Study of Efficacy and Safety of Secukinumab in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis

Novartis

Status and phase: Completed; Phase 3

Conditions: Plaque Psoriasis

Treatments: Drug: Secukinumab 150 mg s.c.; Drug: Secukinumab 300 mg s.c.; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03066609

CAIN457A2318

Details and patient eligibility

About

The purpose of this study was to determine if secukinumab is effective and safe in the treatment of plaque type psoriasis

Enrollment: 543 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects must give a written, signed and dated informed consent.

2. Men or women at least 18 years of age at time of screening.

3. Chronic plaque-type psoriasis present for at least 6 months and diagnosed before Baseline.

4. Moderate to severe psoriasis as defined at Baseline by:

   • PASI score of 12 or greater, and
   • IGA mod 2011 score of 3 or greater (based on a static scale of 0 - 4), and
   • Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater.

5. Candidate for systemic therapy. This is defined as a subject having moderate to severe chronic plaque-type psoriasis that is inadequately controlled by

   • topical treatment and/or,
   • phototherapy and/or,
   • previous systemic therapy.

Exclusion criteria

1. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at Screening or Baseline.
2. Drug-induced psoriasis.
3. Ongoing use of prohibited treatments.
4. Previous exposure to secukinumab (AIN457) or any other biologic drug directly targeting IL-17 or the IL-17 receptor.
5. Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days until the expected pharmacodynamic effect has returned to baseline, whichever is longer; or longer if required by local regulations.
6. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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543 participants in 3 patient groups, including a placebo group

Secukinumab 150mg

Experimental group

Description:

Secukinumab 150mg s.c.

Treatment:

Drug: Secukinumab 150 mg s.c.

Secukinumab 300mg

Experimental group

Description:

Secukinumab 300mg s.c.

Treatment:

Drug: Secukinumab 300 mg s.c.

Placebo

Placebo Comparator group

Description:

Placebo to secukinumab s.c

Treatment:

Drug: Placebo