Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)

Part of paid clinical trials in Irvine, California.

Sponsor
BioAegis Therapeutics Inc.
Study ID
NCT05947955
Phase
PHASE2
Status
Recruiting
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Conditions

  • Acute Respiratory Distress Syndrome
  • Infections

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rhu-pGSN — DRUG
    Intravenous administration based on actual body weight
  • normal saline — DRUG
    intravenous administration in the same volume as the active therapy

Study Details

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.

Key Dates

Start date
Oct 3, 2024
Status verified
Jan 2026
Primary completion
Oct 1, 2026
Completion
Mar 1, 2027

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rhu-pGSN Treatment
    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 .
  • Placebo Comparator: Normal Saline Placebo
    Subjects will receive 6 doses of normal-saline placebo in volumes equivalent to subjects given rhu-pGSN in addition to standard care.

Primary Outcome Measure

All-cause mortality at day 28 [ Time Frame: 28 days ]

Central Contacts

Locations (15)

FacilityCityStateZIPSite coordinators
University of California Irvine Medical CenterIrvineCalifornia92868
Rosie Magallon
[email protected]
714-509-6082
Alpesh Amin, MD (PRINCIPAL_INVESTIGATOR)
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
Vivian Hwe
[email protected]
424-314-0585
Yuri Matusov, MD (PRINCIPAL_INVESTIGATOR)
Wellstar MCG Augusta UniversityAugustaGeorgia30912
Marti Farrough, RN
[email protected]
706-723-0106
Shaheen Islam, MD (PRINCIPAL_INVESTIGATOR)
Northwestern University - Pulmonary and Critical Care MedicineChicagoIllinois60611
Helen K Donnelly, MS, BSN, RN, CCRC
Helen K Donnelly <[email protected]>
312-503-1097
Richard G Wunderink, MD (PRINCIPAL_INVESTIGATOR)
University of Louisville Hospital - Jewish HospitalLouisvilleKentucky40202
Julie Burmester
[email protected]
502-852-2601
Mohamed Saad, MD (PRINCIPAL_INVESTIGATOR)
University of Louisville-Jewish HospitalLouisvilleKentucky40202
Julie Burmester
[email protected]
502-852-2601
Mohamed Saad, MD (PRINCIPAL_INVESTIGATOR)
Mayo ClinicRochesterMinnesota55905
Amy Schuchard
[email protected]
507-293-7023
Yewande Odeyemi, M.B.B.S. (PRINCIPAL_INVESTIGATOR)
Hannibal Regional HospitalHannibalMissouri63401
Lindsey Gander, RN CRC
[email protected]
573-629-3926
Humam Farah, MD (PRINCIPAL_INVESTIGATOR)
Bryan Medical CenterLincolnNebraska68506
Amber Retzlaff, RN, BSN
[email protected]
402-481-8119
Radu Neamu, MD (PRINCIPAL_INVESTIGATOR)
New York University Grossman School of MedicineNew YorkNew York10016
Natalia Leontovich
[email protected]
917-227-0932
Sam Parnia, MD (PRINCIPAL_INVESTIGATOR)
Penn State Health - Milton S. Hershey Medical CenterHersheyPennsylvania17033
Kylee Kimbel
[email protected]
Lauren J Van Scoy, MD (PRINCIPAL_INVESTIGATOR)
Penn State Health - Milton S. Hershey Medical CenterHersheyPennsylvania17033
Kylee Kimbel
[email protected]
(717) 802-7508
Lauren Van Scoy, MD (PRINCIPAL_INVESTIGATOR)
University of Pittsburgh Medical CenterPittsburghPennsylvania15261
Chelsea Peet
[email protected]
Bryan McVerry, MD (PRINCIPAL_INVESTIGATOR)
McGovern Medical School - UT Physicians Pulmonary Medicine - Texas Medical CenterHoustonTexas77030
Elizabeth Vidales
[email protected]
713-486-6154
Bela Patel, MD (PRINCIPAL_INVESTIGATOR)
Baylor Scott & White HealthTempleTexas76508
Michelle Trevino
[email protected]
254-724-7261
Alfredo Vazquez Sandoval, MD (PRINCIPAL_INVESTIGATOR)

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