Efficacy and Safety of Subcutaneous Secukinumab (AIN457) for Moderate to Severe Chronic Plaque-type Psoriasis Assessing Different Doses and Dose Regimens (SCULPTURE)

Novartis

Status and phase: Completed; Phase 3

Conditions: Moderate to Severe Plaque-type Psoriasis

Treatments: Drug: AIN457 300mg; Drug: AIN457 150mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01406938

2011-000767-27 (EudraCT Number)

CAIN457A2304

Details and patient eligibility

About

This study will assess the safety and efficacy of two different doses and two different dose regimens of subcutaneous secukinumab in patients that have moderate to severe, chronic, plaque-type psoriasis.

Enrollment: 967 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Moderate and severe plaque-type psoriasis diagnosed for at least 6 months.

Severity of disease meeting all of the following three criteria:

• PASI score of 12 or greater,
• Investigator's Global Assessment (IGA) score of 3 or greater
• Total body surface area (BSA) affected of 10% or greater.
• Inadequate control by prior use of topical treatment, phototherapy and/or systemic therapy.

Exclusion criteria

• Current forms of psoriasis other than chronic plaque-type psoriasis (for example, pustular, erythrodermic, guttate).
• Current drug-induced psoriasis.
• Previous use of secukinumab or any drug that targets IL-17 or IL-17 receptor.
• Significant medical problems such as uncontrolled hypertension, congestive heart failure or a condition that significantly immunocompromises the subject.
• Hematological abnormalities.
• History of an ongoing, chronic or recurrent infectious disease, or evidence of untreated tuberculosis.
• History of lymphoproliferative disease or history of malignancy of any organ system within the past 5 years.
• Pregnant or nursing (lactating) women.
• 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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967 participants in 6 patient groups

AIN457150 mg- Induction period Only(IPO)

Experimental group

Description:

secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)

Treatment:

Drug: AIN457 150mg

AIN457 300 mg - IPO

Experimental group

Description:

secukinumab- 2 x 150mg injections per dose

Treatment:

Drug: AIN457 300mg

AIN457 150 mg - Fixed Interval (FI)

Experimental group

Description:

1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection

Treatment:

Drug: AIN457 150mg

AIN457 300 mg FI

Experimental group

Description:

2 s.c. secukinumab 150 mg injections

Treatment:

Drug: AIN457 300mg

AIN457 150 mg- Start of relapse (SoR)

Experimental group

Description:

1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection

Treatment:

Drug: AIN457 150mg

AIN457 300 mg- SoR

Experimental group

Description:

2 s.c. secukinumab 150 mg injections

Treatment:

Drug: AIN457 300mg