Conditions: RHEUMATOID ARTHRITIS; MedDRA version: 19.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2016-000393-37-BG
• Lead Sponsor: CB Biopharma Sprl

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-17
• Last Update Posted: 26 September 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified