Extension Study of Secukinumab Prefilled Syringes in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Completing Preceding Psoriasis Phase III Studies With Secukinumab
Condition: Moderate to Severe Plaque-type Psoriasis
MeSH terms: Psoriasis
Intervention: Secukinumab (AIN457); Placebo
Intervention description: Secukinumab is a new type of psoriasis medication called a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17). IL-17 is believed to be partly responsible for inflammation (pain, swelling, redness). Researchers believe that IL-17 causes symptoms of plaque-type psoriasis like plaques and scales. A product that targets IL-17 therefore may help to relieve these symptoms and conditions.; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1147.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriasis, inflammatory skin disease; scaly patches; secukinumab (AIN457); Psoriasis Area and Severity Index (PASI); Investigator Global Assessment (IGA) mod 2011

Summary:

      This was an extension study of secukinumab prefilled syringes in subjects with moderate to
      severe chronic plaque-type psoriasis completing preceding psoriasis phase III studies with
      secukinumab. Subjects on secukinumab at the end of treatment period in phase III studies
      (e.g., ongoing CAIN457A2302 and CAIN457A2303 and potentially other secukinumab phase III
      studies) were eligible to join this extension study. This extension study was planned to
      collect an additional 2 years of long-term efficacy, safety, and tolerability data of
      secukinumab in either continuous or interrupted therapy (randomized withdrawal period) in
      subjects showing at least partial response to secukinumab and completing treatment period on
      secukinumab in previous phase III studies. In this extension study, the prefilled syringe
      (PFS) liquid formulation of secukinumab were used.
    

Eligibility criteria:

        Key Inclusion Criteria:

        Completed the full study treatment period of 52 weeks in preceding phase III studies, and
        have been receiving secukinumab treatment during the maintenance phase of the preceding
        phase III studies, and show at least a partial response (PASI 50 or better) at Week 52 of
        the preceding phase III studies.

        Written informed consent form.

        Key Exclusion Criteria:

        A protocol deviation in either of the preceding phase III studies which according to the
        investigator prevented the meaningful analysis of the extension study for the individual
        subject.

        Ongoing use of prohibited psoriasis or non-psoriasis treatments.

        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 (>10 mIU/mL).

        Women of child-bearing potential, defined as all women physiologically capable of becoming
        pregnant, unwilling to use effective contraception during the study and for 16 weeks after
        stopping treatment.