This trial is active, not recruiting.

Condition moderate to severe chronic plaque-type psoriasis
Treatment ain457
Phase phase 3
Sponsor Novartis Pharmaceuticals
Start date September 2012
End date May 2017
Trial size 675 participants
Trial identifier NCT01640951, 2012-000985-39, CAIN457A2304E1


CAIN457A2304E1 is an extension study to two ongoing phase III studies, CAIN457A2304 and CAIN457A2307 (core studies). This extension study is planned to collect up to two years of long-term safety, tolerability and efficacy data of secukinumab in both the fixed interval regimen and the retreatment at start of relapse regimen. All subjects completing Week 52 of CAIN457A2304 and Week 40 of CAIN457A2307 will be eligible to participate in this extension study. Week 40 of the CAIN457A2307 study is the end of maintenance visit (EOM) and is equivalent to the Week 52 (EOM) of the CAIN457A2304 core study. Therefore, all subjects entering the CAIN457A2304E1 study will have received 52 weeks of treatment in their previous study / 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 non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
150 mg s.c. secukinumab in PFS
Start of Relapse either 150 mg s.c. secukinumab in PFS
300 mg s.c. secukinumab in PFS
Start of Relapse either 300 mg s.c. secukinumab in PFS
Open Lable secukinumab 300mg

Primary Outcomes

The number and percentage of subjects having any AE
time frame: 104 weeks

Secondary Outcomes

Change in PASI 75 responses
time frame: Week 92, Week 104, Week 144, Week 156
Investigator Global Asessment (IGA) Response
time frame: week 104
Change in Quality of Life Response
time frame: Baseline, week 104

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study related activity is performed. Where relevant, a legal representative will also sign the informed consent according to local laws and regulations. 2. Subjects who complete Week 52 of study CAIN457A2304 or complete Week 40 of study CAIN457A2307 3. Subjects expected to benefit from participation in the extension study, as assessed by the subject and investigator Exclusion Criteria: 1. A protocol deviation in the core studies which according to the investigator will prevent the meaningful analysis of the extension study for the individual subject 2. Ongoing use of prohibited psoriasis or non-psoriasis treatments. Time period from last use of prohibited treatments in the core study to first dose of study drug in this extension study. 3. Subjects expected to be exposed to an undue safety risk if participating in the trial 4. Current severe progressive or uncontrolled disease which in the judgment of the investigator renders the subject unsuitable for the trial 5. Plans for administration of live vaccines during the study period 6. 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).

Additional Information

Official title Extension Study of Secukinumab Prefilled Syringes in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Completing Preceding Secukinumab Phase III Studies
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Novartis.