Study Phase 3

Multicenter, Randomized, Open-Label, Efficacy Assessor-Blinded, Active Comparator-Controlled Phase 3b Study to Compare the Efficacy of Guselkumab to Fumaric Acid Esters (Fumaderm Initial/ Fumaderm) for Adult Patients With Moderate to Severe Plaque Psoriasis Who Are Candidates for and Naive to Systemic Treatment

Trial Information

Generic NameGuselkumabProduct NameTREMFYA®Therapeutic AreaImmune System DiseasesEnrollment119% Female31.1%% White95.8%
Product ClassmAB anti-IL12 and anti-IL23Sponsor Protocol NumberCNTO1959PSO3008Data PartnerJohnson & JohnsonCondition StudiedPsoriasisMean/Median Age (Years)42.4

Supporting Documentation

  • Collected Datasets Available
  • Data Definition Specification Available
  • Protocol with Amendments Available
  • Statistical Analysis Plan Available
  • Clinical Study Report Available

Approved Data Requests Associated with this Trial

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