Recruiting

Phase 2

Innovative TherapiesJUST BREATHE, Breathing Life Into Innovative Therapies for ARDS (Master Record)

Sponsor:

PPD Development, LP

Code:

NCT06703073

Conditions

Acute Respiratory Distress Syndrome (ARDS)

ARDS

ARDS (Acute Respiratory Distress Syndrome)

Acute Respiratory Distress Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cohort A: vilobelimab

Cohort A: placebo

Cohort B: paridiprubart

Cohort B: placebo

Cohort C: bevacizumab

Study Details

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. Participants will be randomized to receive either a placebo or one of the active treatments.

This record describes the default procedures and analyses for all cohorts. Each specific cohort may have additional eligibility requirements, safety and efficacy procedures, or endpoints, which will be described in the corresponding intervention-specific records on clinicaltrials.gov listed below in the detailed description.

Conditions

Acute Respiratory Distress Syndrome (ARDS)

ARDS

ARDS (Acute Respiratory Distress Syndrome)

Acute Respiratory Distress Syndrome

Study ID

NCT06703073

Start date

Jun 10, 2025

Status verified date

Jun, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria

Each participant must meet all of the following criteria to be enrolled in this study:

Participant (or their Legally Authorized Representative (LAR)) provides informed consent and agrees to comply with protocol requirements
Participant is at least 18 years of age or older at the time of consent.
Participant with signs and symptoms of ARDS according to the Berlin definition of ARDS.

Note that participants on noninvasive ventilation may be screened.

Participant of childbearing potential must agree to either abstinence or use at least one primary form of contraception, not including hormonal contraception, from the time of screening through Day 28. Additional cohort-specific requirements may apply
Participant agrees to not participate in another investigational interventional study while participating in this study (i.e., through Day 90).

Exclusion Criteria

Participants will be excluded from the study if any of the following apply:

Participant with ARDS or at risk of developing ARDS due to the following reasons: trauma, large volume aspiration, or transfusion.
Participant with pulmonary edema due to cardiogenic pulmonary edema/fluid overload or hypoxemia primarily attributable atelectasis, in the absence of a predisposing risk factor for ARDS.
Participant who demonstrates an improvement in oxygenation and ventilatory support 24 hours prior to or during screening up to randomization, such that per investigator clinical judgement, the participant is expected to have significant improvement in lung function over subsequent 24 hours regardless of additional interventions.
Participant is known to be pregnant, nursing, or with a positive (urine and/or serum test) pregnancy test.
Participant is anticipated to be transferred to another hospital which is not a study site within 72 hours.
Participant is not expected to survive for 72 hours.
Participant has been on invasive mechanical ventilation or ECMO for ARDS for more than 48 hours for ARDS at the time of consent.
Participant has an underlying clinical condition where, in the opinion of the Investigator and based on their clinical judgement, it would be extremely unlikely that the participant would come off ventilation
Participant has severe COPD requiring continuous long-term home oxygen therapy or mechanical ventilation (noninvasive ventilation or via tracheotomy) except for CPAP or bi-level positive airway pressure used solely for sleep-disordered breathing.
Participant has interstitial lung disease or idiopathic pulmonary fibrosis requiring continuous chronic home oxygen therapy.
Participant has NY Heart Association Class IV congestive heart failure.
Participant has a known allergy to any study medication or any of its excipients.
Participant is receiving systemic immunosuppressive therapy for solid organ or hematopoietic cancer or transplant anti-rejection medication therapy OR systemic immunosuppressive corticosteroids (prednisone ≥20 mg daily or equivalent). NOTE: Patients onreceiving chronic low dose immunosuppressive therapy may be enrolled(e.g., prednisone <20 mg/day or equivalent) and patients on stable, long-term maintenance immunosuppression (e.g., tacrolimus, mycophenolate, orsirolimus) and patients receiving physiologic replacement and hormonal therapies for breast cancer (e.g., tamoxifen, letrozole) or prostate cancer (leuprolide, bicalutamide) for >60 days may be eligible at the investigator's discretion of the investigator in consultation with the medical monitor.
Participant is receiving ongoing cytotoxic chemotherapy (IV or oral), OR combination targeted/immunotherapy regimens for cancer within the past 60 days. Note: Participants receiving non-myelosuppressive cancer therapy (e.g., hormonal therapy or selected targeted / immunotherapy regimens) may be eligible if therapy has been stable ≥60 days; The use of hydroxyurea to manage patients with chronic myeloid leukemia, polycythemia vera, essential thrombocythemia or sickle cell disease is permitted.
Participant received treatment with an investigational immunomodulator or immunosuppressant drugs within 5 half-lives or 30 days (whichever is longer) before randomization.
Participant with concurrent infections or history of the following:

1. Known active tuberculosis,
2. Known active Hepatitis B, or
3. HIV and a CD4 count less than 50 or a detectable viral load of >200 copies/mL HIV RNA.

