Study of Secukinumab Compared to Ustekinumab in Subjects With Plaque Psoriasis

Last updated: June 18, 2019
Sponsor: Novartis Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Psoriasis And Psoriatic Disorders

Warts

Rash

Treatment

N/A

Clinical Study ID

NCT02826603
CAIN457A2326
2015-002898-37
  • Ages > 18
  • All Genders

Study Summary

Demonstrate superiority of secukinumab over ustekinumab in treatment of moderate to severe plaque psoriasis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects must give a written, signed and dated informed consent

  • Chronic plaque-type psoriasis present for at least 6 months before randomization

  • Moderate to severe plaque psoriasis as defined at randomization by:

  • PASI score of ≥12 and

  • Body Surface Area (BSA) affected by plaque-type psoriasis ≥10% and

  • IGA mod 2011 ≥3 (based on a scale of 0-4)

  • Candidate for systemic therapy, defined as having psoriasis inadequately controlledby:

  • Topical treatment (including topical corticosteroids) and/or

  • Phototherapy and/or

  • Previous systemic therapy

Exclusion

Exclusion Criteria:

  • Forms of psoriasis other than plaque psoriasis

  • Drug-induced psoriasis

  • Ongoing use of prohibited treatments

  • Previous exposure to secukinumab or any other biologic drug directly targeting IL-17Aor IL-17RA, or ustekinumab, or any therapies targeting IL-12 or IL-23

  • Use of any other investigational drugs within 5 half-lives of the investigationaltreatment before study drug initiation

  • Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Total Participants: 1114
Study Start date:
June 22, 2016
Estimated Completion Date:
July 09, 2018

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    Winnipeg, Manitoba R3C 1R4
    Canada

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    St. John's, Newfoundland and Labrador A1A 5E8
    Canada

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    Etobicoke, Ontario M8X 1Y9
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    Hamilton, Ontario L8N 1V6
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    Sainte-Hyacinthe, Quebec J2S 66
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    Hradec Kralove, CZE 500 05
    Czechia

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    Praha 10, 100 34
    Czechia

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    Guatemala, 01010
    Guatemala

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    Guatemala City, 01010
    Guatemala

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    Debrecen, 4032
    Hungary

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    Pecs, 7632
    Hungary

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    Szeged, 6725
    Hungary

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    Kopavogur, 201
    Iceland

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    Seongnam, Gyeonggi 13620
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    Bundang Gu, Gyeonggi Do 13620
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    San Antonio, Texas 78229
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    Salt Lake City, Utah 84132
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    Norfolk, Virginia 23507
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    Hanoi, 100000
    Vietnam

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    Ho Chi Minh, 7000
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