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

UCB

Status and phase: Completed; Phase 3

Conditions: Psoriatic Arthritis

Treatments: Drug: Bimekizumab; Drug: Adalimumab; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03895203

PA0010

2017-002322-20 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 852 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 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. Subjects with a diagnosis of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease (IBD) are allowed as long as they have no active symptomatic disease at Screening or Baseline
• Subject had acute anterior uveitis within 6 weeks of Baseline
• Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer
• Subject has a form of PSO other than chronic plaque-type (eg, pustular, erythrodermic and guttate PSO, or drug-induced PSO)
• Presence of active suicidal ideation, or moderately severe major depression or severe major depression
• Subject has a history of chronic alcohol or drug abuse within 6 months prior to Screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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852 participants in 3 patient groups, including a placebo group

Bimekzumab dosage regimen

Experimental group

Description:

Subjects randomized to this arm will receive assigned bimekizumab dosage regimen and placebo to maintain the blinding with adalimumab and placebo arms during the Treatment Period.

Treatment:

Other: Placebo

Drug: Bimekizumab

Adalimumab dosage regimen

Active Comparator group

Description:

Subjects randomized to this arm will receive the assigned adalimumab dosage regimen during the Treatment Period.

Treatment:

Drug: Adalimumab

Placebo

Placebo Comparator group

Description:

Subjects randomized to this arm will receive placebo during the Double-Blind Treatment Period and will be reallocated to receive bimekizumab dosage regimen during the Maintenance Period.

Treatment:

Other: Placebo

Drug: Bimekizumab