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

Conditions

• ARDS
• ARDS (Acute Respiratory Distress Syndrome)
• Acute Respiratory Distress Syndrome
• Acute Respiratory Distress Syndrome (ARDS)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cohort A: vilobelimab — DRUG
  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 — DRUG
  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 — DRUG
  Administered as a single IV dose of 15 mg/kg up to maximum of 1440 mg on Day 1
• Cohort B: placebo — DRUG
  Administered as a single IV dose of placebo on Day 1
• Cohort C: bevacizumab — DRUG
  Administered as a single IV dose of 500 mg on Day 1
• Cohort C: placebo — DRUG
  Administered as a single IV dose of placebo on Day 1

Study Details

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.

Key Dates

Start date

Jun 10, 2025

Status verified

Apr 2026

Primary completion

Jul 31, 2028

Completion

Sep 30, 2028

Study Design

Enrollment

600 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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

Primary Outcome Measure

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

Central Contacts

• Just Breathe Trial Team
  Please email
  [email protected]

Locations (40)

Find similar trials in Birmingham, AL

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