Overview

This trial is active, not recruiting.

Condition moderate to severe plaque-type psoriasis
Treatments secukinumab (ain457), placebo
Phase phase 3
Sponsor Novartis Pharmaceuticals
Start date June 2012
End date June 2017
Trial size 1150 participants
Trial identifier NCT01544595, 2012-000533-39, CAIN457A2302E1

Summary

This is an extension study of secukinumab prefilled syringes in subjects with moderate to severe chronic plaque-type psoriasis completing preceding psoriasis phase III studies with secukinumab. Subjects on secukinumab at the end of treatment period in phase III studies (e.g., ongoing CAIN457A2302 and CAIN457A2303 and potentially other secukinumab phase III studies) will be eligible to join this extension study. This extension study is planned to collect an additional 2 years of long-term efficacy, safety, and tolerability data of secukinumab in either continuous or interrupted therapy (randomized withdrawal period) in subjects showing at least partial response to secukinumab and completing treatment period on secukinumab in previous phase III studies. In this extension study, the prefilled syringe (PFS) liquid formulation of secukinumab will be used.

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, investigator)
Primary purpose treatment
Arm
(Placebo Comparator)
PASI 75 responders will participate in "randomized withdrawal". Subjects who were PASI 75 responders at Week 52 visit of the core studies (e.g.CAIN457A2302 or CAIN457A2303) and have been on secukinumab s.c. 150 mg or 300 mg in core studies will be randomized to continue same s.c. doses of secukinumab in PFS or receive placebo every 4 weeks up to Week 152 or until relapse. Randomization in each group will be 2:1. Participants on first full relapse will receive loading dose followed by routine dosing with secukinumab s.c. 150 mg or 300 mg regimen.
secukinumab (ain457)
Secukinumab is a new type of psoriasis medication called a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17). IL-17 is believed to be partly responsible for inflammation (pain, swelling, redness). Researchers believe that IL-17 causes symptoms of plaque-type psoriasis like plaques and scales. A product that targets IL-17 therefore may help to relieve these symptoms and conditions.
placebo
Placebo
(Experimental)
Partial responders are not randomized. Subjects who were partial responders at Week 52 visit in core studies (e.g.CAIN457A2302 or CAIN457A2303) and have been on secukinumab s.c. 150 mg or 300 mg in core studies do not participate in the randomized withdrawal. These subjects will continue same treatment s.c. dose in PFS (secukinumab s.c. 150 mg or 300 mg) as they were receiving at the time of completing the maintenance period (Week 52) in the core studies
secukinumab (ain457)
Secukinumab is a new type of psoriasis medication called a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17). IL-17 is believed to be partly responsible for inflammation (pain, swelling, redness). Researchers believe that IL-17 causes symptoms of plaque-type psoriasis like plaques and scales. A product that targets IL-17 therefore may help to relieve these symptoms and conditions.

Primary Outcomes

Measure
Cumulative rate of subjects with Loss of Psoriasis Area and Severity Index (PASI) 75 response up to Week 68
time frame: At week 68; 16 weeks after week 52

Secondary Outcomes

Measure
Change in Psoriasis Area and Severity Index (PASI)
time frame: Measured throughout the study (for 104 weeks; Week 52 to Week 156) i.e. at Week 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, 136, 140, 144, 148, 152 and 156
Investigator Global Assessment (IGA) 2011 score
time frame: Measured throughout the study (for 104 weeks; Week 52 to Week 156) i.e. at Week 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, 136, 140, 144, 148, 152 and 156
Time to Psoriasis Area and Severity Index (PASI) 75 response, and
time frame: Measured throughout the study (for 104 weeks; Week 52 to Week 156) i.e. at Week 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, 136, 140, 144, 148, 152 and 156
Hemoglobin count, hematocrit count, red blood cell count, white blood cell count with differential(neutrophils including bands, lymphocytes, monocytes, eosinophils, basophils) and platelet count
time frame: Week 52, 64, 76, 88, 104, 116, 128, 140, 156
Electrocardiogram (ECG) test results
time frame: Week 52, 64, 76, 88, 104, 116, 128, 140, 156
Adverse events
time frame: Measured throughout the study (for 104 weeks; Week 52 to Week 156) i.e. at Week 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, 136, 140, 144, 148, 152 and 156
Change in quality of life
time frame: Weeks 52, 64, 76, 88, 104, 116, 128, 140, 156

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion criteria: Completed the full study treatment period of 52 weeks in preceding phase III studies, and have been receiving secukinumab treatment during the maintenance phase of the preceding phase III studies, and show at least a partial response (PASI 50 or better) at Week 52 of the preceding phase III studies. Written informed consent form. Exclusion criteria: A protocol deviation in either of the preceding phase III studies which according to the investigator will prevent the meaningful analysis of the extension study for the individual subject. Ongoing use of prohibited psoriasis or non-psoriasis treatments. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (>10 mIU/mL). Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unwilling to use effective contraception during the study and for 16 weeks after stopping treatment. Other protocol-defined inclusion/exclusion criteria may apply.

Additional Information

Official title A Multicenter, Double-blind, Randomized Withdrawal Extension Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate Long-term Efficacy, Safety, and Tolerability up to 2 Years in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Completing Preceding Psoriasis Phase III Studies With Secukinumab
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Novartis.