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Multiple-dose Regimen Study to Assess Effect of 12 Months of Secukinumab Treatment on Skin Response and Biomarkers in Psoriasis Patients | Clinical Trials | Clareo Health

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Multiple-dose Regimen Study to Assess Effect of 12 Months of Secukinumab Treatment on Skin Response and Biomarkers in Psoriasis Patients

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

NCT01537432•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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

Locations (12)

Novartis Investigative Site

Birmingham, Alabama, United States

Novartis Investigative Site

Pasadena, California, United States

Novartis Investigative Site

Indianapolis, Indiana, United States

Novartis Investigative Site

St Louis, Missouri, United States

Novartis Investigative Site

East Windsor, New Jersey, United States

Novartis Investigative Site

Verona, New Jersey, United States

Novartis Investigative Site

New York, New York, United States

Novartis Investigative Site

Rochester, New York, United States

Novartis Investigative Site

High Point, North Carolina, United States

Novartis Investigative Site

Dallas, Texas, United States

Key Dates

Start Date

January 1, 2012

Primary Completion Date

December 1, 2014

Completion Date

December 1, 2014

Last Updated

January 5, 2016

Enrollment

ACTUAL participants

Conditions

Psoriasis, Plaque-type Psoriasis

Interventions

secukinumab

DRUG

placebo

DRUG