JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort B: Paridiprubart
NCT06701669 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2026-05-08
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.
Conditions
- Acute Respiratory Distress Syndrome (ARDS)
- ARDS
- ARDS (Acute Respiratory Distress Syndrome)
- Acute Respiratory Distress Syndrome
Interventions
- DRUG
-
Cohort B: paridiprubart
Administered as a single IV dose of 15 mg/kg up to maximum of 1440 mg on Day 1
- DRUG
-
Cohort B: placebo
Administered as a single IV dose of placebo on Day 1
Sponsors & Collaborators
-
Biomedical Advanced Research and Development Authority
collaborator FED -
InflaRx GmbH
collaborator INDUSTRY -
Edesa Biotech Inc.
collaborator INDUSTRY -
Genentech, Inc.
collaborator INDUSTRY -
PPD Development, LP
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-06-10
- Primary Completion
- 2028-07-31
- Completion
- 2028-09-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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