Study to Evaluate Safety and Efficacy of Different Doses of Bimekizumab in Patients With Chronic Plaque Psoriasis
Condition: Chronic Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Bimekizumab; Placebo
Intervention description: Subjects will be randomized to receive a combination of injections of Bimekizumab.; Subjects randomized to the placebo group, will receive a combination of several injections of Placebo to maintain the blinding.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 250.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriasis; Chronic Plaque Psoriasis; Bimekizumab

Summary:

      This is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled,
      parallel-group, dose ranging study to investigate the safety, efficacy, pharmacokinetics
      (PK), and pharmacodynamics (PD) of Bimekizumab compared with placebo in adult subjects with
      moderate to severe chronic plaque psoriasis in order to guide the selection of doses and
      clinical indices in the Phase 3 development program.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has provided informed consent

          -  Chronic plaque psoriasis for at least 6 months prior to Screening

          -  PASI (Psoriasis Area and Severity Index) >=12 and BSA (body surface area) >=10% and
             IGA (Investigator's Global Assessment) score 3 or greater on a 5-point scale

          -  Candidates for systemic psoriasis therapy and/or phototherapy and/or chemophototherapy

          -  Female subjects must be postmenopausal, permanently sterilized or, if of childbearing
             potential, must be willing to use a highly effective method of contraception up till
             20 weeks after last administration of study drug

          -  Male subjects with a partner of childbearing potential must be willing to use a condom
             when sexually active, up till 20 weeks after the last administration of study
             medication

        Exclusion Criteria:

          -  Subjects with erythrodermic, guttate, pustular form of psoriasis, or drug-induced
             psoriasis

          -  Subject has any severe, progressive and/or uncontrolled renal, hepatic, hematological,
             endocrine, pulmonary, cardiac, gastrointestinal or neurological disease

          -  Subject has any significant concurrent medical condition or laboratory abnormalities,
             as defined in the study protocol

          -  Subject taking prohibited psoriatic medications

          -  Subject receiving any live vaccines within 8 weeks prior to the Baseline and subjects
             receiving Bacillus Calmette-Guerin (BCG) vaccination within 1 year prior to study drug
             administration

          -  Subject has previously received treatment with any anti-interleukin-17 (anti-IL-17)
             therapy or has been exposed to more than 1 biological response modifier (limited to
             anti-tumor necrosis factor (TNF) or IL-12/23) for psoriatic arthritis or psoriasis
             prior to the Baseline

          -  Subject has any current sign or symptom that may indicate an active infection (except
             for common cold)