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NCT05947955 · ClinicalTrials.gov registry record · Phase 2
Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)
A Phase 2 study of Acute Respiratory Distress Syndrome and Infections, sponsored by BioAegis Therapeutics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 600
- Enrollment target
- 20
- Study locations
NCT05947955: Recruiting Phase 2 study of Acute Respiratory Distress Syndrome and Infections, sponsored by BioAegis Therapeutics.
NCT05947955 is a Phase 2 study of Acute Respiratory Distress Syndrome and Infections that is actively recruiting participants, run by BioAegis Therapeutics. The registered enrollment target is 600 participants, above the 348-participant average among 31 other Acute Respiratory Distress Syndrome trials with a reported enrollment target (72% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05947955, a Phase 2 study of Acute Respiratory Distress Syndrome and Infections, is actively recruiting participants, sponsored by BioAegis Therapeutics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 600 participants
- Enrollment target
- 20
- Study locations
Study Summary
BTI-203 is a randomized, double-blind, placebo-controlled, multicenter, Phase 2 proof-of-concept (POC) study to evaluate the efficacy and safety of rhu-pGSN plus standard of care (SOC) in subjects with moderate-to-severe ARDS (P/F ratio ≤150) due to pneumonia or other infections. Potential subjects hospitalized with pneumonia or other infections are to be screened within 24 hours of diagnosis of ARDS.
Primary Outcome
Death for any reason through Day 28 between treatment groups
Conditions Studied
Interventions
- DRUG normal saline
- DRUG Rhu-pGSN
Study Locations (20)
Other
- HUB - Hôpital Erasme - Brussels
- CHU Charleroi Marie Curie Hospital - Charleroi
- Centre Hospitalier Regional de la Citadelle - Liège
- Clinique Saint-Pierre Ottignies - Ottignies
- Acibadem City Clinic UMHAT Tokuda - Sofia - Sofia
Pennsylvania
- Penn State Health - Milton S. Hershey Medical Center - Hershey
- Penn State Health - Milton S. Hershey Medical Center - Hershey
- University of Pittsburgh Medical Center - Pittsburgh
California
- University of California Irvine Medical Center - Irvine
- Cedars-Sinai Medical Center - Los Angeles
Kentucky
- University of Louisville Hospital - Jewish Hospital - Louisville
- University of Louisville-Jewish Hospital - Louisville
Texas
- McGovern Medical School - UT Physicians Pulmonary Medicine - Texas Medical Center - Houston
- Baylor Scott & White Health - Temple
Georgia
- Wellstar MCG Augusta University - Augusta
Illinois
- Northwestern University - Pulmonary and Critical Care Medicine - Chicago
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2024-10-03 |
| Est. Completion | 2027-03-01 |
| Phase | Phase 2 |
What NCT05947955 shows while recruiting
NCT05947955 is an interventional study that assigns participants to a tested intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, above the 348-participant average among 31 other Acute Respiratory Distress Syndrome trials with a reported enrollment target (72% higher).
The record links to 2 conditions, with Acute Respiratory Distress Syndrome appearing as the primary indexed condition, and to 2 interventions - of which normal saline is the first listed.
NCT05947955 names 20 study sites across 11 states, led by Other, Pennsylvania, California.
Frequently Asked Questions
What is clinical trial NCT05947955 about?
NCT05947955 is a clinical study titled "Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)". BTI-203 is a randomized, double-blind, placebo-controlled, multicenter, Phase 2 proof-of-concept (POC) study to evaluate the efficacy and safety of rhu-pGSN plus standard of care (SOC) in subjects with moderate-to-severe ARDS (P/F ratio ≤150) due to pneumonia or other infections. Potential subjects ...
What is the current status of trial NCT05947955?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 600 participants. The study started on 2024-10-03. Estimated completion is 2027-03-01.
What conditions does trial NCT05947955 study?
This clinical trial studies the following conditions: Acute Respiratory Distress Syndrome, Infections.
What interventions are being tested in trial NCT05947955?
The interventions under investigation include: normal saline (DRUG), Rhu-pGSN (DRUG).
Who is sponsoring clinical trial NCT05947955?
This trial is sponsored by BioAegis Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05947955 being conducted?
This trial has 20 study locations across California, Georgia, Illinois, Kentucky, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05947955's enrollment target sits among peer trials
600 5th of 31 higher than 26 of 31 other Acute Respiratory Distress Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Respiratory Distress Syndrome 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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