Overview

This trial is active, not recruiting.

Condition plaque-type psoriasis
Treatments placebo, secukinumab 150mg, secukinumab 300mg
Phase phase 3
Sponsor Novartis Pharmaceuticals
Start date October 2012
End date October 2016
Trial size 182 participants
Trial identifier NCT01636687, 2012-002609-22, CAIN457A2309

Summary

The purpose of this study is to demonstrate efficacy of autoinjector administered 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
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Subjects who were at placebo at Week 52 cannot continue in the extension treatment period
placebo
2 injections of placebo to secukinumab 150mg per dose
(Experimental)
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
secukinumab 150mg
Secukinumab 150mg: 1 injection of 150 mg secukinumab and 1 injection of placebo to secukinumab 150mg per dose. After Week 52 database lock, study is open label so only 1 injection of secukinumab 150mg per dose will be administered
(Experimental)
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
secukinumab 300mg
Secukinumab 300mg (2 injections of 150mg secukinumab per dose)

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) and investigator / site staff observation
time frame: Week 0- Week 48
Psoriasis Area and Severity Index (PASI) 50 / 75 / 90 / 100 and IGA 0 or 1 response
time frame: up to Week 12, and over time up to Week 52
Clinical safety and tolerability of secukinumab
time frame: up to Week 12, and over time up to Week 52
Efficacy of secukinumab with respects to the EQ-5D score
time frame: up to Week 12, and over time up to Week 52
Efficacy of secukinumab with respects to the DLQI
time frame: up to Week 12, and over time up to Week 52
Efficacy of secukinumab with respects to DLQI 0 or 1
time frame: up to Week 12, and over time up to Week 52
Secukinumab immunogenicity
time frame: up to Week 12, and over time up to Week 52
PASI 50 / 75 / 90 / 100 and IGA 0 or 1 response, after Week 52
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 - Other protocol-defined inclusion/exclusion criteria may apply.

Additional Information

Official title A Randomized, Double-blind, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab in Autoinjectors 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 August 2016.
Information provided to ClinicalTrials.gov by Novartis.