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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Acute Respiratory Distress Syndrome (ARDS), ARDS, ARDS (Acute Respiratory Distress Syndrome), Acute Respiratory Distress Syndrome

In brief

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.

Key facts

Study ID

NCT06701669

Run by

PPD Development, LP

People needed

200

Starts

2025-06-10

Expected to finish

2028-09-01

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Swedish Medical Center — Seattle, Washington, United States (enrolling)
• Community Regional Medical Center — Fresno, California, United States (enrolling)
• Long Beach Memorial Medical Center — Long Beach, California, United States (enrolling)
• University of California Irvine Medical Center — Orange, California, United States (enrolling)
• University of California Davis Medical Center - Pulmonary Medicine — Sacramento, California, United States (enrolling)
• Stanford Medical Center — Stanford, California, United States (enrolling)
• Denver Health Hospital and Authority — Denver, Colorado, United States (enrolling)
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States (enrolling)
• Nova Clinical Research — Bradenton, Florida, United States (enrolling)
• North Florida / South Georgia Veterans Health System — Gainesville, Florida, United States (enrolling)
• Sarasota Memorial Hospital — Sarasota, Florida, United States (enrolling)
• St. Luke's Boise Medical Center — Boise, Idaho, United States (enrolling)
• Henry Ford Health Hospital — Detroit, Michigan, United States (enrolling)
• Mayo Clinic — Rochester, Minnesota, United States (enrolling)
• Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States (enrolling)
• Montefiore Hospital - Moses Campus — The Bronx, New York, United States (enrolling)
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)
• Durham VA Medical Center — Durham, North Carolina, United States (enrolling)
• Mercy Health - St. Vincent Medical Center — Toledo, Ohio, United States (enrolling)
• The University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States (enrolling)
• Oregon Health and Science University — Portland, Oregon, United States (enrolling)
• Medical University of South Carolina (MUSC) — Charleston, South Carolina, United States (enrolling)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
• Baylor All Saints Medical Center — Fort Worth, Texas, United States (enrolling)
• Intermountain Medical Center — Murray, Utah, United States (enrolling)

Full record on ClinicalTrials.gov

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