Dose Finding Study for Secukinumab(AIN457) in Moderate to Severe Chronic Plaque-type Psoriasis
- Conditions
- Health Condition 1: null- Plaque- type Psoriasis
- Registration Number
- CTRI/2011/12/002201
- Lead Sponsor
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 918
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.
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 â?¢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 secukinumabTimepoint: â?¢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 â?¢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 secukinumabTimepoint: 12 and 52 weeks