Study of Secukinumab Compared to Fumaderm® in Adults With Moderate to Severe Psoriasis.

Last updated: June 11, 2017
Sponsor: Novartis Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Warts

Scalp Disorders

Rosacea

Treatment

N/A

Clinical Study ID

NCT02474082
CAIN457ADE06
  • Ages > 18
  • All Genders

Study Summary

This is a randomized, controlled, multicenter, open-label study with blinded assessment of the efficacy of subcutaneous secukinumab compared to Fumaderm®, in 200 adults with moderate to severe plaque type psoriasis who are candidates for systemic therapy. The study consists of 2 periods: a screening period of at least one week and up to four weeks, and a treatment period of 24 weeks. During the screening period eligibility of the patients is confirmed. Eligible patients are randomized 1:1 to treatment arm A or B at week 0. Patients in treatment arm A receive secukinumab administered at weeks 0, 1, 2, 3, 4, 8, 12, 16 and 20 and are followed up for assessments of the study endpoints until week 24. Patients in treatment arm B receive daily doses of Fumaderm® p.o.. Safety and efficacy measurements of secukinumab and Fumaderm® will be performed throughout the study and up to week 24.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Men or women must be at least 18 years of age at the time of screening

  • Chronic plaque-type psoriasis diagnosed for at least 6 months before randomization Patients with moderate to severe plaque psoriasis who are candidates for systemic therapy as defined at randomization by:

  • PASI score of >10

  • Affected body surface area (BSA) > 10%

  • DLQI >10

  • Inadequate response, intolerance or contraindication to topical psoriasis treatment as documented in the patient's medical history or reported by the patient or determined by the investigator at screening.

Exclusion Criteria (abbreviated):

  • Previous systemic treatment of plaque psoriasis or known contraindication for systemic therapy at baseline

  • Ongoing use of other prohibited psoriasis and non-psoriasis treatment.

  • Clinically important active infections or infestations, chronic, recurrent or latent infections or infestations

  • Patients with severe liver diseases

  • Patients with severe gastrointestinal diseases including but not limited to ventricular and duodenal ulcers

  • Patients with severe kidney diseases or serum creatinine above 1 x ULN

  • Patients with known hematological disease or lab abnormalities

  • Pregnancy, breast feeding, or unwillingness/inability to use appropriate measures of contraception (if necessary)

Study Design

Total Participants: 202
Study Start date:
April 01, 2015
Estimated Completion Date:
June 30, 2016

Connect with a study center

  • Novartis Investigative Site

    Bad Bentheim, 48455
    Germany

    Site Not Available

  • Novartis Investigative Site

    Berlin, 10789
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bielefeld, 33647
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bochum, 44791
    Germany

    Site Not Available

  • Novartis Investigative Site

    Bonn, 53105
    Germany

    Site Not Available

  • Novartis Investigative Site

    Darmstadt, 64283
    Germany

    Site Not Available

  • Novartis Investigative Site

    Dresden, 01307
    Germany

    Site Not Available

  • Novartis Investigative Site

    Erlangen, 91054
    Germany

    Site Not Available

  • Novartis Investigative Site

    Essen, 45147
    Germany

    Site Not Available

  • Novartis Investigative Site

    Frankfurt, 60590
    Germany

    Site Not Available

  • Novartis Investigative Site

    Gera, 07548
    Germany

    Site Not Available

  • Novartis Investigative Site

    Halle, 06108
    Germany

    Site Not Available

  • Novartis Investigative Site

    Hamburg, 20354
    Germany

    Site Not Available

  • Novartis Investigative Site

    Hannover, 30625
    Germany

    Site Not Available

  • Novartis Investigative Site

    Heidelberg, 69120
    Germany

    Site Not Available

  • Novartis Investigative Site

    Kassel, 34125
    Germany

    Site Not Available

  • Novartis Investigative Site

    Kiel, 24105
    Germany

    Site Not Available

  • Novartis Investigative Site

    Lubeck, 23538
    Germany

    Site Not Available

  • Novartis Investigative Site

    Ludwigshafen, 67063
    Germany

    Site Not Available

  • Novartis Investigative Site

    Lübeck, 23538
    Germany

    Site Not Available

  • Novartis Investigative Site

    Mainz, 55131
    Germany

    Site Not Available

  • Novartis Investigative Site

    Mannheim, 68167
    Germany

    Site Not Available

  • Novartis Investigative Site

    Muenchen, 81675
    Germany

    Site Not Available

  • Novartis Investigative Site

    Muenster, 48149
    Germany

    Site Not Available

  • Novartis Investigative Site

    München, 81675
    Germany

    Site Not Available

  • Novartis Investigative Site

    Osnabruck, 49074
    Germany

    Site Not Available

  • Novartis Investigative Site

    Osnabrück, 49074
    Germany

    Site Not Available

  • Novartis Investigative Site

    Quedlinburg, 06484
    Germany

    Site Not Available

  • Novartis Investigative Site

    Schwerin, 19055
    Germany

    Site Not Available

  • Novartis Investigative Site

    Selters, 56242
    Germany

    Site Not Available

  • Novartis Investigative Site

    Stade, 21682
    Germany

    Site Not Available

  • Novartis Investigative Site

    Wiesbaden, 65203
    Germany

    Site Not Available

  • Novartis Investigative Site

    Zwickau, 08060
    Germany

    Site Not Available

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