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A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy And Safety Of Adjunctive Recombinant Human Plasma Gelsolin With Standard of Care for Moderate-to-Severe ARDS Due to Pneumonia or Other Infections

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-510109-16-00
Acronym
BTI-203
Enrollment
372
Registered
2024-11-18
Start date
2025-01-06
Completion date
Unknown
Last updated
2026-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome (ARDS) Due to Pneumonia or other Infections

Brief summary

All-cause mortality at Day 28 between treatment groups

Detailed description

Efficacy: Ventilator-free days through Day 28 between treatment groups, Efficacy: All-cause mortality at Day 60 between treatment groups, Efficacy: Proportion of surviving subjects without respiratory support at Day 28 between treatment groups, Efficacy: Time to death and proportions of subjects dying over time (Days 7, 14, and 28) between treatment groups, Efficacy: Proportion of surviving subjects without respiratory support over time (Days 7, 14, and 28) between treatment groups, Efficacy: Time to discontinuation of respiratory support and proportions without respiratory support over time (Days 7, 14, and 28) between treatment groups, Efficacy: For subjects not intubated at entry, the frequency of intubation through Day 28 between treatment groups, Efficacy: To evaluate the days in the ICU and in the hospital through Day 28 between treatment groups, Efficacy: Frequency of RRT through Day 28 between treatment groups, Safety: Incidence, causality, and severity of SAEs and AEs (graded according to the NCI CTCAE version 5.0 [or higher]) in rhu-pGSN vs placebo groups, Safety: New or worsening clinically significant laboratory abnormalities in rhu-pGSN vs placebo groups

Interventions

Sponsors

Bioaegis Therapeutics Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
All-cause mortality at Day 28 between treatment groups

Secondary

MeasureTime frame
Efficacy: Ventilator-free days through Day 28 between treatment groups, Efficacy: All-cause mortality at Day 60 between treatment groups, Efficacy: Proportion of surviving subjects without respiratory support at Day 28 between treatment groups, Efficacy: Time to death and proportions of subjects dying over time (Days 7, 14, and 28) between treatment groups, Efficacy: Proportion of surviving subjects without respiratory support over time (Days 7, 14, and 28) between treatment groups, Efficacy: Time to discontinuation of respiratory support and proportions without respiratory support over time (Days 7, 14, and 28) between treatment groups, Efficacy: For subjects not intubated at entry, the frequency of intubation through Day 28 between treatment groups, Efficacy: To evaluate the days in the ICU and in the hospital through Day 28 between treatment groups, Efficacy: Frequency of RRT through Day 28 between treatment groups, Safety: Incidence, causality, and severity of SAEs and AEs (graded

Countries

Belgium, Bulgaria, Czechia, France, Germany, Hungary, Italy, Netherlands, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026