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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01537432
First received: February 17, 2012
Last updated: December 1, 2015
Last verified: November 2015

February 17, 2012
December 1, 2015
January 2012
December 2014   (final data collection date for primary outcome measure)
Percentage of Participants Achieving Skin Histology Response After Secukinumab Treatment From Baseline to Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]

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.

Proportion of patients achieving skin histology response after secukinumab treatment. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01537432 on ClinicalTrials.gov Archive Site
Percentage of Participants Achieving Skin Histological Disease Reversal at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]

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.

  • 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 ]
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Psoriasis, Plaque-type Psoriasis
  • Drug: secukinumab
    secukinumab
  • Drug: placebo
    placebo comparator
  • Placebo Comparator: placebo
    placebo
    Intervention: Drug: placebo
  • Experimental: secukinumab
    secukinumab
    Intervention: Drug: secukinumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01537432
CAIN457A2223
No
Not Provided
Not Provided
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP