Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)

NCT05947955 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: BTI-203
• Study Type: interventional
• Target: 600
• Locations: 13 countries
• Sites: 76

Brief 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

Acute Respiratory Distress Syndrome; Infections

Keywords

moderate to severe ARDS; respiratory failure; rhu-pGSN

Outcome Measures

Primary Outcomes (1)

• All-cause mortality at day 28

  Death for any reason through Day 28 between treatment groups

  28 days

Secondary Outcomes (9)

• Ventilator-free days

  28 days

• All-cause mortality at day 60

  60 days

• Proportion of surviving subjects without respiratory support

  28 days

• Time to death and proportions of subjects dying over time

  28 days

• Time to discontinuation of respiratory support and proportions without respiratory support

  28 days

Study Arms (2)

Rhu-pGSN Treatment

EXPERIMENTAL

Subjects will receive rhu-pGSN 24 mg/kg once, followed by 5 daily doses of 12 mg/kg based on actual body weight in addition to standard care .

Drug: Rhu-pGSN

Normal Saline Placebo

PLACEBO COMPARATOR

Subjects will receive 6 doses of normal-saline placebo in volumes equivalent to subjects given rhu-pGSN in addition to standard care.

Drug: normal saline

Interventions

Rhu-pGSN DRUG

Intravenous administration based on actual body weight

Also known as: recombinant human gelsolin

Rhu-pGSN Treatment

normal saline DRUG

intravenous administration in the same volume as the active therapy

Also known as: 0.9% sterile saline

Normal Saline Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.
• Age ≥18 years
• Informed consent obtained from subject/next of kin/legal proxy
• 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
• During the course of the study starting at screening and for at least 3 months after their final study treatment:
• Female subjects of childbearing potential must agree to use 2 medically accepted and approved birth control methods
• 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
• All subjects must agree not to donate sperm or eggs

You may not qualify if:

• 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.
• Presence of systemic fungal, yeast, parasitic, or mycobacterial infection
• Current or planned receipt of extracorporeal membrane oxygenation (ECMO)
• Pregnant or lactating women
• Previous splenectomy
• Any vaccination in the previous 30 days
• Participation in an investigational clinical trial (e.g., device, drug, or biologic) in the previous 30 days
• Known allergy to study drug or excipients
• Weight \>125 kg
• 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
• Transplantation of hematopoietic or solid organs, graft versus host disease, or post-transplant lymphoproliferative disease
• Chronic mechanical ventilation or dialysis
• 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.

Sponsors & Collaborators

• BioAegis Therapeutics Inc.: lead
• Biomedical Advanced Research and Development Authority: collaborator

Study Sites (76)

University of California Irvine Medical Center

Irvine, California, 92868, United States

RECRUITING

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Wellstar MCG Augusta University

Augusta, Georgia, 30912, United States

RECRUITING

Northwestern University - Pulmonary and Critical Care Medicine

Chicago, Illinois, 60611, United States

RECRUITING

University of Louisville Hospital - Jewish Hospital

Louisville, Kentucky, 40202, United States

RECRUITING

University of Louisville-Jewish Hospital

Louisville, Kentucky, 40202, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Hannibal Regional Hospital

Hannibal, Missouri, 63401, United States

RECRUITING

Bryan Medical Center

Lincoln, Nebraska, 68506, United States

RECRUITING

New York University Grossman School of Medicine

New York, New York, 10016, United States

NOT YET RECRUITING

Penn State Health - Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

RECRUITING

Penn State Health - Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15261, United States

RECRUITING

McGovern Medical School - UT Physicians Pulmonary Medicine - Texas Medical Center

Houston, Texas, 77030, United States

RECRUITING

Baylor Scott & White Health

Temple, Texas, 76508, United States

RECRUITING

HUB - Hôpital Erasme

Brussels, 1070, Belgium

RECRUITING

CHU Charleroi Marie Curie Hospital

Charleroi, 6042, Belgium

RECRUITING

Centre Hospitalier Regional de la Citadelle

Liège, 4000, Belgium

RECRUITING

Clinique Saint-Pierre Ottignies

Ottignies, 1340, Belgium

RECRUITING

Acibadem City Clinic UMHAT Tokuda - Sofia

Sofia, 1407, Bulgaria

RECRUITING

Military Medical Academy

Sofia, 1606, Bulgaria

RECRUITING

UMHAT "Alexandrovska" EAD

Sofia, Bulgaria

RECRUITING

Foothills Medical Centre

Calgary, Alberta, AB T2N 5A1, Canada

RECRUITING

Royal Alexandra Hospital

Edmonton, Alberta, T5H3V9, Canada

RECRUITING

Grey Nuns Hospital

Edmonton, Alberta, T6L 5X8, Canada

RECRUITING

Lions Gate Hospital

North Vancouver, British Columbia, V7L 2L7, Canada

RECRUITING

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

University Health Network (UHN)-Toronto General Hospital (TGH)

Toronto, Ontario, M5G 2N2, Canada

RECRUITING

McGill University Health Centre - Royal Victoria Hospital (MUHC-RVH)

