JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort A: Vilobelimab
Phase 2 Clinical Platform Trial Investigating Multiple Therapeutic Options for the Treatment of Hospitalized Patients With Acute Respiratory Distress Syndrome (ARDS)
2 other identifiers
interventional
200
1 country
36
Brief Summary
This is a Phase 2 multicenter, randomized, double-blinded, placebo-controlled study that will evaluate the safety and efficacy of host-directed therapeutics in hospitalized adults diagnosed with Acute Respiratory Distress Syndrome (ARDS) utilizing a platform trial design. Cohort A: Participants will be randomized to receive either a placebo or vilobelimab. This record describes the default procedures and analyses for Cohort A. Please see NCT06703073 for information on the BP-ARDS-P2-001 Master Protocol.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2025
Typical duration for phase_2
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2024
CompletedFirst Posted
Study publicly available on registry
November 22, 2024
CompletedStudy Start
First participant enrolled
June 21, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2028
March 25, 2026
February 1, 2026
3 years
November 20, 2024
March 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
All-cause mortality (ACM) rate at Day 28
Day 28
Secondary Outcomes (19)
ACM at Day 60 and Day 90
Day 60 and Day 90
ACM+ at Day 28, Day 60, and Day 90
Time Frame: Day 28, Day 60, and Day 90
Improvements in oxygenation measured as change from baseline in PaO2/FiO2 ratio up to and including Day 28 (or discharge, whichever is earlier)
Up to and including Day 28 or until Discharge (whichever is earlier)
Incidence of new invasive mechanical ventilation use during the study up to and including Day 28
Up to and including Day 28
Ventilator-free days up to and including Day 28
Up to and including Day 28
- +14 more secondary outcomes
Study Arms (2)
Cohort A: vilobelimab
EXPERIMENTALCohort A: placebo
PLACEBO COMPARATORInterventions
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)
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)
Eligibility Criteria
You may not qualify if:
- ARDS Severity of moderate or severe based on PaO2/FiO2 or SpO2/FiO2 assessment at the time of randomization
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PPD Development, LPlead
- Biomedical Advanced Research and Development Authoritycollaborator
- InflaRx GmbHcollaborator
- Edesa Biotech Inc.collaborator
- Genentech, Inc.collaborator
Study Sites (36)
University of Alabama Hospital
Birmingham, Alabama, 35233-1932, United States
Community Regional Medical Center
Fresno, California, 93721-1324, United States
Long Beach Memorial Medical Center
Long Beach, California, 90806-1701, United States
University of California Irvine Medical Center
Orange, California, 92868-3201, United States
University of California Davis Medical Center - Pulmonary Medicine
Sacramento, California, 95816-4300, United States
Denver Health Hospital and Authority
Denver, Colorado, 80204-4532, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010-3017, United States
Nova Clinical Research
Bradenton, Florida, 34209-4617, United States
North Florida / South Georgia Veterans Health System
Gainesville, Florida, 32608-1135, United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239, United States
St. Luke's Boise Medical Center
Boise, Idaho, 83712-6241, United States
Northshore University Healthsystem Research Institute
Evanston, Illinois, 60201-1700, United States
OSF Saint Francis Medical Center-
Peoria, Illinois, 61637-0001, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805-0001, United States
University of Michigan Hospital
Ann Arbor, Michigan, 48109-5000, United States
Henry Ford Health Hospital
Detroit, Michigan, 48202-2608, United States
Mayo Clinic
Rochester, Minnesota, 55905-0001, United States
Renown Institute for Heart & Vascular Health
Reno, Nevada, 89502-1576, United States
Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901-1928, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065-6007, United States
Montefiore Hospital - Moses Campus
The Bronx, New York, 10467, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-0001, United States
Durham VA Medical Center
Durham, North Carolina, 27705-3875, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106-1716, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Mercy Health - St. Vincent Medical Center
Toledo, Ohio, 43608-2603, United States
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104-3609, United States
Oregon Health and Science University
Portland, Oregon, 97239-3011, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425-8908, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-0004, United States
Baylor All Saints Medical Center
Fort Worth, Texas, 76104-4110, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
Intermountain Medical Center
Murray, Utah, 84107-5701, United States
University of Virginia Health System
Charlottesville, Virginia, 22908-0816, United States
Swedish Medical Center
Seattle, Washington, 98122-4379, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- The overall 2-step randomization scheme will be implemented. * Randomization Level 1 will be open-label, assigning an eligible patient to one of the available treatment cohorts. * Randomization Level 2 will be double-blinded and will randomize participants at a 1:1 ratio to receive either IP or placebo within a specific cohort. Thus, the PPD blinded team, site blinded staff members, and participants/legal authorized representative will be considered blinded to study treatment assignment (either IP or placebo) throughout the course of the study. To preserve the integrity of the study blind, an unblinded pharmacist at each site will be responsible for the reconstitution and dispensation of all study drugs and placebos and will endeavor to ensure that there are no observable differences between the treatment groups (IP or placebo) when dispensing the study materials.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2024
First Posted
November 22, 2024
Study Start
June 21, 2025
Primary Completion (Estimated)
July 1, 2028
Study Completion (Estimated)
September 1, 2028
Last Updated
March 25, 2026
Record last verified: 2026-02