Plaque Psoriasis Efficacy and Safety With Secukinumab
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Secukinumab
Intervention description: Secukinumab for s.c. injection was supplied in single boxes each containing 2 pre-filled syringes (PFS) of 150 mg secukinumab in a 1 mL liquid formulation. Each 300 mg dose was administered as 2 PFS injections of 150 mg secukinumab.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 16487.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: plaque, psoriasis

Summary:

      To demonstrate in the patient pool of PASI 90 responders at Week 24 that secukinumab 300 mg
      s.c. when administered at a longer dosing interval is non-inferior to secukinumab 300 mg s.c.
      every 4 weeks treatment with respect to maintaining a PASI 90 response rate at Week 52.
    

Eligibility criteria:

        Main Inclusion Criteria:

          1. Chronic plaque-type psoriasis diagnosed for at least 6 months prior to Screening and
             candidate for systemic therapy.

          2. Moderate to severe psoriasis at Baseline as evidenced by:

               -  PASI ≥ 10 and

               -  IGA mod 2011 score of 3 or higher (based on a scale of 0 to 4) and

               -  BSA affected by plaque-type psoriasis of ≥ 10%.

        Main Exclusion Criteria:

          1. History of exposure to any biologic drug taken for the treatment of chronic plaque
             psoriasis or any other indication including but not limited to anti-tumor necrosis
             factor (TNF) alpha, anti interleukin (IL)12/23, or any anti-IL 17A or IL 17A receptor
             (IL 17AR) antibody.

          2. History of hypersensitivity to any of the study drugs or to drugs of similar chemical
             classes.

          3. Forms of psoriasis other than chronic plaque-type (eg, pustular, erythrodermic and
             guttate psoriasis).

          4. Drug-induced psoriasis (ie, new onset or current exacerbation from beta-blockers,
             calcium channel inhibitors or lithium).

          5. Ongoing use of prohibited psoriasis treatments (eg, topical or systemic
             corticosteroids, ultraviolet (UV) therapy).

          6. Ongoing use of other non-psoriasis prohibited treatments. Washout periods detailed in
             the protocol have to be adhered to. All other prior non-psoriasis concomitant
             treatments must be at a stable dose as detailed in the protocol before initiation of
             study drug.

          7. 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 human chorionic gonadotropin (hCG) laboratory test (> 5 mIU/mL).

          8. Women of child-bearing potential, defined as all women physiologically capable of
             becoming pregnant, unless they are using effective methods of contraception during
             dosing of study drug and for 16 weeks after stopping study drug.

          9. Active ongoing inflammatory diseases other than psoriasis that might confound the
             evaluation of the benefit of secukinumab therapy.

         10. Underlying condition (including, but not limited to metabolic, hematologic, renal,
             hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal
             conditions) which, in the opinion of the Investigator, significantly immunocompromises
             the patient and/or places the patient at unacceptable risk for receiving an
             immunomodulatory therapy.