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

NCT ID: NCT06701682

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-21

Study Completion Date

2028-09-30

Brief Summary

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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.

Detailed Description

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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. This record only includes information relevant to the vilobelimab cohort.

Conditions

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

Keywords

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BARDA JUST BREATHE ARDS Acute Respiratory Distress Syndrome Acute Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
The overall 2-step randomization scheme will be implemented.

* Randomization Level 1 will be open-label, assigning an eligible patient to one of the available treatment cohorts.
* Randomization Level 2 will be double-blinded and will randomize participants at a 1:1 ratio to receive either IP or placebo within a specific cohort. Thus, the PPD blinded team, site blinded staff members, and participants/legal authorized representative will be considered blinded to study treatment assignment (either IP or placebo) throughout the course of the study.

To preserve the integrity of the study blind, an unblinded pharmacist at each site will be responsible for the reconstitution and dispensation of all study drugs and placebos and will endeavor to ensure that there are no observable differences between the treatment groups (IP or placebo) when dispensing the study materials.

Study Groups

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Cohort A: vilobelimab

Group Type EXPERIMENTAL

Cohort A: vilobelimab

Intervention Type 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

Group Type PLACEBO_COMPARATOR

Cohort A: placebo

Intervention Type 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)

Interventions

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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)

Intervention Type 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)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ARDS Severity of moderate or severe based on PaO2/FiO2 or SpO2/FiO2 assessment at the time of randomization
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biomedical Advanced Research and Development Authority

FED

Sponsor Role collaborator

InflaRx GmbH

INDUSTRY

Sponsor Role collaborator

Edesa Biotech Inc.

INDUSTRY

Sponsor Role collaborator

Genentech, Inc.

INDUSTRY

Sponsor Role collaborator

PPD Development, LP

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Community Regional Medical Center

Fresno, California, United States

Site Status RECRUITING

Long Beach Memorial Medical Center

Long Beach, California, United States

Site Status RECRUITING

University of California Irvine Medical Center

Orange, California, United States

Site Status RECRUITING

University of California Davis Medical Center - Pulmonary Medicine

Sacramento, California, United States

Site Status RECRUITING

Denver Health Hospital and Authority

Denver, Colorado, United States

Site Status RECRUITING

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Site Status RECRUITING

Nova Clinical Research

Bradenton, Florida, United States

Site Status RECRUITING

North Florida / South Georgia Veterans Health System

Gainesville, Florida, United States

Site Status RECRUITING

Sarasota Memorial Hospital

Sarasota, Florida, United States

Site Status RECRUITING

St. Luke's Boise Medical Center

Boise, Idaho, United States

Site Status RECRUITING

OSF Saint Francis Medical Center-

Peoria, Illinois, United States

Site Status RECRUITING

Tufts Medical Center

Boston, Massachusetts, United States

Site Status NOT_YET_RECRUITING

Lahey Hospital and Medical Center

Burlington, Massachusetts, United States

Site Status RECRUITING

University of Michigan Hospital

Ann Arbor, Michigan, United States

Site Status RECRUITING

Henry Ford Health Hospital

Detroit, Michigan, United States

Site Status RECRUITING

Mayo Clinic

Rochester, Minnesota, United States

Site Status RECRUITING

Renown Institute for Heart & Vascular Health

Reno, Nevada, United States

Site Status WITHDRAWN

Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

Site Status RECRUITING

Montefiore Hospital - Moses Campus

The Bronx, New York, United States

Site Status RECRUITING

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status RECRUITING

Durham VA Medical Center

Durham, North Carolina, United States

Site Status RECRUITING

Mercy Health - St. Vincent Medical Center

Toledo, Ohio, United States

Site Status RECRUITING

The University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

Oregon Health and Science University

Portland, Oregon, United States

Site Status RECRUITING

Medical University of South Carolina (MUSC)

Charleston, South Carolina, United States

Site Status RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status RECRUITING

Baylor All Saints Medical Center

Fort Worth, Texas, United States

Site Status RECRUITING

Houston Methodist Hospital

Houston, Texas, United States

Site Status NOT_YET_RECRUITING

Intermountain Medical Center

Murray, Utah, United States

Site Status RECRUITING

Swedish Medical Center

Seattle, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Just Breathe Trial Team

Role: CONTACT

Phone: Please email

Email: [email protected]

Other Identifiers

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75A50124C00001

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

BP-ARDS-P2-001 (vilobelimab)

Identifier Type: -

Identifier Source: org_study_id