A Study to Test the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis

Phase 3

Completed

• Conditions: Psoriatic arthritis

• Registration Number: JPRN-jRCT2080224795
• Lead Sponsor: CB Japan Co., Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-23
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written
Informed Consent form is signed and dated by the subject and/or legal representative. If a
subject is <20 years of age, written informed consent will be obtained from both the subject
and the legal representative.
-Subject is male or female at least 18 years of age
-Female subject must be postmenopausal, permanently sterilized or willing to use a highly effective method of contraception
-Documented diagnosis of adult-onset Psoriatic Arthritis (PsA) meeting the Classification Criteria for Psoriatic Arthritis (CASPAR) for at least 6 months prior to Screening with active PsA and must have at Baseline tender joint count (TJC) >=3 out of 68 and swollen joint count (SJC) >=3 out of 66
-Subject must be negative for rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies
-Subject must have at least 1 active psoriatic lesion(s) and/or a documented history of psoriasis (PSO)
-Subject must be a suitable candidate for treatment with adalimumab and has no contraindications to receive adalimumab as per the local label as assessed by the Investigator
-Subjects currently taking NSAIDs, cyclooxygenase 2 (COX-2) inhibitors, analgesics (including mild opioids), corticosteroids, methotrexate (MTX), leflunomide (LEF), sulfasalazine (SSZ), hydroxychloroquine (HCQ) AND/OR apremilast can be allowed if they fulfill specific requirements prior to study entry

Exclusion Criteria

-Female subjects who are breastfeeding(including pumping), pregnant, or plan to become pregnant during the study
-Subjects with current or prior exposure to any biologics for the treatment of Psoriatic Arthritis (PsA) or Psoriasis (PSO)
-Subject has an active infection or a history of recent serious infections
-Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection
-Subject has a diagnosis of inflammatory conditions other than PSO or PsA including, but not limited to RA, sarcoidosis, systemic lupus erythematosus, reactive arthritis, Crohn's disease, or ulcerative colitis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified