A Study to Test the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active P… (NCT03895203) | Clinical Trial Compass
CompletedPhase 3
A Study to Test the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
United States852 participantsStarted 2019-04-03
Plain-language summary
This is a study to demonstrate the clinical efficacy, safety and tolerability of bimekizumab administered subcutaneously (sc) compared with placebo in the treatment of subjects with active Psoriatic Arthritis (PsA).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the subject
* 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, pregnant, or plan to become pregnant during the study
* Subjects with current or prior exposure to any…
What they're measuring
1
Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 16