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

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.

Conditions

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

Interventions

DRUG

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)

DRUG

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)

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

DRUG

Cohort C: bevacizumab

Administered as a single IV dose of 500 mg on Day 1

DRUG

Cohort C: 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