Rheumatoid arthritis MedDRA version: 18.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
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: UCB4940
Concentration unit: m
Sponsors
UCB Celltech, UK Registered Branch of UCB Pharma SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subject is informed and given approved written Informed Consent Form (ICF). • Subject is considered reliable and capable of adhering to the protocol. • Subject must have a diagnosis of adult-onset moderate-to-severe RA of at least 6 months’ duration as defined by ACR/EULAR 2010 classification criteria. • Subject must have: - =6 tender joints (out of 68) - =6 swollen joints (out of 66) - CRP=10.0mg/L . • Subject must have had inadequate response to at least 1 synthetic DMARD. • Subject is at least 18 years and less than 70 years of age at Visit 1 (Screening). • Female subjects must either be: - postmenopausal - permanently sterilized or, - if of childbearing potential, must be willing to use at least 2 effective methods of contraception, • Male subjects with partners of childbearing potential must be willing to use a condom when sexually active, during the study and for 5 months after last administration of study drug. 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 170 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 previously participated in this study or has previously been assigned to treatment in a study of the investigational medicinal product (IMP) under investigation in this study (UCB4940 and/or CZP). • Subject has a history or active systemic/respiratory infection due to fungal, parasitic, or mycotic pathogens. • Subjects with known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent TB infection are excluded. • Subject is at high risk of infection. • Subject has an active infection or has had a serious infection within 12 weeks prior to the first dose of study drug at Week 0. • Subject has renal or liver impairment. • Subject has a current or past history of gastrointestinal ulceration. • Subject has active neoplastic disease or history of neoplastic disease. • Subject has a concomitant diagnosis of any other inflammatory condition. • Subject has a secondary, non-inflammatory condition or a known diagnosis of fibromyalgia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. Evaluate the safety and tolerability of UCB4940 as an add-on therapy to CZP and background conventional DMARDs compared to placebo plus CZP treatment and background conventional DMARDs 2. Evaluate the efficacy of UCB4940 as an add-on therapy to CZP and background conventional DMARDs compared to placebo plus CZP treatment and background conventional DMARDs at Week 20 ;Secondary Objective: Evaluate treatment with UCB4940 as add-on therapy to CZP and background conventional DMARDs compared to placebo plus CZP treatment and background conventional DMARDs with regard to disease activity of RA at different time points Evaluate the PK of multiple doses of UCB4940 in the presence of CZP Evaluate the PK of multiple doses of CZP in the presence of UCB4940 ;Primary end point(s): • Incidence of adverse events • Change from Baseline 2 in DAS28(CRP) ;Timepoint(s) of evaluation of this end point: • Incidence of adverse events from screening (D-28) till final study visit (week 44) • Change from Baseline 2 in DAS28(CRP) - week 20 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Percent improvement in ACR criteria (ACRn) based on Baseline 2 • ACR20 response based on Baseline 2 • ACR50 response based on Baseline 2 • ACR70 response based on Baseline 2 • DAS28(CRP) remission;Timepoint(s) of evaluation of this end point: week 20 | — |
Countries
Czech Republic, Georgia, Hungary, Moldova, Republic of, Russian Federation, Slovakia, United Kingdom
Contacts
Public ContactClinical Trial Information Desk
UCB BIOSCIENCES GmbH
Outcome results
None listed