Acute Respiratory Distress Syndrome (ARDS)Phase 2NCT06701682
JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort A: Vilobelimab
A Phase 2 study testing Cohort A: vilobelimab in people with Acute Respiratory Distress Syndrome (ARDS) and ARDS, run by PPD Development, LP at 41 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome (ARDS), ARDS, ARDS (Acute Respiratory Distress Syndrome)
- What is being tested?
- Cohort A: vilobelimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 41 sitesUnited States
- Study dates
- 21 Jun 2025to Sep 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
41 sites in 1 country. Contact the study team or a site near you to ask about taking part.
41 sites in 1 country
United States41 sites, 40 recruiting
- Recruiting
University of Michigan Hospital
Ann Arbor, Michigan, 48109-5000
- Not yet recruiting
University of Alabama Hospital
Birmingham, Alabama, 35233-1932
- Recruiting
St. Luke's Boise Medical Center
Boise, Idaho, 83712-6241
- Not yet recruiting
Tufts Medical Center
Boston, Massachusetts, 02111
- Recruiting
Nova Clinical Research
Bradenton, Florida, 34209-4617
- Recruiting
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805-0001
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-0001
- Recruiting
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425-8908
- Not yet recruiting
University of Virginia Health System
Charlottesville, Virginia, 22908-0816
- Not yet recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106-1716
- Not yet recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
- Recruiting
Denver Health Hospital and Authority
Denver, Colorado, 80204-4532
- Recruiting
Henry Ford Health Hospital
Detroit, Michigan, 48202-2608
- Recruiting
Durham VA Medical Center
Durham, North Carolina, 27705-3875
- Not yet recruiting
Duke Lung Transplant Clinic - Clinic 2F/2G - PPDS
Durham, North Carolina, 27710-4000
- Not yet recruiting
Northshore University Healthsystem Research Institute
Evanston, Illinois, 60201-1700
- Recruiting
Baylor All Saints Medical Center
Fort Worth, Texas, 76104-4110
- Recruiting
Community Regional Medical Center
Fresno, California, 93721-1324
- Recruiting
North Florida / South Georgia Veterans Health System
Gainesville, Florida, 32608-1135
- Not yet recruiting
Baylor St Luke's Medical Center
Houston, Texas, 77030-4202
- Not yet recruiting
Houston Methodist Hospital
Houston, Texas, 77030
- Recruiting
Long Beach Memorial Medical Center
Long Beach, California, 90806-1701
- Recruiting
Intermountain Medical Center
Murray, Utah, 84107-5701
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-0004
- Recruiting
Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901-1928
- Not yet recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065-6007
- Not yet recruiting
Weill Cornell Medical College
New York, New York, 10065-8722
- Recruiting
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104-3609
- Recruiting
University of California Irvine Medical Center
Orange, California, 92868-3201
- Recruiting
OSF Saint Francis Medical Center-
Peoria, Illinois, 61637-0001
- Recruiting
Oregon Health and Science University
Portland, Oregon, 97239-3011
- Withdrawn
Renown Institute for Heart & Vascular Health
Reno, Nevada, 89502-1576
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905-0001
- Recruiting
University of California Davis Medical Center - Pulmonary Medicine
Sacramento, California, 95816-4300
- Recruiting
Sarasota Memorial Hospital
Sarasota, Florida, 34239
- Recruiting
Swedish Medical Center
Seattle, Washington, 98122-4379
- Recruiting
Stanford Medical Center
Stanford, California, 94305-2200
- Recruiting
Montefiore Hospital - Moses Campus
The Bronx, New York, 10467
- Recruiting
Mercy Health - St. Vincent Medical Center
Toledo, Ohio, 43608-2603
- Not yet recruiting
Westchester Medical Center
Valhalla, New York, 10595-1530
- Recruiting
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010-3017
About this study
Official title: Phase 2 Clinical Platform Trial Investigating Multiple Therapeutic Options for the Treatment of Hospitalized Patients With Acute Respiratory Distress Syndrome (ARDS)
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.
Read the 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. This record only includes information relevant to the vilobelimab cohort.
