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NCT03169894 · ClinicalTrials.gov registry record · Phase 1
Evaluation of the Safety, Tolerability, and Efficacy of MDGN-002 in Adults With Moderate to Severe Active Crohn's Disease or Ulcerative Colitis
A Phase 1 study, sponsored by Avalo Therapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT03169894: Clinical Trial Phase 1 study, sponsored by Avalo Therapeutics.
NCT03169894 is a Phase 1 study that was terminated before completion, run by Avalo Therapeutics. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03169894, a Phase 1 study, was terminated before completion, sponsored by Avalo Therapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study 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.
Primary Outcome
The SES-CD is assessed through endoscopic review of 5 predefined gastrointestinal (GI) segments (ileum; right colon; transverse colon; left colon; rectum). For each segment, 4 endoscopic variables are assessed (presence of ulcers, ulcerated surface, affected surface, and presence of narrowing). Each variable is scored from 0 to 3 with higher scores indicating more severe symptoms. For each variable, the total score is calculated as the sum across all segments of the GI tract. The SES-CD total sc
Interventions
- DRUG MDGN-002
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2017-07-14 |
| Est. Completion | 2021-10-12 |
| Phase | Phase 1 |
Why NCT03169894 stopped before completion
NCT03169894 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which MDGN-002 is the first listed.
NCT03169894 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03169894 about?
NCT03169894 is a clinical study titled "Evaluation of the Safety, Tolerability, and Efficacy of MDGN-002 in Adults With Moderate to Severe Active Crohn's Disease or Ulcerative Colitis". 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-...
What is the current status of trial NCT03169894?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2017-07-14. Estimated completion is 2021-10-12.
What interventions are being tested in trial NCT03169894?
The interventions under investigation include: MDGN-002 (DRUG).
Who is sponsoring clinical trial NCT03169894?
This trial is sponsored by Avalo Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03169894's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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