Study of Secukinumab Compared to Ustekinumab in Subjects With Plaque Psoriasis

Study Overview
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Brief Summary
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Demonstrate superiority of secukinumab over ustekinumab in treatment of moderate to severe plaque psoriasis.

Official Title
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A 52-week, Randomized, Double-blind Study of Secukinumab (300 mg) Compared to Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Drug: Secukinumab
* Drug: Ustekinumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must give a written, signed and dated informed consent Chronic plaque-type psoriasis present for at least 6 months before randomization Moderate to severe plaque psoriasis as defined at randomization by: PASI score of ≥12 and Body Surface Area (BSA) affected by plaque-type psoriasis ≥10% and IGA mod 2011 ≥3 (based on a scale of 0-4) Candidate for systemic therapy, defined as having psoriasis inadequately controlled by: Topical treatment (including topical corticosteroids) and/or Phototherapy and/or Previous systemic therapy Exclusion Criteria: Forms of psoriasis other than plaque psoriasis Drug-induced psoriasis Ongoing use of prohibited treatments Previous exposure to secukinumab or any other biologic drug directly targeting IL-17A or IL-17RA, or ustekinumab, or any therapies targeting IL-12 or IL-23 Use of any other investigational drugs within 5 half-lives of the investigational treatment before study drug initiation Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Secukinumab<br>Secukinumab | Drug: Secukinumab<br>* 300mg, s.c. at randomization, Weeks 1, 2 and 3 and thereafter 4-weekly till Week 48<br>|
| Active Comparator: Ustekinumab<br>Ustekinumab | Drug: Ustekinumab<br>* Per approved label, 45 mg or 90 mg s.c. based on subject weight (at randomization visit) to be administered at randomization, Week 4, 16, 28 and 40. At other timepoints subjects will receive placebo injections.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 12 | Number of participants who achieved ≥ 90% reduction in PASI compared to baseline. Logistic regression analysis of PASI 90 response at Week 12 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, upper limbs, trunk, lower limbs; 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 body region(head: 0.1, upper limbs: 0.2, trunk: 0.3, lower limbs: 0.4). | Week 12 | 
| Participants With IGA Mod 2011 0 or 1 at Week 12 | Investigator's Global Assessment uses a scale (IGA mod 2011) that rates disease from a score of 0 (clear skin) to 4 (severe disease) | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 12 | Number of participants who achieved ≥ 75% reduction in PASI at Week 12 compared to baseline. | Week 12 | 
| Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 4 | Number of participants who achieved ≥ 75% reduction in PASI at Week 4 compared to baseline. | Week 4 | 
| Participants Who Achieved Psoriasis Area and Severity Index (PASI) 100 Response at Week 16 | Number of participants who achieved 100% reduction in PASI at Week 16 compared to baseline. | Week 16 | 
| Participants With IGA Mod 2011 0 or 1 at 16 Weeks | Investigator's Global Assessment uses a scale (IGA mod 2011) that rates disease from a score of 0 (clear skin) to 4 (severe disease) | Week 16 | 
| Participants Who Achieved Psoriasis Area and Severity Index (PASI) 100 Response at Week 12 | Number of participants who achieved 100% reduction in PASI at Week 12 compared to baseline. | Week 12 | 
| Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16 | Number of participants who achieved ≥ 75% reduction in PASI at Week 16 compared to baseline. | Week 16 | 
| Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 16 | Number of participants who achieved ≥ 90% reduction in PASI at Week 16 compared to baseline. | Week 16 | 
| Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 52 | Number of participants who achieved ≥ 90% reduction in PASI at Week 52 compared to baseline. | Week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Plaque psoriasis, secukinumab, ustekinumab, ain457, ain457a