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

Purpose

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.

Condition	Intervention	Phase
Psoriasis, Plaque-type Psoriasis	Drug: secukinumab Drug: placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Proportion of patients achieving skin histology response after secukinumab treatment. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of patients achieving skin improvements as measured by PASI (Psoriasis Area and Severity Index) scores. [ Time Frame: 46 weeks-76 weeks ] [ Designated as safety issue: No ]
Skin response as measured by Investigator Global Assessment scores and Changes in Dermatology Life Quality Index (DLQI) throughout the trial [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Number of patients with clinical and laboratory adverse experience, immunogenicity and concentration of biomarkers [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	36
Study Start Date:	January 2012
Estimated Study Completion Date:	April 2014
Estimated Primary Completion Date:	April 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: placebo placebo	Drug: placebo placebo comparator
Experimental: secukinumab secukinumab	Drug: secukinumab secukinumab

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01537432

Contacts

Contact: Novartis Pharmaceuticals

862-778-8300

Locations

United States, California
Novartis Investigative Site	Not yet recruiting
Pasadena, California, United States, 91105
United States, Indiana
Novartis Investigative Site	Not yet recruiting
Indianapolis, Indiana, United States, 46256
United States, Missouri
Novartis Investigative Site	Recruiting
St. Louis, Missouri, United States, 63117
United States, New Jersey
Novartis Investigative Site	Recruiting
East Windsor, New Jersey, United States, 08520
Novartis Investigative Site	Recruiting
Verona, New Jersey, United States, 07044
United States, New York
Novartis Investigative Site	Not yet recruiting
New York, New York, United States, 10021
Novartis Investigative Site	Not yet recruiting
Rochester, New York, United States, 14623
United States, North Carolina
Novartis Investigative Site	Recruiting
High Point, North Carolina, United States, 27262
United States, Texas
Novartis Investigative Site	Recruiting
Dallas, Texas, United States, 75230
Novartis Investigative Site	Not yet recruiting
Houston, Texas, United States, 77030
United States, Virginia
Novartis Investigative Site	Not yet recruiting
Norfolk, Virginia, United States, 23507

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT01537432 History of Changes
Other Study ID Numbers:	CAIN457A2223
Study First Received:	February 17, 2012
Last Updated:	October 1, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Psoriasis, Plaque-type psoriasis
Plaque
Secukinumab
AIN457A

PASI
DLQI
IGA

Additional relevant MeSH terms:

Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on May 21, 2013