Efficacy of Secukinumab Compared to Ustekinumab in Patients With Plaque-type Psoriasis

Phase 3

Completed

• Conditions: Chronic Plaque Type Psoriasis
• Interventions: Drug: AIN457 300 mg; Drug: ustekinumab 45/90 mg; Drug: placebo secukinumab

• Registration Number: NCT02074982
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This study assessed efficacy of secukinumab, compared to ustekinumab, in patients that have plaque-type psoriasis

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-26
• Study First Submitted: 2014-02-27
• Study First Submitted QC: 2014-02-28
• Study First Posted: 2014-03-03
• Primary Completion: 2016-06-29
• Study Completion: 2016-06-29
• Status Verified: 2017-06
• Results First Submitted: 2017-06-23
• Results First Submitted QC: 2017-06-23
• Last Update Submitted: 2017-06-23
• Results First Posted: 2017-07-21
• Last Update Posted: 2017-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 676

Inclusion Criteria

• patients with moderate to severe plaque type psoriasis for at least 6 months before randomization
• patients eligible for systemic therapy with inadequately controlled psoriasis

Exclusion Criteria

• forms of sporiasis other than plaque type psoriasis
• previous exposure to secukinumab, ustekinumab, or other biologic drugs targeting (IL)-17A or IL-17RA

Other protocol-defined inclusion/exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AIN457 300 mg	AIN457 300 mg	patients received AIN457 (secukinumab) 300 mg (two secukinumab 150 mg injections) s.c. (subcutaneously) once every week at weeks 0, 1,2,3, followed by monthly dosing starting at week 4 to week 48 inclusive
Ustekinumab	ustekinumab 45/90 mg	patients received ustekinumab 45/90 mg (weight depended, according to label) s.c. (subcutaneously) and/or placebo secukinumab injections once every week at weeks 0,1,2, and 3 followed by monthly dosing starting at week 4 to week 48 inclusive
Ustekinumab	placebo secukinumab	patients received ustekinumab 45/90 mg (weight depended, according to label) s.c. (subcutaneously) and/or placebo secukinumab injections once every week at weeks 0,1,2, and 3 followed by monthly dosing starting at week 4 to week 48 inclusive

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 16	Week 16	Psoriasis Area and Severity Index (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).; PASI 90 responders were defined as participants achieving ≥ 90% improvement at Week 16

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 52	Week 52	Psoriasis Area and Severity Index (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).; PASI 90 responders were defined as participants achieving ≥ 90% improvement at Week 52
Speed of Onset Based on the Percentage of Participents Achieving PASI 75 at Week 4	Week 4	Psoriasis Area and Severity Index (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).; Speed of Onset was based on percentage PASI 75 responders and were defined as participants achieving ≥ 75% improvement at Week 4

Trial Locations

Locations (1)

Novartis Investigative Site; 🇬🇧 Stoke-on-Trent, United Kingdom