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

Novartis

Status and phase: Completed; Phase 3

Conditions: Chronic Plaque Type Psoriasis

Treatments: Drug: AIN457 300 mg; Drug: ustekinumab 45/90 mg; Drug: placebo secukinumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02074982

2013-003434-32 (EudraCT Number)

CAIN457A2317

Details and patient eligibility

About

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

Enrollment: 676 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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676 participants in 2 patient groups

AIN457 300 mg

Experimental group

Description:

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

Treatment:

Drug: AIN457 300 mg

Ustekinumab

Active Comparator group

Description:

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

Treatment:

Drug: placebo secukinumab

Drug: ustekinumab 45/90 mg