Efficacy and Safety of Intravenous and Subcutaneous Secukinumab in Moderate to Severe Chronic Plaque-type Psoriasis (STATURE)

Novartis

Status and phase: Completed; Phase 3

Conditions: Plaque-type Psoriasis

Treatments: Drug: secukinumab 10mg/kg i.v. regimen; Drug: secukinumab 150mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01412944

2011-002510-36 (EudraCT Number)

CAIN457A2307

Details and patient eligibility

About

The study will assess the safety and efficacy of intravenous (10mg/kg) and subcutaneous (300mg) secukinumab in moderate to severe chronic plaque-type psoriasis who are partial responders to secukinumab.

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

• Written Informed Consent must be obtained before any assessment is performed,
• Subject must be able to understand and communicate with the investigator and comply with the requirements of the study.
• Subjects must have participated in the study CAIN457A2304 and have achieved a partial response after twelve weeks of treatment with no major protocol deviations.

A partial response is defined as having achieved ≥ PASI 50 but < 75 response.

Exclusion criteria

• Pregnant women or lactating women
• Forms of psoriasis other than chronic plaque -type
• Ongoing use of prohibited psoriasis treatments
• Ongoing use of other non-psoriasis prohibited treatments
• Previous exposure to any biologic drug directly targeting IL-17 or the IL-17 receptor, except secukinumab in study CAIN457A2304
• Active ongoing inflammation diseases other than psoriasis that might confound the evaluation of the benefits of secukinumab therapy
• UV therapy or excessive exposure to sunlight

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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43 participants in 2 patient groups

AIN457 subcutaneous (s.c.)

Experimental group

Description:

During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.

Treatment:

Drug: secukinumab 150mg

AIN457 I.V.

Experimental group

Description:

During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.

Treatment:

Drug: secukinumab 10mg/kg i.v. regimen