- Conditions
- Acute Respiratory Distress Syndrome (ARDS), ARDS, ARDS (Acute Respiratory Distress Syndrome), Acute Respiratory Distress Syndrome
- Being tested
- Cohort A: vilobelimab, Cohort A: placebo
- Keywords
- BARDA, JUST BREATHE, ARDS, Acute Respiratory Distress Syndrome, Acute Respiratory Failure
- Medical subject headings
- Respiratory Distress Syndrome, Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cohort A: vilobelimabDrug
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: placeboDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: vilobelimab | Experimental | Not described Receives: Drug: Cohort A: vilobelimab |
| Cohort A: placebo | Placebo comparator | Not described Receives: Drug: Cohort A: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality (ACM) rate at Day 28
Measured: Day 28
Secondary outcomes (19)
ACM at Day 60 and Day 90
Measured: Day 60 and Day 90
ACM+ at Day 28, Day 60, and Day 90
ACM+ composite score will be constructed by combining ACM and participant-relevant, infection-related Adverse Events (AE) and Serious Adverse Events (SAEs) from the MedDRA toxic/septic shock standardized MedDRA queries (SMQ).
Measured: Time Frame: Day 28, Day 60, and Day 90
Improvements in oxygenation measured as change from baseline in PaO2/FiO2 ratio up to and including Day 28 (or discharge, whichever is earlier)
Measured: Up to and including Day 28 or until Discharge (whichever is earlier)
Incidence of new invasive mechanical ventilation use during the study up to and including Day 28
Measured: Up to and including Day 28
Ventilator-free days up to and including Day 28
Measured: Up to and including Day 28
Proportion of participants alive and free of mechanical ventilation at Days 28, 60, and 90
Measured: Days 28, 60, and 90
Time to recover gas exchange to a PaO2/FiO2 ≥ 300 measured on 2 consecutive days during the first 28 days after informed consent
Measured: Up to and including Day 28
Extracorporeal Membrane Oxygenation (ECMO) free days up to and including Day 28
Measured: up to and including Day 28
Incidence of participants with new ECMO use during the study up to and including Day 28.
Measured: up to and including Day 28
Proportion of participants alive and free of ECMO at Days 28, 60, and 90
Measured: Days 28, 60, and 90
Proportion of participants achieving a ≥2-point improvement from baseline in the World Health Organization (WHO) 8-levels ordinal scale (from 0-8)
Measured: While Hospitalized (up to 90 days)
Time to an improvement of one category and two categories from baseline using the WHO 8-levels ordinal scale (from 0-8) at Days 28, 60, and 90 (while hospitalized)
Measured: While Hospitalized (up to 90 days)
Mean change in the WHO 8-levels ordinal scale from baseline through Day 90 (while hospitalized)
Measured: While Hospitalized (up to 90 days)
Proportion of participants who improve clinical status as measured by the Karnofsky scale
The Karnofsky scale is used to assess the general condition of the patient. Scores range from 0 to 100 with higher scores indicating better functional ability.
Measured: Post hospitalization through Day 90
Days of hospitalization up to and including Day 28
Measured: up to and including Day 28
Days of ICU stay up to and including Day 28
Measured: up to and including Day 28
Change in Short Form Health Survey (SF-12) from hospital discharge to Day 60 and to Day 90
The SF-12 is a self-reported outcome measure composed by 12 items which examine eight dimensions of physical and mental health. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
Measured: from hospital discharge to Day 60 and to Day 90
Change in St. George's Respiratory Questionnaire (SGRQ) from hospital discharge to Day 60 and to Day 90
The SGRQ comprises of 50 items and consists of two parts. The first part pertains to symptoms and the second pertains to functional status as well as social and psychological impact of disease. Overall scores range between 0 and 100 with higher scores indicating more limitations.
