NCT06703073

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

Phase 2 Clinical Platform Trial Investigating Multiple Therapeutic Options for the Treatment of Hospitalized Patients With Acute Respiratory Distress Syndrome (ARDS)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: PPD Development, LP · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a master protocol for a Phase 2 platform clinical trial to evaluate host-directed therapeutic candidates (i.e., investigational product, IP) for the treatment of hospitalized participants diagnosed with ARDS. The safety and efficacy of each IP will be studied within its own cohort (IP versus Placebo). All patients will continue to receive standard treatments for ARDS as per the investigator. An individual participant will complete the study in approximately 90 days. The study will include a screening period (\<24 hours from providing informed consent to treatment), in-hospital treatment period with IP/placebo starting on Day 1 through discharge from the hospital, and a follow-up period after discharge from the hospital through the end of study (Day 90 + 2 weeks). Outcome data will be assembled for each patient over time (such as ventilatory status, oxygenation, and survival). Functional status using the WHO Ordinal scale and Karnofsky scale will be collected. Resource utilization will be calculated (length of stay in a critical care setting, days intubated, and survival). All participants will undergo a series of physical exams, laboratory assessments/biomarker collections, ECG, Chest X-ray or CT scan, and questionnaires through Day 90. Exploratory biomarkers will be evaluated over time to facilitate clinical learning. For information specific to each intervention included in this platform trial, please refer to the below corresponding, separate, clinicaltrials.gov records: Vilobelimab NCT06701682 ; Paridiprubart NCT06701669 ; Bevacizumab NCT06701656

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-06-10
• Primary completion: 2028-07-01
• Completion: 2028-09-01
• First posted: 2024-11-25
• Last updated: 2026-03-25

Locations

36 sites across 1 country: United States

Regulatory

• FDA-regulated drug study