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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 is a Phase 1 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 9 participants.
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.
Interventions
- DRUG AVID200
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2019-01-01 |
| Est. Completion | 2020-06-20 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03831438
The ClinicalTrials.gov registry entry for NCT03831438 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which AVID200 is the first listed.
NCT03831438 reports 0 study locations.
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.
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