JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort A: Vilobelimab

PHASE2RecruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

June 21, 2025

Primary Completion Date

November 26, 2027

Study Completion Date

February 8, 2028

Conditions
Acute Respiratory Distress Syndrome (ARDS)ARDSARDS (Acute Respiratory Distress Syndrome)Acute Respiratory Distress Syndrome
Interventions
DRUG

Cohort A: vilobelimab

Administered as an IV formulation of 800 mg per dose and up to 6 doses (planned for Days 1, 2, 4, 8, 15, and 22, if participant is in hospital setting and deemed appropriate by the investigator)

DRUG

Cohort A: placebo

Administered as an IV formulation of placebo of up to 6 doses (planned for Days 1, 2, 4, 8, 15, and 22, if participant is in hospital setting and deemed appropriate by the investigator)

Trial Locations (16)

10467

RECRUITING

Montefiore Hospital - Moses Campus, The Bronx

90806-1701

RECRUITING

Long Beach Memorial Medical Center, Long Beach

92868-3201

RECRUITING

University of California Irvine Medical Center, Orange

20010-3017

RECRUITING

MedStar Washington Hospital Center, Washington D.C.

34209-4617

RECRUITING

Nova Clinical Research, Bradenton

83712-6241

RECRUITING

St. Luke's Boise Medical Center, Boise

61637-0001

RECRUITING

OSF Saint Francis Medical Center-, Peoria

01805-0001

RECRUITING

Lahey Hospital and Medical Center, Burlington

55905-0001

RECRUITING

Mayo Clinic, Rochester

89502-1576

WITHDRAWN

Renown Institute for Heart & Vascular Health, Reno

08901-1928

RECRUITING

Robert Wood Johnson Medical School, New Brunswick

27599-0001

RECRUITING

University of North Carolina at Chapel Hill, Chapel Hill

27705-3875

RECRUITING

Durham VA Medical Center, Durham

43608-2603

RECRUITING

Mercy Health - St. Vincent Medical Center, Toledo

73104-3609

RECRUITING

The University of Oklahoma Health Sciences Center, Oklahoma City

97239-3011

RECRUITING

Oregon Health and Science University, Portland

All Listed Sponsors
collaborator

Biomedical Advanced Research and Development Authority

FED

collaborator

InflaRx GmbH

INDUSTRY

collaborator

Edesa Biotech Inc.

INDUSTRY

collaborator

Genentech, Inc.

INDUSTRY

lead

PPD Development, LP

INDUSTRY