Study of Efficacy and Safety of Secukinumab 2 mL Auto-injector (300 mg) in Subjects With Moderate to Severe Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Placebo 2 mL auto-injector; Placebo 1 mL prefilled syringe; Secukinumab 2 mL auto-injector; Secukinumab 1 mL prefilled syringe
Intervention description: All Placebo patients until week 8 (included): 2 mL auto-injector Placebo + 2x 1 mL prefilled syringe Placebo s.c. at randomization, weeks 1, 2, 3, 4 and 8.
PASI 90 responders at week 12: 2 mL auto-injector placebo + 2x 1 mL prefilled syringe Placebo s.c. at weeks 12, 13, 14, 15, 16 and every 4 weeks thereafter until week 48.
PASI 90 non-responders at week 12: 2 mL secukinumab 300 mg auto-injector + 2x 1 mL prefilled syringe Placebo s.c. at weeks 12, 13, 14, 15, 16 and 4-weekly thereafter until week 48; All Placebo patients until week 8 (included): 2 mL auto-injector Placebo + 2x 1 mL prefilled syringe Placebo s.c. at randomization, weeks 1, 2, 3, 4 and 8.
PASI 90 responders at week 12: 2 mL auto-injector Placebo + 2x 1 mL prefilled syringe Placebo s.c. at weeks 12, 13, 14, 15, 16 and every 4 weeks thereafter until week 48.
PASI 90 non-responders at week 12: 2x 1 mL secukinumab 150 mg prefilled syringe + 2 mL auto-injector Placebo s.c. at weeks 12, 13, 14, 15, 16 and 4-weekly thereafter until week 48; 2 mL secukinumab 300 mg auto-injector + 2x 1 mL prefilled syringe Placebo s.c. at randomization, weeks 1, 2, 3, 4, 8, 12, 13, 14, 15 , 16 and 4-weekly thereafter until week 48; 2 x 1 mL secukinumab 150 mg prefilled syringe + 2 mL auto-injector Placebo s.c. at randomization, weeks 1, 2, 3, 4, 8, 12, 13, 14, 15, 16 and 4-weekly thereafter until week 48
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A Phase IIIb 52-week multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in approximately 120 subjects with moderate to severe plaque-type psoriasis
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 122.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Plaque psoriasis, auto-injector, 2 mL injection, secukinumab

Summary:

      The primary purpose of this study is to assess efficacy, safety and tolerability of a 2 mL
      pre-filled auto-injector (AI) of 300 mg secukinumab in patients with moderate to severe
      plaque psoriasis
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects eligible for inclusion in this study must have fulfilled all of the following
        criteria:

          1. Men or Women of at least 18 years of age at time of Screening

          2. Subjects able to understand and communicate with the investigator and comply with the
             requirements of the study and must have given a written, signed and dated informed
             consent before any study related activity was performed. Where relevant, a legal
             representative signed the informed study consent according to local laws and
             regulations.

          3. Chronic plaque-type psoriasis present for at least 6 months and diagnosed before
             Randomization.

          4. Moderate to severe psoriasis as defined at Randomization by:

               -  PASI score of 12 or greater, and

               -  IGA mod 2011 score of 3 or greater (based on a 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 Randomization.

          2. Ongoing use of prohibited treatments. Washout periods detailed in the protocol had to
             be adhered to. Subjects not willing to limit UV light exposure (e.g., sunbathing
             and/or the use of tanning devices) during the course of the study were considered not
             eligible for this study since UV light exposure was prohibited.

             Note: administration of live vaccines 6 weeks prior to Randomization or during the
             study period was also prohibited.

          3. Previous exposure to secukinumab (AIN457) or any other biologic drug directly
             targeting IL-17 or the IL-17 receptor.

          4. 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 had
             returned to baseline, whichever is longer; or longer if required by local regulations.

          5. Pregnant or nursing (lactating) women, where pregnancy was defined as the state of a
             female after conception and until the termination of gestation, confirmed by a
             positive hCG laboratory test.

          6. History of lymphoproliferative disease or any known malignancy or history of
             malignancy of any organ system treated or untreated within the past 5 years,
             regardless of whether there was evidence of local recurrence or metastases (except for
             Bowen's disease, or basal cell carcinoma or actinic keratoses that had been treated
             with no evidence of recurrence in the past 12 weeks; carcinoma in situ of the cervix
             or non-invasive malignant colon polyps that have been removed).

          7. History of hypersensitivity to any of study drug constituent