Participant received treatment with any other investigational drugs within 30 days prior to consent.
Participant had a history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess within 28 days of screening or inadequate wound healing secondary to major thoracoabdominal surgery at the time of screening.
Participant is considered by the investigator, for any reason, to be an unsuitable candidate for the study.

Participant may have additional cohort-specific requirements.

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort A: vilobelimab

placebo comparator: Cohort A: placebo

experimental: Cohort B: paridiprubart

placebo comparator: Cohort B: placebo

experimental: Cohort C: bevacizumab

placebo comparator: Cohort C: placebo

Interventions

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)

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)

Cohort B: paridiprubart

Administered as a single IV dose of 15 mg/kg up to maximum of 1440 mg on Day 1

Cohort B: placebo

Administered as a single IV dose of placebo on Day 1

Cohort C: bevacizumab

Administered as a single IV dose of 500 mg on Day 1

Cohort C: placebo

Administered as a single IV dose of placebo on Day 1

Primary outcome measure

All-cause mortality (ACM) rate at Day 28 [ Time Frame: Day 28 ]

Central Contacts and Locations

Central contacts

Just Breathe Trial Team

Please email crgjustbreathealerts.sm@thermofisher.com

Locations

Community Regional Medical Center

Recruiting

Fresno, California, United States, 93721-1324

Long Beach Memorial Medical Center

Recruiting

Long Beach, California, United States, 90806-1701

University of California Irvine Medical Center

Recruiting

Orange, California, United States, 92868-3201

University of California Davis Medical Center - Pulmonary Medicine

Recruiting

Sacramento, California, United States, 95816-4300

Stanford Medical Center

Recruiting

Stanford, California, United States, 94305-2200

MedStar Washington Hospital Center

Recruiting

Washington D.C., District of Columbia, United States, 20010-3017

Nova Clinical Research

Recruiting

Bradenton, Florida, United States, 34209-4617

North Florida / South Georgia Veterans Health System

Recruiting

Gainesville, Florida, United States, 32608-1135

Sarasota Memorial Hospital

Recruiting

Sarasota, Florida, United States, 34239

St. Luke's Boise Medical Center

Recruiting

Boise, Idaho, United States, 83712-6241

OSF Saint Francis Medical Center-

Recruiting

Peoria, Illinois, United States, 61637-0001

Lahey Hospital and Medical Center

Recruiting

Burlington, Massachusetts, United States, 01805-0001

University of Michigan Hospital

Recruiting

Ann Arbor, Michigan, United States, 48109-5000

Henry Ford Health Hospital

Recruiting

Detroit, Michigan, United States, 48202-2608

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905-0001

Robert Wood Johnson Medical School

Recruiting

New Brunswick, New Jersey, United States, 08901-1928

Montefiore Hospital - Moses Campus

Recruiting

The Bronx, New York, United States, 10467

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599-0001

Durham VA Medical Center

Recruiting

Durham, North Carolina, United States, 27705-3875

Mercy Health - St. Vincent Medical Center

Recruiting

Toledo, Ohio, United States, 43608-2603

The University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104-3609

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239-3011

Medical University of South Carolina (MUSC)

Recruiting

Charleston, South Carolina, United States, 29425-8908

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232-0004

Baylor All Saints Medical Center

Recruiting

Fort Worth, Texas, United States, 76104-4110

Intermountain Medical Center

Recruiting

Murray, Utah, United States, 84107-5701

Swedish Medical Center

Recruiting

Seattle, Washington, United States, 98122-4379

More Information

Sponsor

PPD Development, LP

Last update posted

Jul 31, 2026

Last verified

Jun, 2026

Keywords

BARDA
JUST BREATHE
ARDS
Acute Respiratory Distress Syndrome
Acute Respiratory Failure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by PPD Development, LP on 2026-07-31.