NCT03169894

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

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 or Ulcerative Colitis Who Previously Failed Treatment With an Anti-TNFα Agent

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Avalo Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Crohn Disease
• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	MDGN-002	MDGN-002 is a fully human IgG4 monoclonal antibody specific to human LIGHT.

Timeline

• Start date: 2017-07-14
• Primary completion: 2021-09-14
• Completion: 2021-10-12
• First posted: 2017-05-30
• Last updated: 2024-02-26
• Results posted: 2024-02-26

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study