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Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)

NCT05947955 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2026-01-14

No results posted yet for this 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.

Conditions

Interventions

DRUG

Rhu-pGSN

Intravenous administration based on actual body weight

DRUG

normal saline

intravenous administration in the same volume as the active therapy

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-03
Primary Completion
2026-10-01
Completion
2027-03-01
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Bulgaria
  • Canada
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Netherlands
  • Romania
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05947955 on ClinicalTrials.gov