JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort B: Paridiprubart

NCT06701669 · 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 B: paridiprubartCohort B: placebo

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

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.

Cohort B: Participants will be randomized to receive either a placebo or paridiprubart.

This record describes the default procedures and analyses for Cohort B. Please see NCT06703073 for information on the BP-ARDS-P2-001 Master Protocol.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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: The following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol NCT06703073. * Participant has a known allergy or known hypersensitivity to paridiprubart or its excipients, including polysorbate 80 * Participant with established cirrhosis and a modified Child-Pugh Score of 12 or greater

Primary outcome measure(s)

All-cause mortality (ACM) rate at Day 28 — Day 28

Trial sites (41)

Facility	City	Region	Status
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	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 NCT06701669 on ClinicalTrials.gov ↗ ← All trials in the USA