drugset / Trial / NCT03169894

Evaluation of the Safety, Tolerability, and Efficacy of MDGN-002 in Adults With Moderate to Severe Active Crohn's Disease or Ulcerative Colitis

NCT03169894 ↗

Phase 1 Terminated 8 enrolled Avalo Therapeutics, Inc.
NaSingle-groupOpen-labelTreatment

Summary

This is a Phase 1b, open-label, dose-escalation, signal-finding, multi-center study. The study will evaluate the safety, tolerability, pharmacokinetics and short-term efficacy of MDGN-002 in adults with moderate to severe, active Crohn's disease or Ulcerative Colitis who have previously failed anti-tumor necrosis factor alpha (anti-TNFα) treatment.

Timeline

Start
2017-07-14
Primary completion
2021-09-14
Completion
2021-10-12

Outcome

Outcome not reported

Stopped (Business): “Strategic reasons”

Drugs

EvaluationDrugModalityDoseRoute
Subject QUISOVALIMAB Monoclonal antibody 1 mg/kg Subcutaneous
Subject QUISOVALIMAB Monoclonal antibody 3 mg/kg Subcutaneous