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Clinical Trials in the USA / NCT06703073
Recruiting Phase 2

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

NCT06703073 · tracked via the Priya Life Science USA tracker
Sponsor
PPD Development, LP
Phase
Phase 2
Started
2025-06-10
Last updated
2026-07-31

Condition(s) studied

Acute Respiratory Distress Syndrome (ARDS)ARDSARDS (Acute Respiratory Distress Syndrome)Acute Respiratory Distress Syndrome

Investigational drug(s) / intervention(s)

Cohort A: vilobelimabCohort A: placeboCohort B: paridiprubartCohort B: placeboCohort C: bevacizumabCohort C: placebo

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (41)

FacilityCityRegionStatus
University of Alabama Hospital Birmingham Alabama Not Yet Recruiting
Community Regional Medical Center Fresno California Recruiting
Long Beach Memorial Medical Center Long Beach California Recruiting
University of California Irvine Medical Center Orange California Recruiting
University of California Davis Medical Center - Pulmonary Medicine Sacramento California Recruiting
Stanford Medical Center Stanford California Recruiting
Denver Health Hospital and Authority Denver Colorado Not Yet Recruiting
MedStar Washington Hospital Center Washington D.C. District of Columbia Recruiting
Nova Clinical Research Bradenton Florida Recruiting
North Florida / South Georgia Veterans Health System Gainesville Florida Recruiting
Sarasota Memorial Hospital Sarasota Florida Recruiting
St. Luke's Boise Medical Center Boise Idaho Recruiting
Northshore University Healthsystem Research Institute Evanston Illinois Not Yet Recruiting
OSF Saint Francis Medical Center- Peoria Illinois Recruiting
Tufts Medical Center Boston Massachusetts Not Yet Recruiting
Lahey Hospital and Medical Center Burlington Massachusetts Recruiting
University of Michigan Hospital Ann Arbor Michigan Recruiting
Henry Ford Health Hospital Detroit Michigan Recruiting
Mayo Clinic Rochester Minnesota Recruiting
Renown Institute for Heart & Vascular Health Reno Nevada Withdrawn
Robert Wood Johnson Medical School New Brunswick New Jersey Recruiting
Memorial Sloan Kettering Cancer Center New York New York Not Yet Recruiting
Weill Cornell Medical College New York New York Not Yet Recruiting
Montefiore Hospital - Moses Campus The Bronx New York Recruiting
Westchester Medical Center Valhalla New York Not Yet Recruiting
University of North Carolina at Chapel Hill Chapel Hill North Carolina Recruiting
Durham VA Medical Center Durham North Carolina Recruiting
Duke Lung Transplant Clinic - Clinic 2F/2G - PPDS Durham North Carolina Not Yet Recruiting
University Hospitals Cleveland Medical Center Cleveland Ohio Not Yet Recruiting
Cleveland Clinic Cleveland Ohio Not Yet Recruiting
Mercy Health - St. Vincent Medical Center Toledo Ohio Recruiting
The University of Oklahoma Health Sciences Center Oklahoma City Oklahoma Recruiting
Oregon Health and Science University Portland Oregon Recruiting
Medical University of South Carolina (MUSC) Charleston South Carolina Recruiting
Vanderbilt University Medical Center Nashville Tennessee Recruiting
Baylor All Saints Medical Center Fort Worth Texas Recruiting
Baylor St Luke's Medical Center Houston Texas Not Yet Recruiting
Houston Methodist Hospital Houston Texas Not Yet Recruiting
Intermountain Medical Center Murray Utah Recruiting
University of Virginia Health System Charlottesville Virginia Not Yet Recruiting

+ 1 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06703073 on ClinicalTrials.gov ↗ ← All trials in the USA