Clinical Trial: Study of IFN-K in Dermatomyositis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase IIa, Single Blind, Randomized, Study to Evaluate the Safety, the Immunogenicity, and the Clinical and Biological Efficacy of IFNα-Kinoid (IFN-K) in Adult Subjects With Same as current

Current Secondary Outcome:

  • Number of subjects with treatment related adverse events [ Time Frame: Week 48 ]
  • Response to treatment with IFN-K as measured by MMT5/MMT8 [ Time Frame: Week 48 ]
  • Response to treatment with IFN-K as measured by CDASI [ Time Frame: Week 48 ]
  • Response to treatment with IFN-K as measured by Physician global activity (PGA) [ Time Frame: Week 48 ]
  • Response to treatment with IFN-K as measured by Patient Global Activity [ Time Frame: Week 48 ]
  • Response to treatment with IFN-K as measured by Health Assessment Questionnaire (HAQ),Dermatology Life Quality Index (DLQI) [ Time Frame: Week 48 ]
  • Immune response induced by IFN-K as measured by antibodies production [ Time Frame: Week 48 ]


Original Secondary Outcome: Same as current

Information By: Neovacs

Dates:
Date Received: November 25, 2016
Date Started: November 2016
Date Completion:
Last Updated: November 29, 2016
Last Verified: November 2016