A Study to Compare the Efficacy of Guselkumab to Fumaric Acid Esters for the Treatment of Participants With Moderate to Severe Plaque Psoriasis

Last updated: February 27, 2020
Sponsor: Janssen-Cilag G.m.b.H
Overall Status: Completed

Phase

3

Condition

Warts

Rash

Rosacea

Treatment

N/A

Clinical Study ID

NCT02951533
CR108220
2016-002135-15
CNTO1959PSO3008
  • Ages > 18
  • All Genders

Study Summary

The purpose of the study is to compare the efficacy of Guselkumab with commercially available active comparator Fumaderm initial/Fumaderm tablets for the treatment of adult participants with moderate to severe plaque-type psoriasis who have not yet received any systemic therapy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have a diagnosis of plaque-type psoriasis for at least 6 months before the firstadministration of study drug

  • Have a Psoriasis Area and Severity Index (PASI) greater than (>)10 or Body SurfaceArea (BSA) >10 at screening and at baseline

  • Have a Dermatology Life Quality Index (DLQI) >10 at screening and at baseline

  • Agree not to receive a live virus or live bacterial vaccination during the study, orwithin 3 months after the last administration of study drug; for information onBacille Calmette-Guérin (BCG) vaccination, agree not to receive a BCG vaccinationduring the study, or within 12 months after the last administration of study drug

  • No dipstick detection of proteins or glucose in urine. If there are signs of proteinsand/or glucose on urine test strip, the urine sample must be analyzed centrally. Here,protein and glucose levels must not exceed trace levels, example, <=(+); one re-test (central urine analysis) is allowed

Exclusion

Exclusion Criteria:

  • Has a history or current signs or symptoms of severe, progressive, or uncontrolledliver or renal insufficiency, significant cardiac, vascular, pulmonary,gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, ormetabolic disturbances

  • Participants with nonplaque forms of psoriasis (for example, erythrodermic, guttate,or pustular) or with current drug-induced psoriasis (for example, a new onset ofpsoriasis or an exacerbation of psoriasis from beta blockers, calcium channelblockers, or lithium)

  • Known allergies, hypersensitivity, or intolerance to Guselkumab or its excipients

  • Is pregnant, or breast-feeding, or planning to become pregnant while enrolled in thisstudy or within 12 weeks after the last dose of study drug

  • Any condition for which, in the opinion of the investigator, participation would notbe in the best interest of the participant (for example, compromise the well-being) orthat could prevent, limit, or confound the protocol-specified assessments

Study Design

Total Participants: 119
Study Start date:
December 12, 2016
Estimated Completion Date:
February 06, 2019

Connect with a study center

  • Augsburg,
    Germany

    Site Not Available

  • Berlin,
    Germany

    Site Not Available

  • Bielefeld,
    Germany

    Site Not Available

  • Dresden,
    Germany

    Site Not Available

  • Duelmen,
    Germany

    Site Not Available

  • Duesseldorf,
    Germany

    Site Not Available

  • Erlangen,
    Germany

    Site Not Available

  • Essen,
    Germany

    Site Not Available

  • Frankfurt,
    Germany

    Site Not Available

  • Gera,
    Germany

    Site Not Available

  • Hamburg,
    Germany

    Site Not Available

  • Heidelberg,
    Germany

    Site Not Available

  • Jena,
    Germany

    Site Not Available

  • Kiel,
    Germany

    Site Not Available

  • Leipzig,
    Germany

    Site Not Available

  • Luebeck,
    Germany

    Site Not Available

  • Mahlow,
    Germany

    Site Not Available

  • Mainz,
    Germany

    Site Not Available

  • empty

    Marburg,
    Germany

    Site Not Available

  • Memmingen,
    Germany

    Site Not Available

  • Muenchen,
    Germany

    Site Not Available

  • Muenster,
    Germany

    Site Not Available

  • Neu-Ulm,
    Germany

    Site Not Available

  • Osnabrueck,
    Germany

    Site Not Available

  • Selters,
    Germany

    Site Not Available

  • Stuttgart,
    Germany

    Site Not Available

  • Tuebingen,
    Germany

    Site Not Available

  • empty

    Tübingen,
    Germany

    Site Not Available

  • Witten,
    Germany

    Site Not Available

  • empty

    Wuerzburg,
    Germany

    Site Not Available

  • Wuppertal,
    Germany

    Site Not Available

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