This trial is active, not recruiting.

Condition psoriasis, plaque-type psoriasis
Treatments secukinumab, placebo
Phase phase 2
Sponsor Novartis Pharmaceuticals
Start date January 2012
End date December 2014
Trial size 36 participants
Trial identifier NCT01537432, CAIN457A2223


This study is designed to evaluate the proportion of patients achieving reversal of chronic plaque psoriasis at week 4 and 12 following multiple doses of secukinumab administered subcutaneously (sc) compared to placebo. Starting from week 13, all patients will receive multiple doses of secukinumab up to week 52 to study long term effects of secukinumab. Clinical endpoints including biomarker assessments, PASI, IGA and DLQI will be compared to better understand, why secukinumab may be effective in psoriasis patients.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
(Placebo Comparator)
placebo comparator

Primary Outcomes

Proportion of patients achieving skin histology response after secukinumab treatment.
time frame: 12 weeks

Secondary Outcomes

Proportion of patients achieving skin histology response after secukinumab treatment.
time frame: 52 weeks
Safety and tolerability of secukinumab in patients with chronic psoriasis.
time frame: 64 weeks

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion criteria: - Chronic plaque-type psoriasis diagnosed for at least 6 months - Moderate to severe psoriasis as defined by: PASI score of ≥12, IGA score of ≥3, BSA (body surface area) affected by plaque-type psoriasis of ≥10% - Chronic plaque-type psoriasis considered inadequately controlled by: topical treatment and/or; phototherapy and/or previous systemic therapy Exclusion criteria: - Forms of psoriasis other than chronic plaque-type - Evidence of skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of the investigational product on psoriasis - History or evidence of active tuberculosis or evidence of latent tuberculosis (or other infections like Hepatitis-C/B), malignancy; active or known use of other immunosuppressive drugs (for eg: AIDs, RA, organ rejection etc.) at the screening visit - Pregnant or nursing (lactating) women

Additional Information

Official title Phase II Randomized Double Blinded Placebo Controlled, Multiple-dose Regimen Study to Assess the Rate of Histological Clearance and Effect on Molecular Pathways as Well as on Biomarkers of 12 Months Secukinumab 300 mg s.c. Treated Patients With Chronic Plaque-type Psoriasis
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by Novartis.