Multiple-loading Dose Regimen Study in Patients With Chronic Plaque-type Psoriasis

Study Overview
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Brief Summary
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Loading dose, four arm, double-blind, parallel group, placebo-controlled study comparing single and multiple doses of AIN457 to placebo in patients with a diagnosis of moderate to severe chronic plaque psoriasis.

Official Title
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Phase II Randomized, Double-blind, Multi-center, Parallel-group, Placebo-controlled Multiple-loading Dose Regimen Study to Assess the Safety, Efficacy and Duration of Response of AIN457 in Patients With Chronic Plaque-type Psoriasis.

Conditions
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Chronic Plaque Psoriasis

Intervention / Treatment
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* Drug: AIN457
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of plaque psoriasis for at least 6 months prior to screening. The patients must meet all of the following criterion: Coverage of the body surface area (BSA) of 10% or more with plaques A score of 3 or more on the IGA scale A PASI score of at least 12 at baseline Exclusion Criteria: Have forms of psoriasis other than the required plaque psoriasis Women of childbearing potential Recent use of investigational drugs or treatment with other biological therapies (wash-out periods required) Previous treatment with this investigational drug Subjects with active or history of clinically significant cardiac, kidney or liver abnormalities; Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AIN457 3 mg/kg<br>Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29. | Drug: AIN457<br>* AIN457 was administered intravenously.<br>* Other names: Secukinumab;Drug: Placebo<br>* Matching placebo to AIN457 was administered intravenously.<br>|
| Experimental: AIN457 10 mg/kg<br>Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29. | Drug: AIN457<br>* AIN457 was administered intravenously.<br>* Other names: Secukinumab;Drug: Placebo<br>* Matching placebo to AIN457 was administered intravenously.<br>|
| Experimental: AIN457 10 mg/kg x3<br>Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29. | Drug: AIN457<br>* AIN457 was administered intravenously.<br>* Other names: Secukinumab;|
| Placebo Comparator: Placebo<br>Participants randomized to this arm received matching placebo to AIN457 on days 1, 15 and 29 | Drug: Placebo<br>* Matching placebo to AIN457 was administered intravenously.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores | 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). | Baseline, Week 12 | 
| Percentage of Participants Who Had Not Relapsed at Any Time in the Trial | This outcome measure shows the proportion of participants in each of the AIN457 treatment groups who were relapse free throughout the study up to and including week 56. | Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With at Least 50% Improvement From Baseline in PASI | 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). | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, end of study (EOS) (up to week 56) | 
| Percentage of Participants With at Least 75% or 90% Improvement From Baseline in PASI | 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). | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, EOS (up to week 56) | 
| Percentage of Participants in Each Investigator Global Assessment (IGA) Category | The IGA scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 = very severe. | Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, EOS (up to week 56) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Plaque, psoriasis, inflammatory skin disease, skin condition, thickening, flaking, scaly patches, skin disease