Measured: From hospital discharge to Day 60 and to Day 90
Incidence and severity of adverse events (AEs) /adverse event of special interest (AESI) / serious adverse event (SAEs)
Measured: Through Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start21 Jun 2025
- Primary completionJul 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress Syndrome (ARDS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PPD Development, LP
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority, InflaRx GmbH, Edesa Biotech Inc., Genentech, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06701682
- Sponsor's protocol ID
- BP-ARDS-P2-001 (vilobelimab)
- Other IDs
- 75A50124C00001
- Status last verified
- Jun 2026
- First submitted
- 20 Nov 2024
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Clinical Platform Trial Investigating Multiple Therapeutic Options for the Treatment of Hospitalized Patients With Acute Respiratory Distress Syndrome (ARDS)
- ClinicalTrials.gov ID
- NCT06701682
- Acronym / sponsor ID
- BP-ARDS-P2-001 (vilobelimab)
- Conditions
- Acute Respiratory Distress Syndrome (ARDS), ARDS, ARDS (Acute Respiratory Distress Syndrome), Acute Respiratory Distress Syndrome
- Keywords
- BARDA, JUST BREATHE, ARDS, Acute Respiratory Distress Syndrome, Acute Respiratory Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- PPD Development, LPIndustry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority, InflaRx GmbH, Edesa Biotech Inc., Genentech, Inc.
- Study start
- 21 Jun 2025 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 22 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A: vilobelimab | Experimental | Drug: Cohort A: vilobelimab |
| Cohort A: placebo | Placebo comparator | Drug: Cohort A: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cohort A: vilobelimabAdministered 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: vilobelimab |
| Cohort A: placeboAdministered 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 A: placebo |
Primary outcome
All-cause mortality (ACM) rate at Day 28
Time frame: Day 28
19 secondary outcomes
ACM at Day 60 and Day 90
Time frame: Day 60 and Day 90
ACM+ at Day 28, Day 60, and Day 90
Time frame: Time Frame: Day 28, Day 60, and Day 90
Improvements in oxygenation measured as change from baseline in PaO2/FiO2 ratio up to and including Day 28 (or discharge, whichever is earlier)
Time frame: Up to and including Day 28 or until Discharge (whichever is earlier)
Incidence of new invasive mechanical ventilation use during the study up to and including Day 28
Time frame: Up to and including Day 28
Ventilator-free days up to and including Day 28
Time frame: Up to and including Day 28
Proportion of participants alive and free of mechanical ventilation at Days 28, 60, and 90
Time frame: Days 28, 60, and 90
Time to recover gas exchange to a PaO2/FiO2 ≥ 300 measured on 2 consecutive days during the first 28 days after informed consent
Time frame: Up to and including Day 28
Extracorporeal Membrane Oxygenation (ECMO) free days up to and including Day 28
Time frame: up to and including Day 28
Incidence of participants with new ECMO use during the study up to and including Day 28.
Time frame: up to and including Day 28
Proportion of participants alive and free of ECMO at Days 28, 60, and 90
Time frame: Days 28, 60, and 90
Proportion of participants achieving a ≥2-point improvement from baseline in the World Health Organization (WHO) 8-levels ordinal scale (from 0-8)
Time frame: While Hospitalized (up to 90 days)
Time to an improvement of one category and two categories from baseline using the WHO 8-levels ordinal scale (from 0-8) at Days 28, 60, and 90 (while hospitalized)
Time frame: While Hospitalized (up to 90 days)
Mean change in the WHO 8-levels ordinal scale from baseline through Day 90 (while hospitalized)
Time frame: While Hospitalized (up to 90 days)
Proportion of participants who improve clinical status as measured by the Karnofsky scale
Time frame: Post hospitalization through Day 90
Days of hospitalization up to and including Day 28
Time frame: up to and including Day 28
Days of ICU stay up to and including Day 28
Time frame: up to and including Day 28
Change in Short Form Health Survey (SF-12) from hospital discharge to Day 60 and to Day 90
Time frame: from hospital discharge to Day 60 and to Day 90
Change in St. George's Respiratory Questionnaire (SGRQ) from hospital discharge to Day 60 and to Day 90
Time frame: From hospital discharge to Day 60 and to Day 90
Incidence and severity of adverse events (AEs) /adverse event of special interest (AESI) / serious adverse event (SAEs)
Time frame: Through Day 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
41 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cohort A: vilobelimab in people with Acute Respiratory Distress Syndrome (ARDS) and ARDS, run by PPD Development, LP at 41 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Just Breathe Trial Team (Please email, crgjustbreathealerts.sm@thermofisher.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (ACM) rate at Day 28 (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.