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)

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Respiratory Distress Syndrome; ARDS; Acute Respiratory Distress Syndrome (ARDS); ARDS (Acute Respiratory Distress Syndrome)
• Intervention / Treatment: Drug: Cohort A: vilobelimab; Drug: Cohort A: placebo

Detailed Description

This is a master protocol for a Phase 2 platform clinical trial to evaluate host-directed therapeutic candidates (i.e., investigational product, IP) for the treatment of hospitalized participants diagnosed with ARDS. The safety and efficacy of each IP will be studied within its own cohort (IP versus Placebo). All patients will continue to receive standard treatments for ARDS as per the investigator. An individual participant will complete the study in approximately 90 days. The study will include a screening period (<24 hours from providing informed consent to treatment), in-hospital treatment period with IP/placebo starting on Day 1 through discharge from the hospital, and a follow-up period after discharge from the hospital through the end of study (Day 90 + 2 weeks). Outcome data will be assembled for each patient over time (such as ventilatory status, oxygenation, and survival). Functional status using the WHO Ordinal scale and Karnofsky scale will be collected. Resource utilization will be calculated (length of stay in a critical care setting, days intubated, and survival).

All participants will undergo a series of physical exams, laboratory assessments/biomarker collections, ECG, Chest X-ray or CT scan, and questionnaires through Day 90. Exploratory biomarkers will be evaluated over time to facilitate clinical learning. This record only includes information relevant to the vilobelimab cohort.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Just Breathe Trial Team; Phone Number: Please email; Email: crgjustbreathealerts.sm@thermofisher.com

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233-1932
      • Not yet recruiting
      • University of Alabama Hospital
  • California
    • Fresno, California, United States, 93721-1324
      • Recruiting
      • Community Regional Medical Center
    • Long Beach, California, United States, 90806-1701
      • Recruiting
      • Long Beach Memorial Medical Center
    • Orange, California, United States, 92868-3201
      • Recruiting
      • University of California Irvine Medical Center
    • Sacramento, California, United States, 95816-4300
      • Recruiting
      • University of California Davis Medical Center - Pulmonary Medicine
  • Colorado
    • Denver, Colorado, United States, 80204-4532
      • Recruiting
      • Denver Health Hospital and Authority
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010-3017
      • Recruiting
      • Medstar Washington Hospital Center
  • Florida
    • Bradenton, Florida, United States, 34209-4617
      • Recruiting
      • Nova Clinical Research
    • Gainesville, Florida, United States, 32608-1135
      • Recruiting
      • North Florida / South Georgia Veterans Health System
    • Sarasota, Florida, United States, 34239
      • Recruiting
      • Sarasota Memorial Hospital
  • Idaho
    • Boise, Idaho, United States, 83712-6241
      • Recruiting
      • St. Luke's Boise Medical Center
  • Illinois
    • Evanston, Illinois, United States, 60201-1700
      • Not yet recruiting
      • Northshore University Healthsystem Research Institute
    • Peoria, Illinois, United States, 61637-0001
      • Recruiting
      • OSF Saint Francis Medical Center-
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Not yet recruiting
      • Tufts Medical Center
    • Burlington, Massachusetts, United States, 01805-0001
      • Recruiting
      • Lahey Hospital and Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-5000
      • Recruiting
      • University of Michigan Hospital
    • Detroit, Michigan, United States, 48202-2608
      • Recruiting
      • Henry Ford Health Hospital
  • Minnesota
    • Rochester, Minnesota, United States, 55905-0001
      • Recruiting
      • Mayo Clinic
  • Nevada
    • Reno, Nevada, United States, 89502-1576
      • Withdrawn
      • Renown Institute for Heart & Vascular Health
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901-1928
      • Recruiting
      • Robert Wood Johnson Medical School
  • New York
    • New York, New York, United States, 10065-6007
      • Not yet recruiting
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10065-8722
      • Not yet recruiting
      • Weill Cornell Medical College
    • The Bronx, New York, United States, 10467
      • Recruiting
      • Montefiore Hospital - Moses Campus
    • Valhalla, New York, United States, 10595-1530
      • Not yet recruiting
      • Westchester Medical Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599-0001
      • Recruiting
      • University of North Carolina at Chapel Hill
    • Durham, North Carolina, United States, 27705-3875
      • Recruiting
      • Durham VA Medical Center
    • Durham, North Carolina, United States, 27710-4000
      • Not yet recruiting
      • Duke Lung Transplant Clinic - Clinic 2F/2G - PPDS
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Not yet recruiting
      • Cleveland Clinic
    • Cleveland, Ohio, United States, 44106-1716
      • Not yet recruiting
      • University Hospitals Cleveland Medical Center
    • Toledo, Ohio, United States, 43608-2603
      • Recruiting
      • Mercy Health - St. Vincent Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104-3609
      • Recruiting
      • The University of Oklahoma Health Sciences Center
  • Oregon
    • Portland, Oregon, United States, 97239-3011
      • Recruiting
      • Oregon Health and Science University
  • South Carolina
    • Charleston, South Carolina, United States, 29425-8908
      • Recruiting
      • Medical University of South Carolina (MUSC)
  • Tennessee
    • Nashville, Tennessee, United States, 37232-0004
      • Recruiting
      • Vanderbilt University Medical Center
  • Texas
    • Fort Worth, Texas, United States, 76104-4110
      • Recruiting
      • Baylor All Saints Medical Center
    • Houston, Texas, United States, 77030
      • Not yet recruiting
      • Houston Methodist Hospital
    • Houston, Texas, United States, 77030-4202
      • Not yet recruiting
      • Baylor St Luke's Medical Center
  • Utah
    • Murray, Utah, United States, 84107-5701
      • Recruiting
      • Intermountain Medical Center
  • Virginia
    • Charlottesville, Virginia, United States, 22908-0816
      • Not yet recruiting
      • University of Virginia Health System
  • Washington
    • Seattle, Washington, United States, 98122-4379
      • Recruiting
      • Swedish Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

