AIN457 Regimen Finding Study in Patients With Moderate to Severe Psoriasis
Condition: Chronic Plaque-type Psoriasis
MeSH terms: Psoriasis
Intervention: AIN457; AIN457A; AIN457A; Placebo
Intervention description: Induction with monthly injections - "Monthly": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9; Early loading induction - "Early": secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 2, 3, 5; Placebo - "Placebo": Placebo administered at weeks 1, 2, 3, 5, 9
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 404.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Moderate to severe chronic plaque-type psoriasis; AIN457; dermatology

Summary:

      The purpose of the study is to determine whether, in patients with moderate to severe
      plaque-type psoriasis, AIN457 administered subcutaneously reduces the severity of psoriasis
      symptoms and the extent to which the patient's body area is affected by the disease (compared
      to placebo).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women at least 18 years of age at time of consent

          -  Chronic plaque-type psoriasis diagnosed for at least 6 months at time of randomization

          -  At time of randomization, moderate to severe psoriasis as defined by:

               -  PASI score of 12 or greater and

               -  IGA score of 3 or greater and

               -  Body Surface Area (BSA) affected by plaque-type psoriasis of 10 % or greater

          -  At screening and randomization, chronic plaque-type psoriasis considered inadequately
             controlled by:

               -  topical treatment and/or

               -  phototherapy and/or

               -  previous systemic therapy

        Exclusion Criteria:

          -  Patients meeting any of the following criteria will be excluded from entry into the
             study:

          -  Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and
             guttate psoriasis) at screening or randomization

          -  Drug-induced psoriasis (i.e. new onset or current exacerbation from beta-blockers,
             calcium channel inhibitors or lithium) and randomization

          -  Ongoing use of prohibited psoriasis treatments (e.g., topical or systemic
             corticosteroids, UV therapy) at randomization. Washout periods detailed in the study
             protocol have to be adhered to

          -  Ongoing use of other prohibited treatments at randomization. Washout periods detailed
             in the study protocol have to be adhered to. All prior concomitant medications must be
             on a stable dose for at least four weeks before study drug administration

          -  Known immunosuppression (e.g., AIDS) at screening and / or randomization

          -  History or evidence of active tuberculosis at screening. All patients will be tested
             for tuberculosis status using a blood test (QuantiFERON®-TB Gold In-Tube). Patients
             with evidence of latent tuberculosis may enter the trial after sufficient treatment
             has been initiated according to local regulations.

          -  Active systemic infections (other than common cold) during the two weeks before
             randomization (e.g., hepatitis)

          -  At screening, history or symptoms of malignancy of any organ system (other than
             history of basal cell carcinoma and / or up to three squamous cell carcinomas of the
             skin, if successful treatment has been performed, with no signs of recurrence; actinic
             keratoses, if present at screening, should be treated according to standard therapy
             before randomization), treated or untreated, within the past 5 years, regardless of
             whether there is evidence of local recurrence or metastases

          -  History of congestive heart failure (NYHA functional classification ≥III) at screening
             and / or randomization

          -  History of severe hypersensitivity to any human or humanized biological agents
             (antibody or soluble receptor) at screening and / or randomization

          -  Any severe, progressive or uncontrolled medical condition at randomization that in the
             judgment of the investigator prevents the patient from participating in the study

          -  Pregnant or nursing (lactating) women