4 Year Extension Study of Efficacy and Safety of Secukinumab in Patients With Moderate to Severe Chronic Plaque-type Psoriasis
Condition: Moderate to Severe Chronic Plaque-Type Psoriasis
MeSH terms: Psoriasis
Intervention: AIN457 150 mg; AIN457 300 mg; Placebo
Intervention description: (1 injection per dose) and placebo to Secukinumab 150 mg; Secukinumab 150 mg (2 injections per dose)
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 675.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriasis; Plaque; Inflammatory skin disease; Scaly patches; AIN457; Secukinumab; Moderate to Severe Plaque-type Psoriasis

Summary:

      CAIN457A2304E1 was an extension study to two phase III studies, CAIN457A2304 and CAIN457A2307
      (core studies). This extension study planned to collect up to four years of long-term safety,
      tolerability and efficacy data of secukinumab in both the fixed interval regimen and the
      retreatment at start of relapse regimen. All subjects who completed the full study treatment
      period (52 weeks) in the cores studies CAIN457A2304 and CAIN457A2307 were eligible to
      participate in this extension study. In this extension study, the prefilled syringe (PFS)
      liquid formulation of secukinumab was used.
    

Eligibility criteria:

        Inclusion 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 consent according to local laws and
             regulations.

          2. Subjects who complete Week 52 of study CAIN457A2304 or complete Week 40 of study
             CAIN457A2307

          3. Subjects expected to benefit from participation in the extension study, as assessed by
             the subject and investigator

        Exclusion Criteria:

          1. A protocol deviation in the core studies which according to the investigator will
             prevent the meaningful analysis of the extension study for the individual subject

          2. Ongoing use of prohibited psoriasis or non-psoriasis treatments. Time period from last
             use of prohibited treatments in the core study to first dose of study drug in this
             extension study.

          3. Subjects expected to be exposed to an undue safety risk if participating in the trial

          4. Current severe progressive or uncontrolled disease which in the judgment of the
             investigator renders the subject unsuitable for the trial

          5. Plans for administration of live vaccines during the study period

          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 (>10 mIU/mL).