First Study of Secukinumab in Pre-filled Syringes in Subjects With Chronic Plaque-type Psoriasis: Response at 12 Weeks (FEATURE)

Novartis

Status and phase: Completed; Phase 3

Conditions: Moderate to Severe Plaque-type Psoriasis

Treatments: Drug: placebo; Drug: secukinumab 150 mg; Drug: secukinumab 300 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01555125

CAIN457A2308

2011-006057-28 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to demonstrate efficacy of secukinumab at Week 12 based on PASI and IGA response rates versus placebo in subjects with moderate to severe chronic plaque-type psoriasis.

Enrollment: 177 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 psoriasis disease meeting all of the following three criteria:

Psoriasis Area and Severity Index (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: Double Blind

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177 participants in 3 patient groups, including a placebo group

secukinumab 150 mg

Experimental group

Description:

Drug

Treatment:

Drug: secukinumab 150 mg

secukinumab 300 mg

Experimental group

Description:

Drug

Treatment:

Drug: secukinumab 300 mg

placebo

Placebo Comparator group

Treatment:

Drug: placebo