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

• ClinicalTrials.gov Identifier: NCT01537432
• Recruitment Status: Completed
• First Posted: February 23, 2012
• Results First Posted: January 5, 2016
• Last Update Posted: January 5, 2016
• Sponsor: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Psoriasis, Plaque-type Psoriasis	Drug: secukinumab; Drug: placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, 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
• Study Start Date: January 2012
• Actual Primary Completion Date: December 2014
• Actual Study Completion Date: December 2014

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: placebo; placebo	Drug: placebo; placebo comparator
Experimental: secukinumab; secukinumab	Drug: secukinumab; secukinumab

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants Achieving Skin Histology Response After Secukinumab Treatment From Baseline to Week 12 [ Time Frame: Baseline, Week 12 ]

   Histological sections of lesional and nonlesional skin biopsies at baseline and at Week 12 were examined. For each visit, each patient's lesional skin biopsy was scored for the degree of histological improvement compared to that patient's baseline disease on a five point scale; -

   1 (worse) to +3 (excellent). Histological disease reversal or "excellent improvement" (histological disease reversal score = 3) was declared at the endpoint when all of the following four criteria were met.

Secondary Outcome Measures :

1. Percentage of Participants Achieving Skin Histological Disease Reversal at Week 52 [ Time Frame: Week 52 ]

   Histological sections of lesional and nonlesional skin biopsies at Week 52 were examined. For each visit, each patient's lesional skin biopsy was scored for the degree of histological improvement compared to that patient's baseline disease on a five point scale; -

   1 (worse) to +3 (excellent). Histological disease reversal or "excellent improvement" (histological disease reversal score = 3) was declared at the endpoint when all of the following four criteria were met.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

United States, Alabama

Novartis Investigative Site

Birmingham, Alabama, United States, 35205

United States, California

Novartis Investigative Site

Pasadena, California, United States, 91105

United States, Indiana

Novartis Investigative Site

Indianapolis, Indiana, United States, 46256

United States, Missouri

Novartis Investigative Site

St. Louis, Missouri, United States, 63117

United States, New Jersey

Novartis Investigative Site

East Windsor, New Jersey, United States, 08520

Novartis Investigative Site

Verona, New Jersey, United States, 07044

United States, New York

Novartis Investigative Site

New York, New York, United States, 10065

Novartis Investigative Site

Rochester, New York, United States, 14623

United States, North Carolina

Novartis Investigative Site

High Point, North Carolina, United States, 27262

United States, Texas

Novartis Investigative Site

Dallas, Texas, United States, 75230

Novartis Investigative Site

Houston, Texas, United States, 77030

United States, Virginia

Novartis Investigative Site

Norfolk, Virginia, United States, 23507

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals; Novartis Pharmaceuticals

More Information

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01537432
• Other Study ID Numbers: CAIN457A2223
• First Posted: February 23, 2012
• Results First Posted: January 5, 2016
• Last Update Posted: January 5, 2016
• Last Verified: November 2015

Keywords provided by Novartis ( Novartis Pharmaceuticals ):

Psoriasis, Plaque-type psoriasis; Plaque; Secukinumab; AIN457A; PASI; DLQI; IGA

Additional relevant MeSH terms:

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases