RECRUITING Phase 2 ClinicalTrials.gov

Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)

Sponsor: BioAegis Therapeutics Inc. • ClinicalTrials.gov ID: NCT05947955

Registry updated: 2026-10-20

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Description

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.

Interventions

Rhu-pGSN (Drug)
Intravenous administration based on actual body weight
normal saline (Drug)
intravenous administration in the same volume as the active therapy

Eligibility criteria

Inclusion Criteria: 1. Infection followed within a week of documented bilateral infiltrates/opacities consistent with ARDS, as assessed by the admitting emergency department, clinic, intensivist, or ward physician or equivalent caregiver or a radiologist * Investigator or designee to note radiologic findings in the electronic case report form (eCRF) * Radiology report and conclusion should be summarized in the eCRF * A digital copy of the radiograph uploaded and saved for review 2. Acute hypoxemic respiratory failure (moderate-to-severe ARDS) for ≤48 hours associated with suspected or confirmed infection (moderate-to-severe ARDS defined by the ratio of arterial pressure of O2 to the fraction of inspired O2 ≤150). Eligible subjects will be intubated for mechanical ventilation, receiving noninvasive ventilation by continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP), or on HFNO at least 30 L/min of 50% or greater inspired O2. Although it is expected that most eligible subjects will be receiving positive end-expiratory pressure (PEEP) or CPAP ≥5 cm H2O consistent with the original Berlin definition (ARDS Definition Task Force 2012), these measures will not be mandated as entry criteria. 3. Age ≥18 years 4. Informed consent obtained from subject/next of kin/legal proxy 5. Clear or convincing evidence of a precipitating infection during the 7 days preceding the diagnosis of ARDS in the judgement of the screening or primary care team 6. During the course of the study starting at screening and for at least 3 months after their final study treatment: 1. Female subjects of childbearing potential must agree to use 2 medically accepted and approved birth control methods 2. Male subjects with a partner who might become pregnant must agree to use reliable forms of contraception (i.e., vasectomy, abstinence), or an acceptable method of birth control must be used by the partner 3. All subjects must agree not to donate sperm or eggs Exclusion Criteria: 1. Ongoing evidence or suspicion that heart failure, volume overload, pulmonary emboli, atelectasis, chronic lung disease, pleural effusion, cardiac tamponade, or constrictive pericarditis are materially contributing to the clinical or radiological findings bas assessed by the care team or Investigator; an echocardiogram is strongly recommended as part of standard care to exclude a significant contribution of systolic or diastolic heart failure and volume overload. 2. Presence of systemic fungal, yeast, parasitic, or mycobacterial infection 3. Current or planned receipt of extracorporeal membrane oxygenation (ECMO) 4. Pregnant or lactating women 5. Previous splenectomy 6. Any vaccination in the previous 30 days 7. Participation in an investigational clinical trial (e.g., device, drug, or biologic) in the previous 30 days 8. Known allergy to study drug or excipients 9. Weight \>125 kg 10. Active underlying cancer or treatment with systemic chemotherapy or radiation therapy during the last 60 days or likely to require similar treatments during the ensuing 6 months 11. Transplantation of hematopoietic or solid organs, graft versus host disease, or post-transplant lymphoproliferative disease 12. Chronic mechanical ventilation or dialysis 13. Unsuitable for study participation, in the opinion of the Investigator, because of chronic, severe, end-stage, or life-limiting underlying disease unrelated to current infection likely to interfere with management and assessment of ARDS, only comfort or limited (non-aggressive) care is to be given, or life expectancy \<6 months unrelated to acute infection in the opinion of the Investigator.

Conditions

Acute Respiratory Distress Syndrome Infections

Locations

Cedars-Sinai Medical Center — Los Angeles, California, United States
Wellstar MCG Augusta University — Augusta, Georgia, United States
Northwestern University - Pulmonary and Critical Care Medicine — Chicago, Illinois, United States
University of Louisville Hospital - Jewish Hospital — Louisville, Kentucky, United States
University of Louisville-Jewish Hospital — Louisville, Kentucky, United States
Mayo Clinic — Rochester, Minnesota, United States
Hannibal Regional Hospital — Hannibal, Missouri, United States
New York University Grossman School of Medicine — New York, New York, United States
Penn State Health - Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
McGovern Medical School - UT Physicians Pulmonary Medicine - Texas Medical Center — Houston, Texas, United States
HUB - Hôpital Erasme — Brussels, Belgium
CHU Charleroi Marie Curie Hospital — Charleroi, Belgium
Centre Hospitalier Regional de la Citadelle — Liège, Belgium
Clinique Saint-Pierre Ottignies — Ottignies, Belgium
UMHAT "Alexandrovska" EAD — Sofia, Bulgaria
Foothills Medical Centre — Calgary, Alberta, Canada
Grey Nuns Hospital — Edmonton, Alberta, Canada
Lions Gate Hospital — North Vancouver, British Columbia, Canada
Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada
University Health Network (UHN)-Toronto General Hospital (TGH) — Toronto, Ontario, Canada
McGill University Health Centre - Royal Victoria Hospital (MUHC-RVH) — Montreal, Quebec, Canada
Centre intégré universitaire de santé et services sociaux du nord de l'île de Montréal-Hôpital du Sacré de Montréal (CIUSSS-NÎM-HSCM) — Montreal, Quebec, Canada
Peter Lougheed Centre — Calgary, Canada
Rocky View General Hospital — Calgary, Canada
South Health Campus — Calgary, Canada
St. Anne's University Hospital — Brno, Czechia
University Hospital Královské Vinohrady — Prague, Czechia
General University Hospital — Prague, Czechia
Centre Hospitalier Departemental (CHD) Vendee — La Roche-sur-Yon, France
Hôpital du Kremlin Bicêtre, APHP — Le Kremlin-Bicêtre, France
Centre Hospitalier de Melun-Senart — Melun, France
CHU Nantes — Nantes, France
Centre Hospitalier Lyon Sud — Oullins-Pierre-Bénite, France
Hopital Pitie-Salpetriere — Paris, France
Tenon Hospital — Paris, France
Nouvel Hopital Civil — Strasbourg, France
Saarland University Hospital — Homburg, Germany
Jena University Hospital — Jena, Germany
University Hospital LMU Munich — Munich, Germany
National Institute of Pulmonology — Budapest, Hungary
Szent Damján Greek Catholic Hospital — Kisvárda, Hungary
Szabolcs-Szatmar-Bereg County Teaching Hospital, Andras Josa Hospital — Nyíregyháza, Hungary
Hospital of Siofok — Siófok, Hungary
Ferenc Csolnoky Hospital of Veszprem County — Veszprém, Hungary
Asst-Spedali Civili di Brescia — Brescia, Italy
Fondazione Policlinico A. Gemelli IRCCS — Rome, Italy
Jeroen Bosch Ziekenhuis — 's-Hertogenbosch, Netherlands
Gelre Hospitals, Department of ICU — Apeldoorn, Netherlands
Gelderse Vallei Hospital — Ede, Netherlands
Medisch Spectrum Twente — Enschede, Netherlands
Canisius Wilhelmina Ziekenhuis — Nijmegen, Netherlands
University Hospital of Bucharest — Bucharest, Romania
County Clinical Hospital Tirgu Mures — Târgu Mureş, Romania
Clinical County Hospital Timisoara — Timișoara, Romania
Hospital Clínic Barcelona — Barcelona, Spain
University Hospital of Bucharest — Barcelona, Spain
Bellvitge University Hospital — Barcelona, Spain
Hospital Universitario 12 de Octubre — Madrid, Spain
Hospital Universitario de Getafe — Madrid, Spain
Clínico San Carlos — Madrid, Spain
Hospital Universitari Sant Joan de Reus — Tarragona, Spain
University Hospital of Wales — Cardiff, United Kingdom
Derriford Hospital (University Hospitals Plymouth Hospital Trust) — Plymouth, United Kingdom
Pinderfields Hospital (Mid Yorkshire Teaching NHS Trust) — Wakefield, United Kingdom

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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