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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01537432
First received: February 17, 2012
Last updated: June 19, 2014
Last verified: June 2014
  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
Endpoint Classification: Safety/Efficacy Study
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:


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 histology response after secukinumab treatment. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Safety and tolerability of secukinumab in patients with chronic psoriasis. [ Time Frame: 64 weeks ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 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:   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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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: June 19, 2014
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
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014