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])
Phase of Trial: Phase I
Latest Information Update: 24 Dec 2018
At a glance
- Drugs AEVI 002 (Primary)
- Indications Crohn's disease
- Focus Adverse reactions
- Sponsors Aevi Genomic Medicine
- 06 Nov 2018 Planned End Date changed from 1 Nov 2018 to 1 Jul 2019.
- 06 Nov 2018 Planned primary completion date changed from 1 Oct 2018 to 1 Jun 2019.
- 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.