Study of Secukinumab With 2 mL Pre-filled Syringes
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Placebo; Secukinumab 2 mL form; Secukinumab 1 mL form
Intervention description: 2 mL + 2 x 1 mL Placebo s.c. at randomization, weeks 1, 3, and 4, thereafter 4-weekly until week 48; Secukinumab 300 mg/2mL + 2 x 1 mL placebo s.c. at randomization, week 1 , 3, 4, thereafter 4-weekly until Week 48; Secukinumab 150 mg/1mL x 2 + 2 mL placebo s.c. at randomization, week 1 , 3, 4, thereafter 4-weekly until 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: 214.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: psoriasis; secukinumab; pre-filled syringes

Summary:

      The aim of the study was to demonstrate efficacy, safety and tolerability of 2 mL pre-filled
      syringe of 300 mg secukinumab in treatment of moderate to severe plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects eligible for inclusion in this study must fulfill all of the following criteria:

          1. Subjects must be able to understand and communicate with the investigator and comply
             with the requirements of the study and must give a written, signed and dated informed
             consent before any study related activity is performed. Where relevant, a legal
             representative will also sign the informed study consent according to local laws and
             regulations.

          2. Men or women of at least 18 years of age at the time of Screening.

          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 have 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 will be considered
             not eligible for this study since UV light exposure is prohibited.

             Note: administration of live vaccines 6 weeks prior to Randomization or during the
             study period is 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 has
             returned to baseline, whichever is longer; or longer if required by local regulations.

          5. 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.

          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 is evidence of local recurrence or metastases (except for
             Bowen's disease, or basal cell carcinoma or actinic keratoses that have 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