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

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, H4J1C5, Canada

RECRUITING

Peter Lougheed Centre

Calgary, T1Y 6J4, Canada

RECRUITING

Rocky View General Hospital

Calgary, T2V 1P9, Canada

RECRUITING

South Health Campus

Calgary, T3M 1M4, Canada

RECRUITING

St. Anne's University Hospital

Brno, 602 00, Czechia

RECRUITING

University Hospital Královské Vinohrady

Prague, 100 34 10, Czechia

RECRUITING

General University Hospital

Prague, 2, 12000, Czechia

RECRUITING

Centre Hospitalier Departemental (CHD) Vendee

La Roche-sur-Yon, France

RECRUITING

Hôpital du Kremlin Bicêtre, APHP

Le Kremlin-Bicêtre, 94275, France

RECRUITING

Centre Hospitalier de Melun-Senart

Melun, 77000, France

RECRUITING

CHU Nantes

Nantes, 1, France

RECRUITING

Centre Hospitalier Lyon Sud

Oullins-Pierre-Bénite, 69495, France

RECRUITING

Hopital Pitie-Salpetriere

Paris, 75013, France

RECRUITING

Tenon Hospital

Paris, 75020, France

RECRUITING

Nouvel Hopital Civil

Strasbourg, 67091, France

NOT YET RECRUITING

Saarland University Hospital

Homburg, 66421, Germany

RECRUITING

Jena University Hospital

Jena, 07747, Germany

RECRUITING

University Hospital LMU Munich

Munich, D-81377, Germany

RECRUITING

National Institute of Pulmonology

Budapest, H-1121, Hungary

RECRUITING

Petz Aladár University Teaching Hospital

Győr, H-9023, Hungary

RECRUITING

Szent Damján Greek Catholic Hospital

Kisvárda, 4600, Hungary

RECRUITING

Szabolcs-Szatmar-Bereg County Teaching Hospital, Andras Josa Hospital

Nyíregyháza, H-4400, Hungary

RECRUITING

Hospital of Siofok

Siófok, 8600, Hungary

RECRUITING

Teaching Hospital of Vas County

Szombathely, Hungary

RECRUITING

Ferenc Csolnoky Hospital of Veszprem County

Veszprém, H-8200, Hungary

RECRUITING

Asst-Spedali Civili di Brescia

Brescia, 25123, Italy

RECRUITING

Fondazione Policlinico A. Gemelli IRCCS

Rome, 00165, Italy

RECRUITING

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, Netherlands

RECRUITING

Gelre Hospitals, Department of ICU

Apeldoorn, Netherlands

RECRUITING

Gelderse Vallei Hospital

Ede, Netherlands

RECRUITING

Medisch Spectrum Twente

Enschede, 7512 KZ, Netherlands

RECRUITING

Canisius Wilhelmina Ziekenhuis

Nijmegen, 6532 SZ, Netherlands

RECRUITING

University Hospital of Bucharest

Bucharest, 050098, Romania

RECRUITING

Spital Universitar de Urgenta ELIAS (University Emergency Hospital Elias)

Bucharest, Romania

RECRUITING

County Clinical Hospital Tirgu Mures

Târgu Mureş, 540103, Romania

RECRUITING

Clinical County Hospital Timisoara

Timișoara, 300723, Romania

RECRUITING

Hospital Clínic Barcelona

Barcelona, 08030, Spain

RECRUITING

University Hospital of Bucharest

Barcelona, 08208, Spain

RECRUITING

Bellvitge University Hospital

Barcelona, 08907, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Hospital Universitario de Getafe

Madrid, 28905, Spain

RECRUITING

Clínico San Carlos

Madrid, Spain

RECRUITING

Hospital Universitari de Tarragona Joan XXIII

Tarragona, 43005, Spain

RECRUITING

Hospital Universitari Sant Joan de Reus

Tarragona, 43204, Spain

RECRUITING

University Hospital of Wales

Cardiff, CF14 4XW, United Kingdom

RECRUITING

Derriford Hospital (University Hospitals Plymouth Hospital Trust)

Plymouth, PL6 8DH, United Kingdom

RECRUITING

Pinderfields Hospital (Mid Yorkshire Teaching NHS Trust)

Wakefield, WF1 4DG, United Kingdom

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome; Infections; Respiratory Insufficiency

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Howard Levy, MD PhD

CONTACT

848-992-5888; hlevy@hlevyconsulting.com

Dmytro Pomishchyk

CONTACT

502-648-2138; dmytro.pomishchyk@ergomedgroup.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The placebo of normal saline is visibly indistinguishable from the study drug ans is to be at the same volume of administration.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 1:1 randomization to rhu-pGSN or saline placebo arm

Study Record Dates

• First Submitted: July 9, 2023
• First Posted: July 17, 2023
• Study Start: October 3, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

CZ (3); ES (8); GB (3); BU (3); BE (4); NL (5); IT (2); RO (4); DE (3); CA (11); US (15); FR (8); HU (7)