A World-Wide Clinical Study to Find Out if Intravenous Recombinant Human Plasma Gelsolin Is Safe and Is Beneficial for Treating Acute Respiratory Distress Syndrome (Ards) Caused by Pneumonia or Other Infections

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Bioaegis Therapeutics Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

6 Jan 2025 → ongoing

Decision date (initial)

2024-11-21

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

BARDA (Biomedical Advanced Research and Development Authority, US) · Bioaegis Therapeutics Inc.

External identifiers

EU CT number

2023-510109-16-00

WHO UTN

U1111-1305-2474

ClinicalTrials.gov

NCT05947955

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Safety, Efficacy

To assess the efficacy of IV rhu-pGSN plus SOC vs placebo plus SOC (hereafter referred to as rhu-pGSN vs placebo) administered to subjects with a primary diagnosis of moderate-to-severe ARDS (P/F ratio ≤150) due to pneumonia or other infections

Secondary objectives 2

1. Efficacy: To further assess the efficacy of IV rhu- pGSN vs placebo administered to subjects with a primary diagnosis of moderate-to-severe ARDS (P/F ratio ≤150) due to pneumonia or other infections.
2. Safety: To evaluate the safety of IV rhu-pGSN administered to subjects with a primary diagnosis of moderate-to-severe ARDS due to pneumonia or other infections.

Conditions and MedDRA coding

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

Study design 2 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. 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 saved for review.
2. 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 in any position). 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. 3. Age ≥18 years
4. 4. Informed consent obtained from subject/next of kin/legal proxy
5. 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. 6. During the course of the study starting at screening and for 4 days after the final study treatment, for a total of 10 days: a. Female subjects of childbearing potential must agree to abstinence or use 2 medically accepted and approved birth control methods b. 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 c. All subjects must agree not to donate sperm or eggs

Exclusion criteria 15

1. 1. Ongoing evidence or suspicion that heart failure, volume overload, pulmonary emboli, chronic lung disease, pleural effusion, cardiac tamponade, or constrictive pericarditis are materially contributing to the clinical or radiological findings as 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. 10. Known allergy to study drug or excipients
3. 11. Weight >125 kg or <32 kg
4. 12. 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.
5. 13. Transplantation of hematopoietic or solid organs, graft versus host disease, or post-transplant lymphoproliferative disease.
6. 2. Systemic fungal, yeast, or parasitic, or mycobacterial infection
7. 3. Current or planned receipt of extracorporeal membrane oxygenation (ECMO).
8. 4. Pregnant or lactating women.
9. 5. Permanent tracheostomy or chronic ventilatory support
10. 6. Previous splenectomy
11. 7. Immunosuppressed condition
12. 8. Any vaccination in the previous 30 days
13. 9. Participation in an interventional clinical trial (e.g., device, drug, or biologic) in the previous 30 days or 5 half-lives of the previous medicinal product, if longer
14. 14. Chronic mechanical ventilation or dialysis
15. 15. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. All-cause mortality at Day 28 between treatment groups

Secondary endpoints 11

1. Efficacy: Ventilator-free days through Day 28 between treatment groups
2. Efficacy: All-cause mortality at Day 60 between treatment groups
3. Efficacy: Proportion of surviving subjects without respiratory support at Day 28 between treatment groups
4. Efficacy: Time to death and proportions of subjects dying over time (Days 7, 14, and 28) between treatment groups
5. Efficacy: Proportion of surviving subjects without respiratory support over time (Days 7, 14, and 28) between treatment groups
6. Efficacy: Time to discontinuation of respiratory support and proportions without respiratory support over time (Days 7, 14, and 28) between treatment groups
7. Efficacy: For subjects not intubated at entry, the frequency of intubation through Day 28 between treatment groups
8. Efficacy: To evaluate the days in the ICU and in the hospital through Day 28 between treatment groups
9. Efficacy: Frequency of RRT through Day 28 between treatment groups
10. 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
11. Safety: New or worsening clinically significant laboratory abnormalities in rhu-pGSN vs placebo groups

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bioaegis Therapeutics Inc.

Sponsor organisation

Bioaegis Therapeutics Inc.

Address

6 East Cove Lane

City

Morristown

Postcode

07960-2700

Country

United States

Scientific contact point

Organisation

Bioaegis Therapeutics Inc.

Contact name

Susan Levinson

Public contact point

Organisation

Bioaegis Therapeutics Inc.

Contact name

Susan Levinson

Third parties 5

Locations

10 EU/EEA countries · 54 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 141 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

15 submissions — initial application plus substantial / non-substantial modifications