Overview

This trial is active, not recruiting.

Condition plaque-type psoriasis
Treatments ain457, placebo
Phase phase 2
Sponsor Novartis Pharmaceuticals
Start date May 2010
End date May 2017
Trial size 276 participants
Trial identifier NCT01132612, 2009-017234-51, CAIN457A2211E1

Summary

The purpose of this study is to provide long term clinical data for the compound for the treatment of the indication of 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)
Fixed-time interval regimen
ain457
secukinumab
ain457
secukinumab
ain457
secukinumab
(Experimental)
Treatment at start of relapse regimen
ain457
secukinumab
ain457
secukinumab
ain457
secukinumab
(Experimental)
Open-label
ain457
secukinumab
ain457
secukinumab
ain457
secukinumab
(Placebo Comparator)
Placebo
placebo
placebo

Primary Outcomes

Measure
Safety and tolerability as measured by the number of patients with Adverse Events and clinically significant changes in vital signs and clinical laboratory variables.
time frame: 81 +157 (prolongation) weeks

Secondary Outcomes

Measure
Long-term efficacy as assessed by the number of patients with a PASI 50, PASI 75 and PASI 90 achievement and an improvement of the Investigator' global assessment score during the trial.
time frame: 81 +157 (prolongation) weeks
To evaluate the long-term immunogenicity by measuring the number of patients developing anti AIN antibodies during the trial.
time frame: 81 +157 (prolongation) weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients who completed the core study CAIN457A2211. A patient is defined as having completed the core study if he/she completed the study up to and including visit 13 (F4) of the core study - Patients must be able to understand and communicate with the investigator and comply with the requirement of the study and must given written, signed and dated informed consent before any study assessment is performed. - Patients must be expected to benefit from the ongoing treatment with AIN457, as assessed by the patient and investigator - Male patients must consent to practice reliable contraception during the study and for 16 weeks after the last dose of study drug administration Exclusion Criteria: - Patients who experience a second consecutive full relapse at visit 13 ( week F4) of the core study CAIN457A2211 - Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until termination of gestation, confirmed by a positive hCG laboratory test (> 5mlU/mL) - Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, UNLESS they are: - women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner - women whose partners have been sterilized by vasectomy or other means - using a highly effective method of birth control (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, condoms (by the partner) and some intrauterine devices (IUDs); Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) are not acceptable Other protocol-defined inclusion/exclusion criteria may apply

Additional Information

Official title A Multicenter Extension Trial of Subcutaneously Administered AIN457 in Patients With Moderate to Severe Chronic Plaque-type Psoriasis
Description The purpose of this study is to provide long term clinical data for the compound for the treatment of the indication of moderate to severe chronic plaque-type psoriasis. In the Proof-of-Concept study (CAIN457A2102), AIN457 has proven to be efficacious in the treatment of moderate to severe chronic plaque-type psoriasis. As a result, a phase IIb regimen finding study has been started (CAIN457A2211). The data gathered in this extension study of the core study (CAIN457A2211) will be used to expand the safety database of the compound for the treatment of moderate to severe chronic plaque-type psoriasis. The patients in the extension study will continue to stay on the exact same treatment regimen they were taking when completing the core study.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Novartis.