Dose Finding Study for Secukinumab(AIN457) in Moderate to Severe Chronic Plaque-type Psoriasis

Phase 3

Completed

• Conditions: Plaque- type Psoriasis

• Registration Number: CTRI/2011/12/002201
• Lead Sponsor: Novartis Healthcare Pvt Ltd

Brief Summary

Brief Summary:

Purpose of the study:  This study will assess the safety and efficacy of two different doses and two different dose regimens of subcutaneous secukinumab in patients that have moderate to severe, chronic, plaque-type psoriasis.

FPFV for India:20-Dec-2011

Enrollment Target for India:95

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-20
• Last Update Posted: 2013-01-03

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 918

Inclusion Criteria

• Moderate and severe plaque-type psoriasis diagnosed for at least 6 months.
• Severity of disease meeting all of the following three criteria: PASI score of 12 or greater, Investigators Global Assessment (IGA) score of 3 or greater Total body surface area (BSA) affected of 10 percent or greater.
• Inadequate control by prior use of topical treatment, phototherapy and or systemic therapy.

Exclusion Criteria

• Current forms of psoriasis other than chronic plaque-type psoriasis (for example, pustular, erythrodermic, guttate).
• Current drug-induced psoriasis.
• Previous use of secukinumab or any drug that targets IL-17 or IL-17 receptor.
• Significant medical problems such as uncontrolled hypertension, congestive heart failure or a condition that significantly immunocompromises the subject.
• Hematological abnormalities.
• History of an ongoing, chronic or recurrent infectious disease, or evidence of untreated tuberculosis.
• History of lymphoproliferative disease or history of malignancy of any organ system within the past 5 years.
• Pregnant or nursing (lactating) women.
• Other protocol-defined inclusion or exclusion criteria may apply.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•Proportion of subjects who maintain Psoriasis Area and Severity Index 75 (PASI 75) response relative to baseline after having achieved PASI 75 response after 12 weeks of treatment with secukinumab	•Proportion of subjects who maintain Psoriasis Area and Severity Index 75 (PASI 75) response relative to baseline after having achieved PASI 75 response after 12 weeks of treatment with secukinumab

Secondary Outcome Measures

Name	Time	Method
•Proportion of subjects who achieve PASI 50/75/90/100 response or Investigators Global Assessment (IGA) 0 or 1 response relative to baseline after 12 weeks and after 52 weeks of treatment with secukinumab	12 and 52 weeks

Trial Locations

Locations (9)

A J Institute of Medical Sciences; 🇮🇳 Bangalore, KARNATAKA, India

Dr. Vikrant Saoji Skin Clinic; 🇮🇳 Nagpur, MAHARASHTRA, India

Gandhi Hospital; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Grant Medical college and JJ Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

M.S. Ramaiah Memorial Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Owaisi Hospital and research centre; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Radiance skin clinic; 🇮🇳 Nagpur, MAHARASHTRA, India

Shree Hospital & critical care,; 🇮🇳 Nagpur, MAHARASHTRA, India

Skin Clinic; 🇮🇳 Nashik, MAHARASHTRA, India

A J Institute of Medical Sciences

🇮🇳Bangalore, KARNATAKA, India

Dr Narendra Shetty

Principal investigator

919945613123

drnarendrashetty@yahoo.com