Study of Efficacy and Safety of Secukinumab in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Secukinumab 150 mg s.c.; Secukinumab 300 mg s.c.; Placebo
Intervention description: 150 mg s.c. at randomization, Weeks 1, 2, 3, 4 and every 4 weeks till Week 48; 300 mg s.c. at randomization, Weeks 1, 2, 3, 4 and every 4 weeks till Week 48; Placebo 150 or 300 mg s.c at randomization, Weeks 1, 2, 3, 4, and 8. PASI responders at week 12 continued to receive placebo till Week 48. PASI non-responders at Week 12 received Secukinumab 300mg at Weeks 12, 13, 14, 15, 16 and every 4 weeks till Week 48
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 543.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Plaque psoriasis; Secukinumab; Skin condition; skin disease; itching; psoriasis vulgaris; immune-mediated systemic disease; skin lesions; scaly patches; papules; psoriasis

Summary:

      The purpose of this study was to determine if secukinumab is effective and safe in the
      treatment of plaque type psoriasis
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects must give a written, signed and dated informed consent.

          2. Men or women at least 18 years of age at time of screening.

          3. Chronic plaque-type psoriasis present for at least 6 months and diagnosed before
             Baseline.

          4. Moderate to severe psoriasis as defined at Baseline by:

               -  PASI score of 12 or greater, and

               -  IGA mod 2011 score of 3 or greater (based on a static scale of 0 - 4), and

               -  Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater.

          5. Candidate for systemic therapy. This is defined as a subject having moderate to severe
             chronic plaque-type psoriasis that is inadequately controlled by

               -  topical treatment and/or,

               -  phototherapy and/or,

               -  previous systemic therapy.

        Exclusion Criteria:

          1. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and
             guttate psoriasis) at Screening or Baseline.

          2. Drug-induced psoriasis.

          3. Ongoing use of prohibited treatments.

          4. Previous exposure to secukinumab (AIN457) or any other biologic drug directly
             targeting IL-17 or the IL-17 receptor.

          5. Use of other investigational drugs at the time of enrollment, or within 5 half-lives
             of enrollment, or within 30 days until the expected pharmacodynamic effect has
             returned to baseline, whichever is longer; or longer if required by local regulations.

          6. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
             female after conception and until the termination of gestation, confirmed by a
             positive hCG laboratory test.