The following inclusion criteria are in addition to the exclusion criteria specified in the Master Protocol NCT06703073.

• ARDS Severity of moderate or severe based on PaO2/FiO2 or SpO2/FiO2 assessment at the time of randomization

Exclusion Criteria:

• No additional exclusion criteria beyond the exclusion criteria specified in the Master Protocol NCT06703073.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort A: vilobelimab	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)
Placebo Comparator: Cohort A: placebo	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
All-cause mortality (ACM) rate at Day 28	Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ACM at Day 60 and Day 90		Day 60 and Day 90
ACM+ at Day 28, Day 60, and Day 90	ACM+ composite score will be constructed by combining ACM and participant-relevant, infection-related Adverse Events (AE) from the MedDRA toxic/septic shock standardized MedDRA queries.	Time Frame: Day 28, Day 60, and Day 90
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
Proportion of participants alive and free of mechanical ventilation at Days 28, 60, and 90		Days 28, 60, and 90
Time to recover gas exchange to a PaO2/FiO2 ≥ 300 measured on 2 consecutive days during the first 28 days after informed consent		Up to and including Day 28
Extracorporeal Membrane Oxygenation (ECMO) free days up to and including Day 28		up to and including Day 28
Incidence of participants with new ECMO use during the study up to and including Day 28.		up to and including Day 28
Proportion of participants alive and free of ECMO at Days 28, 60, and 90		Days 28, 60, and 90
Days of hospitalization up to and including Day 28		up to and including Day 28
Days of ICU stay up to and including Day 28		up to and including Day 28
Incidence and severity of adverse events (AEs) /adverse event of special interest (AESI) / serious adverse event (SAEs)		Through 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)
Proportion of participants achieving a ≥2-point improvement from baseline in the World Health Organization (WHO) 8-levels ordinal scale (from 0-8)		While Hospitalized (up to 90 days)
Time to an improvement of one category and two categories from baseline using the WHO 8-levels ordinal scale (from 0-8) at Days 28, 60, and 90 (while hospitalized)		While Hospitalized (up to 90 days)
Mean change in the WHO 8-levels ordinal scale from baseline through Day 90 (while hospitalized)		While Hospitalized (up to 90 days)
Proportion of participants who improve clinical status as measured by the Karnofsky scale	The Karnofsky scale is used to assess the general condition of the patient. Scores range from 0 to 100 with higher scores indicating better functional ability.	Post hospitalization through Day 90
Change in St. George's Respiratory Questionnaire (SGRQ) from hospital discharge to Day 60 and to Day 90	The SGRQ comprises of 50 items and consists of two parts. The first part pertains to symptoms and the second pertains to functional status as well as social and psychological impact of disease. Overall scores range between 0 and 100 with higher scores indicating more limitations.	From hospital discharge to Day 60 and to Day 90
Change in Short Form Health Survey (SF-12) from hospital discharge to Day 60 and to Day 90	The SF-12 is a self-reported outcome measure composed by 12 items which examine eight dimensions of physical and mental health. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.	from hospital discharge to Day 60 and to Day 90

Collaborators and Investigators

• Sponsor: PPD Development, LP
• Collaborators: Genentech, Inc.; Biomedical Advanced Research and Development Authority; InflaRx GmbH; Edesa Biotech Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: November 20, 2024
• First Submitted That Met QC Criteria: November 20, 2024
• First Posted (Actual): November 22, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: ARDS; Acute Respiratory Distress Syndrome; Acute Respiratory Failure; BARDA; JUST BREATHE
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Lung Injury; Respiratory Distress Syndrome; Acute Lung Injury; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Complement Inactivating Agents; Vilobelimab
• Other Study ID Numbers: BP-ARDS-P2-001 (vilobelimab); 75A50124C00001 (Other Grant/Funding Number: Biomedical Advanced Research and Development Authority (BARDA))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No