A Study to Evaluate the Dose Response Based on the Efficacy, Safety and Tolerability of Bimekizumab in Subjects With Active Psoriatic Arthritis Which is a Type of Inflammatory Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: Placebo; Bimekizumab
Intervention description: Bimekizumab in different dosage regimens.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 206.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriatic Arthritis; PsA; Bimekizumab

Summary:

      This is a study to evaluate the dose response based on the efficacy, safety and tolerability
      of bimekizumab in subjects with active psoriatic arthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has a documented diagnosis of adult-onset PsA classified by Classification
             Criteria for Psoriatic Arthritis (CASPAR) criteria with symptoms for at least 6 months
             prior to Screening, with active psoriatic arthritis (PsA) at Baseline/Day 1, and must
             have at Baseline tender joint count (TJC) >=3 out of 78 and swollen joint count (SJC)
             >=3 out of 76

          -  Subject must be rheumatoid factor and anti-cyclic citrullinated peptide (CCP)
             antibodies negative

          -  Subject must have active psoriatic lesion(s) and/or a documented history of psoriasis

          -  Subjects who are regularly taking nonsteroidal anti-inflammatory drug (NSAIDs)/COX-2
             inhibitors as part of their PsA therapy are required to be on a stable dose/dose
             regimen for at least 14 days before Baseline

          -  Subjects taking corticosteroids must be on an average daily dose of <=10mg/day
             prednisone or equivalent for at least 14 days before Baseline and should remain on a
             stable dose through the Week 16 visit

          -  Subjects taking methotrexate (MTX) (<=25mg /week) are allowed to continue their
             medication if started at least 12 weeks prior to Baseline, with a stable dose for at
             least 8 weeks before randomization

          -  Subjects taking leflunomide (LEF; <=20mg/day or an average of 20mg/day if not dosed
             daily) are allowed to continue their medication if started at least 3 months prior to
             Baseline, with a stable dose for at least 8 weeks before randomization. Dose and
             dosing schedule should remain stable up to Week 16

          -  Subjects may be tumor necrosis factor (TNF) inhibitor naïve or may have received 1
             prior TNF inhibitor. Subjects who have been on a TNF inhibitor previously must have:

               1. experienced an inadequate response to previous treatment given for at least 3
                  months

               2. been intolerant to administration (eg, had a side-effect/adverse event (AE) that
                  led to discontinuation)

               3. lost access to TNF inhibitor for other reasons

        Exclusion Criteria:

          -  Subjects with any current sign or symptom that may indicate an active infection (with
             the exception of the common cold) or has had an infection requiring systemic
             antibiotics within 2 weeks of Baseline/Day 1

          -  Subjects with a history of chronic or recurrent infections, or a serious or
             life-threatening infection within the 6 months prior to the Baseline Visit

          -  Subjects with concurrent acute or chronic viral hepatitis B or C or human
             immunodeficiency virus (HIV) infection

          -  Subjects with known history of or current clinically active infection with
             Histoplasma, Coccidioides, Paracoccidioides, Pneumocystis, Blastomyces, or Aspergillus
             or current active Candidiasis

          -  Subjects receiving any live (includes attenuated) vaccination within the 8 weeks prior
             to Baseline

          -  Subjects with known tuberculosis (TB) infection, at high risk of acquiring TB
             infection, with latent TB infection (LTBI), or current or history of nontuberculous
             mycobacteria (NTMB) infection

          -  Subjects with a diagnosis of inflammatory conditions other than psoriasis or psoriatic
             arthritis

          -  Subjects with concurrent malignancy or a history of malignancy during the past 5 years
             will be excluded, with following exceptions that may be included:

               1. <= 3 excised or ablated basal cell carcinomas of the skin

               2. One squamous cell carcinoma of the skin (stage T1 maximum) successfully excised,
                  or ablated only (other treatments, ie, chemotherapy, do not apply), with no signs
                  of recurrence or metastases for more than 2 years prior to Screening

               3. Actinic keratosis (-es)

               4. Squamous cell carcinoma-in-situ of the skin successfully excised, or ablated,
                  more than 6 months prior to Screening