Safety and Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe, Chronic Plaque-Type Psoriasis

Last updated: December 9, 2020
Sponsor: Novartis Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Psoriasis And Psoriatic Disorders

Warts

Rosacea

Treatment

N/A

Clinical Study ID

NCT01358578
CAIN457A2303
2010-022228-66
  • Ages > 18
  • All Genders

Study Summary

This study will assess the safety and efficacy of secukinumab compared to placebo and etanercept in patients that have moderate to severe, chronic, plaque-type psoriasis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects with chronic, plaque-type psoriasis for at least 6 months
  • Must have moderate to severe psoriasis based on PASI greater than 12, IGA greater than 3, and greater than 10% body surface area
  • Must be inadequately controlled by prior treatments (topicals, phototherapy, and/orsystemic therapies)

Exclusion

Exclusion Criteria:

  • Forms of psoriasis other than chronic, plaque-type (such as pustular, erythrodermicand guttate psoriasis)
  • Drug induced psoriasis
  • Use of other psoriasis treatments during the study
  • Prior use of etanercept
  • Prior use of secukinumab or any other drug that target IL-17 (interleukin 17) or theIL-17 receptor
  • Pregnant or lactating women; women who do not agree to use contraception during thestudy and for 16 weeks after stopping treatment
  • Significant medical problems such as uncontrolled high blood pressure, congestiveheart failure, etc.
  • History of an ongoing, chronic or recurrent infection or evidence of tuberculosis
  • Allergy to rubber or latex Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Total Participants: 1306
Study Start date:
June 01, 2011
Estimated Completion Date:
July 31, 2013

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