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NCT03831438 · ClinicalTrials.gov registry record · Phase 1
Safety and Tolerability Study of AVID200 in Pts With Diffuse Cutaneous Systemic Sclerosis
A Phase 1 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT03831438: Completed Phase 1 study, sponsored by Bristol-Myers Squibb.
NCT03831438 is a Phase 1 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03831438, a Phase 1 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
Several lines of evidence place TGF-β, a potent pro-fibrotic cytokine, at the centre of the pathogenesis of Systemic Sclerosis (SSC). AVID200 is a novel inhibitor of TGF-β ligands. This Phase 1 trial is designed to evaluate the safety, tolerability and preliminary efficacy of AVID200 in SSc patients in order delineate doses to be further evaluated in Phase 2. Approximately 9 to 24 male and female patients with documented SSc (i.e., score ≥ 9 according to the American College of Rheumatology/European League Against Rheumatism classification criteria), and classified as having the diffuse cutaneous SSs (dcSSc) subset (i.e., according to the LeRoy and Medsger Classification), will be entered into this Phase 1a, multicentre, open-label, dose-escalation, cohort study of AVID200.
Primary Outcome
Incidence of treatment related adverse events
Interventions
- DRUG AVID200
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2019-01-01 |
| Est. Completion | 2020-06-20 |
| Phase | Phase 1 |
What the finished NCT03831438 record still lists
NCT03831438 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which AVID200 is the first listed.
NCT03831438 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03831438 about?
NCT03831438 is a clinical study titled "Safety and Tolerability Study of AVID200 in Pts With Diffuse Cutaneous Systemic Sclerosis". Several lines of evidence place TGF-β, a potent pro-fibrotic cytokine, at the centre of the pathogenesis of Systemic Sclerosis (SSC). AVID200 is a novel inhibitor of TGF-β ligands. This Phase 1 trial is designed to evaluate the safety, tolerability and preliminary efficacy of AVID200 in SSc patients...
What is the current status of trial NCT03831438?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2019-01-01. Estimated completion is 2020-06-20.
What interventions are being tested in trial NCT03831438?
The interventions under investigation include: AVID200 (DRUG).
Who is sponsoring clinical trial NCT03831438?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03831438's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 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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