A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Condition: Chronic Plaque Psoriasis; Moderate to Severe Chronic Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Bimekizumab; Secukinumab; Placebo
Intervention description: Subjects will receive bimekizumab at pre-specified time-points.; Subjects will receive secukinumab at pre-specified time-points.; Subjects will receive placebo at pre-specified time-points to maintain the blinding in the double-blind Treatment Period.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 743.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bimekizumab; PSO; Psoriasis

Summary:

      This is a study to compare the efficacy of bimekizumab versus secukinumab in subjects with
      moderate to severe chronic plaque psoriasis (PSO).
    

Eligibility criteria:

        Inclusion Criteria:

        Double-blind Treatment Period

          -  Male or female at least 18 years of age

          -  Subject must have had chronic plaque psoriasis (PSO) for at least 6 months prior to
             the Screening visit

          -  Subject must have Psoriasis Area Severity Index (PASI) >=12 and body surface area
             (BSA) affected by PSO >=10% and Investigator's Global Assessment (IGA) score >=3 on a
             5 point scale

          -  Subject must be a candidate for systemic PSO therapy and/or phototherapy

          -  Subject must be considered, in the opinion of the Investigator, to be a suitable
             candidate for treatment with secukinumab per regional labeling and has no
             contraindications to receive secukinumab as per the local label

          -  Female subject of childbearing potential must be willing to use highly effective
             method of contraception

        Open-label extension (OLE) Period

          -  Completed the double-blind Treatment Period without meeting any withdrawal criteria

          -  All Week 48 visit assessments completed

          -  Compliant with ongoing clinical study requirements

          -  Signed a separate OLE Period Informed Consent Form (ICF)

          -  Female subject of childbearing potential must be willing to use highly effective
             method of contraception

        OLE2 Period (USA and Canada)

          -  Completed the OLE Period without meeting any withdrawal criteria

          -  Compliant with ongoing clinical study requirements

          -  Female subject of childbearing potential must be willing to use highly effective
             method of contraception

          -  Subjects with a diagnosis of Crohn's disease or ulcerative colitis are allowed as long
             as they have no active symptomatic disease (US only)

          -  Signed a separate OLE2 Period ICF

        Exclusion Criteria:

        Double-blind Treatment Period

          -  Subject has an active infection (except common cold), a serious infection, or a
             history of opportunistic, recurrent or chronic infections

          -  Subject has concurrent acute or chronic viral hepatitis B or C or human
             immunodeficiency virus (HIV) infection

          -  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 any other condition, including medical or psychiatric, which, in the
             Investigator's judgment, would make the subject unsuitable for inclusion in the study

          -  Presence of active suicidal ideation or severe depression

          -  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

        OLE2 Period (USA and Canada)

          -  Subject has developed any medical or psychiatric condition, which, in the
             Investigator's judgment, would make the subject unsuitable for inclusion in OLE2
             Period

          -  Subject had a positive or indeterminate interferon-gamma release assay (IGRA) in the
             OLE study to Week 144, unless appropriately evaluated and treated

          -  Presence of active suicidal ideation or severe depression

          -  Subject has developed any active malignancy or history of malignancy prior to the OLE2
             Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell
             carcinoma, or in situ cervical cancer