A Double-blind, Randomized, Placebo-controlled Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Multiple Doses of UCB4940 Administered as Add-on to Certolizumab Pegol Therapy in Subjects With Moderate-to-Severe Rheumatoid Arthritis
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- UCB Celltech
- Enrollment
- 159
- Locations
- 21
- Primary Endpoint
- Change from Baseline 2 in DAS28(CRP)
Study Overview
Brief Summary
The purpose of this study is to evaluate the safety, efficacy and body distribution of Bimekizumab (UCB4940) when added to Certolizumab Pegol treatment in patients with Rheumatoid Arthritis. Neither the patient nor the doctor will know the treatment group.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •To be eligible to participate in this study, all of the following criteria must be met:
- •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.
Exclusion Criteria
- •Subjects are not permitted to enroll in the study if any of the following criteria is met:
- •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
- •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.
Arms & Interventions
CZP / CZP + PBO / CZP
Certolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every two weeks) until Week 30
+Placebo from Week 8 to Week 18
Intervention: Placebo (Other)
CZP / CZP/ CZP
Certolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every two Weeks) until Week 30
Intervention: Certolizumab Pegol (Biological)
CZP / CZP + UCB4940 / CZP
Certolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every two weeks) until Week 30
+ UCB4940 from Week 8 until Week 18
Intervention: Certolizumab Pegol (Biological)
CZP / CZP + UCB4940 / CZP
Certolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every two weeks) until Week 30
+ UCB4940 from Week 8 until Week 18
Intervention: Bimekizumab (Biological)
CZP / CZP + PBO / CZP
Certolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every two weeks) until Week 30
+Placebo from Week 8 to Week 18
Intervention: Certolizumab Pegol (Biological)
Outcomes
Primary Outcomes
Change from Baseline 2 in DAS28(CRP)
Time Frame: Week 20
DAS28 (Disease Activity Score 28) is a measure of disease activity in Rheumatoid Arthritis (RA) and is a composite score derived from the number of swollen and tender joints (out of 28), the CRP value and the patient global assessment of disease activity.
Incidence of Adverse Events
Time Frame: Screening (D-28) until final study visit (Week 44)
All adverse events (AEs) are recorded during the entire study period.
Secondary Outcomes
- ACR50 response based on Baseline 2(Week 20)
- Percent improvement in ACR (American College of Rheumatology) criteria (ACRn) based on Baseline 2(Week 20)
- ACR20 response based on Baseline 2(Week 20)
- ACR70 response based on Baseline 2(Week 20)
- DAS28(CRP) remission(Week 20)