Multiple Dose Study of UCB4940 as add-on to Certolizumab Pegol in Subjects With Rheumatoid Arthritis

UCB

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Biological: Certolizumab Pegol; Biological: Bimekizumab; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02430909

RA0123

2014-003307-30 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 159 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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159 participants in 3 patient groups, including a placebo group

CZP / CZP + PBO / CZP

Placebo Comparator group

Description:

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

Treatment:

Biological: Certolizumab Pegol

Other: Placebo

CZP / CZP + UCB4940 / CZP

Experimental group

Description:

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

Treatment:

Biological: Certolizumab Pegol

Biological: Bimekizumab

CZP / CZP/ CZP

Other group

Description:

Certolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every two Weeks) until Week 30

Treatment:

Biological: Certolizumab Pegol