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Clinical trial

Extension Study of Secukinumab Prefilled Syringes in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Completing Preceding Psoriasis Phase III Studies With Secukinumab

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Last updated:19th Jun 2012
Source: Clinical Trials
Identifier: NCT01544595

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.

Primary Outcome Measures:
  • 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 ]
    Efficacy of secukinumab in subjects with moderate to severe chronic plaque-type psoriasis
 
Secondary Outcome Measures:
  • 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 ]
    measured in degrees
  • 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 ]
    percentage of patients with any adverse events
  • Change in quality of life [ Time Frame: Weeks 52, 64, 76, 88, 104, 116, 128, 140, 156 ]
    Change in EQ-5D©, DLQI© and HAQ©-DI scores
Category Value
Date last updated at source 2017-04-20
Study type(s) Interventional
Expected enrolment 1150
Study start date 2012-06-19
Estimated primary completion date 2017-06-26

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