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A Multicenter, Double-blind, Randomized Withdrawal Extension Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate Long-term Efficacy, Safety, and Tolerability up to 4 Years in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Completing Preceding Psoriasis Phase III Studies With Secukinumab
This was 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) were eligible to join this extension study. This extension study was 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 were used.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Novartis Investigative Site
Birmingham, Alabama, United States
Novartis Investigative Site
Birmingham, Alabama, United States
Novartis Investigative Site
Phoenix, Arizona, United States
Novartis Investigative Site
Phoenix, Arizona, United States
Novartis Investigative Site
Los Angeles, California, United States
Novartis Investigative Site
Oceanside, California, United States
Novartis Investigative Site
Pasadena, California, United States
Novartis Investigative Site
San Diego, California, United States
Novartis Investigative Site
San Diego, California, United States
Novartis Investigative Site
Colorado Springs, Colorado, United States
Start Date
June 19, 2012
Primary Completion Date
June 26, 2017
Completion Date
June 26, 2017
Last Updated
December 20, 2018
1,147
ACTUAL participants
Secukinumab (AIN457)
DRUG
Placebo
DRUG
Lead Sponsor
Novartis Pharmaceuticals
Data Source & Attribution
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