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

A Randomized, Double-blind, Multicenter Study of Subcutaneous Secukinumab, Assessing Psoriasis Area and Severity Index (PASI) Response and Maintenance of Response in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis on Either a Fixed Dose Regimen or on a Retreatment at Start of Relapse Regimen - SCULPTURE

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/12/002201

Enrollment

918

Registered

2011-12-05

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Plaque- type Psoriasis

Interventions

Intervention1: Experimental:(fixed interval treatment):Secukinumab 150 mg: secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose) 1 sub-cutaneous secukinuma

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

Austria, Bulgaria, Canada, Czech Republic, France, Germany, India, Italy, Japan, Poland, Singapore, Slovakia, Switzerland, United Kingdom, United States of America, Viet Nam

Contacts

Public ContactMurugananthan K

Novartis Healthcare Private Limited

murugananthan.k@novartis.com022-24958545

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026