Overview

This trial is active, not recruiting.

Condition moderate to severe plaque-type psoriasis
Treatments secukinumab 150 mg, secukinumab 300 mg, placebo
Phase phase 3
Sponsor Novartis Pharmaceuticals
Start date May 2012
End date December 2016
Trial size 177 participants
Trial identifier NCT01555125, 2011-006057-28, CAIN457A2308

Summary

The purpose of this study is to demonstrate efficacy of secukinumab at Week 12 based on PASI and IGA response rates versus placebo in subjects with moderate to severe chronic plaque-type psoriasis.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
Drug
secukinumab 150 mg
After the data base lock of week 52 data has been performed, subjects will receive secukinumab 150 mg treatment as open label for the remainder of the extension treatment period
(Experimental)
Drug
secukinumab 300 mg
After the data base lock of week 52 data has been performed, subjects will receive secukinumab 300 mg treatment as open label for the remainder of the extension treatment period
(Placebo Comparator)
placebo
Subjects who were on placebo at Week 52 cannot continue in the extension treatment period

Primary Outcomes

Measure
Psoriasis Area and Severity Index (PASI) 75 score and Investigators' Global Assessment (IGA) with 0 or 1 response
time frame: 12 weeks

Secondary Outcomes

Measure
Self-administered Self-Injection Assessment Questionnaire (SIAQ) score and investigator / site staff observation
time frame: Week 0 - Week 48
PASI score 50 / 75 / 90 / 100 and IGA 0 or 1 response
time frame: up to Week 12, and over time up to Week 52
PASI 50 / 75 / 90 / 100 and IGA 0 or 1 response
time frame: after Week 52
PASI score and IGA mod 2011 score after Week 52
time frame: after Week 52
Long term clinical safety and tolerability of secukinumab
time frame: after Week 52

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion criteria: - Moderate and severe plaque-type psoriasis diagnosed for at least 6 months. - Severity of psoriasis disease meeting all of the following three criteria: Psoriasis Area and Severity Index (PASI) score of 12 or greater, Investigator's Global Assessment (IGA) score of 3 or greater, Total body surface area (BSA) affected of 10% 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/exclusion criteria may apply

Additional Information

Official title A Randomized, Double-blind, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate Efficacy After Twelve Weeks of Treatment, and to Assess the Safety, Tolerability, Usability and Long-term Efficacy in Subjects With Chronic Plaque-type Psoriasis
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Novartis.