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

Conditions

• Psoriasis, Plaque-type Psoriasis

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• secukinumab — DRUG
  secukinumab
• placebo — DRUG
  placebo comparator

Study Details

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.

Key Dates

Start date

Jan 31, 2012

Status verified

Nov 2015

Primary completion

Dec 31, 2014

Completion

Dec 31, 2014

Study Design

Enrollment

36 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: placebo
  placebo
• Experimental: secukinumab
  secukinumab

Primary Outcome Measure

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

Locations (12)

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