Study of Secukinumab Compared to Ustekinumab in Subjects With Plaque Psoriasis

Phase 3

Completed

Conditions: Plaque Psoriasis

Interventions: Drug: Secukinumab
Drug: Ustekinumab

Registration Number: NCT02826603

Lead Sponsor: Novartis Pharmaceuticals

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1114

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Secukinumab	Secukinumab	Secukinumab
Ustekinumab	Ustekinumab	Ustekinumab

Primary Outcome Measures

Name	Time	Method
Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 12	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).
Participants With IGA Mod 2011 0 or 1 at Week 12	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)

Secondary Outcome Measures

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