Recruiting

Phase 2

VilobelimabJUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort A: Vilobelimab

Sponsor:

PPD Development, LP

Code:

NCT06701682

Conditions

Acute Respiratory Distress Syndrome (ARDS)

ARDS

ARDS (Acute Respiratory Distress Syndrome)

Acute Respiratory Distress Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cohort A: vilobelimab

Cohort A: placebo

Study Details

Brief 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 A: Participants will be randomized to receive either a placebo or vilobelimab.

This record describes the default procedures and analyses for Cohort A. 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

Study ID

NCT06701682

Start date

Jun 21, 2025

Status verified date

Jun, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

The following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol NCT06703073.

Participant with established cirrhosis and a modified Child-Pugh Score of 12 or greater

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort A: vilobelimab

placebo comparator: Cohort A: placebo

Interventions

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)

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)

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Just Breathe Trial Team

Please email crgjustbreathealerts.sm@thermofisher.com

Locations

Community Regional Medical Center

Recruiting

Fresno, California, United States, 93721-1324

Long Beach Memorial Medical Center

Recruiting

Long Beach, California, United States, 90806-1701

University of California Irvine Medical Center

Recruiting

Orange, California, United States, 92868-3201

University of California Davis Medical Center - Pulmonary Medicine

Recruiting

Sacramento, California, United States, 95816-4300

Stanford Medical Center

Recruiting

Stanford, California, United States, 94305-2200

Denver Health Hospital and Authority

Recruiting

Denver, Colorado, United States, 80204-4532

MedStar Washington Hospital Center

Recruiting

Washington D.C., District of Columbia, United States, 20010-3017

Nova Clinical Research

Recruiting

Bradenton, Florida, United States, 34209-4617

North Florida / South Georgia Veterans Health System

Recruiting

Gainesville, Florida, United States, 32608-1135

Sarasota Memorial Hospital

Recruiting

Sarasota, Florida, United States, 34239

St. Luke's Boise Medical Center

Recruiting

Boise, Idaho, United States, 83712-6241

OSF Saint Francis Medical Center-

Recruiting

Peoria, Illinois, United States, 61637-0001

Lahey Hospital and Medical Center

Recruiting

Burlington, Massachusetts, United States, 01805-0001

University of Michigan Hospital

Recruiting

Ann Arbor, Michigan, United States, 48109-5000

Henry Ford Health Hospital

Recruiting

Detroit, Michigan, United States, 48202-2608

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905-0001

Robert Wood Johnson Medical School

Recruiting

New Brunswick, New Jersey, United States, 08901-1928

Montefiore Hospital - Moses Campus

Recruiting

The Bronx, New York, United States, 10467

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599-0001

Durham VA Medical Center

Recruiting

Durham, North Carolina, United States, 27705-3875

Mercy Health - St. Vincent Medical Center

Recruiting

Toledo, Ohio, United States, 43608-2603

The University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104-3609

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239-3011

Medical University of South Carolina (MUSC)

Recruiting

Charleston, South Carolina, United States, 29425-8908

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232-0004

Baylor All Saints Medical Center

Recruiting

Fort Worth, Texas, United States, 76104-4110

Intermountain Medical Center

Recruiting

Murray, Utah, United States, 84107-5701

Swedish Medical Center

Recruiting

Seattle, Washington, United States, 98122-4379

More Information

Sponsor

PPD Development, LP

Last update posted

Jul 31, 2026

Last verified

Jun, 2026

Keywords

BARDA
JUST BREATHE
ARDS
Acute Respiratory Distress Syndrome
Acute Respiratory Failure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by PPD Development, LP on 2026-07-31.