Psoriasis Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

36

Study ID:

NCT01537432

Recruitment Status:

Completed

Sponsor:

Novartis Pharmaceuticals

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There are 12 Locations for this study

See Locations Near You

Novartis Investigative Site
Birmingham Alabama, 35205, United States
Novartis Investigative Site
Pasadena California, 91105, United States
Novartis Investigative Site
Indianapolis Indiana, 46256, United States
Novartis Investigative Site
St. Louis Missouri, 63117, United States
Novartis Investigative Site
East Windsor New Jersey, 08520, United States
Novartis Investigative Site
Verona New Jersey, 07044, United States
Novartis Investigative Site
New York New York, 10065, United States
Novartis Investigative Site
Rochester New York, 14623, United States
Novartis Investigative Site
High Point North Carolina, 27262, United States
Novartis Investigative Site
Dallas Texas, 75230, United States
Novartis Investigative Site
Houston Texas, 77030, United States
Novartis Investigative Site
Norfolk Virginia, 23507, United States

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

36

Study ID:

NCT01537432

Recruitment Status:

Completed

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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