A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLEBLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY, FOLLOWED BY AN ACTIVE-TREATMENT PHASE TO EVALUATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) IN THE TREATMENT OF SUBJECTS WITH ACTIVE BEHCET'S DISEASE

Trial Profile

A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLEBLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY, FOLLOWED BY AN ACTIVE-TREATMENT PHASE TO EVALUATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) IN THE TREATMENT OF SUBJECTS WITH ACTIVE BEHCET'S DISEASE

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 28 Apr 2018

At a glance

  • Drugs Apremilast (Primary)
  • Indications Behcet's syndrome
  • Focus Registrational; Therapeutic Use
  • Acronyms RELIEF
  • Sponsors Celgene Corporation
  • Most Recent Events

    • 17 Feb 2018 According to the Celgene Corporation media release, company plans to submit supplemental New Drug Applications for apremilast 30 mg BID for the treatment of active Behcet's Disease with oral ulcers in the U.S. and Japan in the second half of this year and a Type II Variation to the Marketing Authorization Application in the EU in 2019, on the basis of data from this study.
    • 17 Feb 2018 According to the Celgene Corporation media release, date from this trial were presented in a late-breaking oral presentation at the 2018 American Academy of Dermatology (AAD) Annual Meeting.
    • 17 Feb 2018 Results published in the Celgene Corporation media release.
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