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

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis, Plaque-type Psoriasis
• Intervention / Treatment: Drug: placebo; Drug: secukinumab

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Drug: placebo; placebo comparator
Experimental: secukinumab	Drug: secukinumab; secukinumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Skin Histology Response After Secukinumab Treatment From Baseline to 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.	Baseline, Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving Skin Histological Disease Reversal at 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.	Week 52

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: February 17, 2012
• First Submitted That Met QC Criteria: February 17, 2012
• First Posted (Estimate): February 23, 2012

Study Record Updates

• Last Update Posted (Estimate): January 5, 2016
• Last Update Submitted That Met QC Criteria: December 1, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: PASI; DLQI; IGA; Plaque; Secukinumab; AIN457A; Psoriasis, Plaque-type psoriasis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: CAIN457A2223