A Dose Ranging Study of AIN457 in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

Phase 2

Completed

Brief 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).

Recruitment & Eligibility

Inclusion Criteria

Chronic plaque-type psoriasis diagnosed for at least 6 months at time of randomization

At 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.

Exclusion Criteria

Forms of psoriasis other than chronic plaque-type
Drug-induced psoriasis (e.g., new onset or current exacerbation from beta-blockers, calcium channel inhibitors or lithium) at randomization
Previous exposure to AIN457
Ongoing use of prohibited psoriasis treatments / medications and other prohibited medication at randomization. Washout periods detailed in the protocol have to be adhered to
Known immunosuppression (e.g., AIDS) at screening and / or randomization
History or evidence of active tuberculosis at screening
Active systemic infections (other than common cold)
History or symptoms of malignancy of any organ system, treated or untreated, within the past 5 years.
Any severe, progressive or uncontrolled medical condition at randomization that in the judgment of the investigator prevents the patient from participating in the study
Any clinically significant abnormal laboratory tests at randomization, that in the judgment of the investigator prevents the patient from participating in the study
Inability or unwillingness to undergo repeated venipuntures
History or evidence of drug or alcohol abuse
Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply

Arm && Interventions

Primary Outcome Measures

Name	Time	Method
Percentage of Participants of Reponders of Psoriasis Area and Severity Index (PASI) 75 Achievement at Week 13	week 13	PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).

Secondary Outcome Measures

Name	Time	Method
To Assess the Time to Relapse	37 weeks	Relapse is defined as the loss of at least 50% of the maximum PASI change from baseline achieved at any time before that visit and analyzed only for the active treatment groups.
Percentage of Participants With Investigator's Global Assessment (IGA) Response	Week 2, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37	IGA treatment response is defined as achievement of IGA 0 (clear) or 1 (almost clear) and improvement of at least 2 points on the IGA scale compare with baseline.
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 50, PASI 75 or PASI 90)	Week 2, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37	PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area\* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).