Phase Ib Escalating Dose, Open-Label, Signal-Finding Study to Evaluate the Safety, Tolerability, and Short-Term Efficacy of the Anti-Light Monoclonal Antibody MDGN-002 in Adults With Moderate to Severe Active Crohn's Disease Who Previously Failed Treatment With an Anti-TNFα Agent, With and Without Loss of Function Mutations in Decoy Receptor 3 (Anti-LIGHT in Anti-TNFα-Resistant Crohn's Disease [TRaCk LIGHT])

Trial Profile

Phase Ib Escalating Dose, Open-Label, Signal-Finding Study to Evaluate the Safety, Tolerability, and Short-Term Efficacy of the Anti-Light Monoclonal Antibody MDGN-002 in Adults With Moderate to Severe Active Crohn's Disease Who Previously Failed Treatment With an Anti-TNFα Agent, With and Without Loss of Function Mutations in Decoy Receptor 3 (Anti-LIGHT in Anti-TNFα-Resistant Crohn's Disease [TRaCk LIGHT])

Recruiting
Phase of Trial: Phase I

Latest Information Update: 02 Aug 2018

At a glance

  • Drugs AEVI 002 (Primary)
  • Indications Crohn's disease
  • Focus Adverse reactions
  • Sponsors Aevi Genomic Medicine
  • Most Recent Events

    • 02 Aug 2018 According to the Aevi Genomic Medicine media release, the Company has not yet enrolled any patients into this trial. To address the continued enrolment challenges for this program, the Company is evaluating the addition of clinical trial sites outside the United States.
    • 15 May 2018 According to the Aevi Genomic Medicine media release, the company has completed the addition of three new clinical sites and patient screening is underway. Data from the study are expected by year-end 2018.
    • 25 Sep 2017 Planned End Date changed from 1 Aug 2018 to 1 Nov 2018.
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