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

Phase 2

Completed

• Conditions: Psoriasis, Plaque-type Psoriasis
• Interventions: Drug: placebo; Drug: secukinumab

• Registration Number: NCT01537432
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-02-17
• Study First Submitted QC: 2012-02-17
• Study First Posted: 2012-02-23
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-11
• Results First Submitted: 2015-12-01
• Results First Submitted QC: 2015-12-01
• Last Update Submitted: 2015-12-01
• Results First Posted: 2016-01-05
• Last Update Posted: 2016-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	placebo
secukinumab	secukinumab	secukinumab

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Skin Histology Response After Secukinumab Treatment From Baseline to Week 12	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

Name	Time	Method
Percentage of Participants Achieving Skin Histological Disease Reversal at Week 52	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.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇺🇸 Norfolk, Virginia, United States