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


Clinical study data provided through this site do not replace the official labeling of a given drug product, which presents benefits and risks of the product for approved use(s). Before prescribing any product, health care professionals should consult the current prescribing information approved in their country. Patients seeking information may consult with their health care professional about the product, for which health authority approved written patient information may be available.