JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort A: Vilobelimab
Purpose
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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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: - No additional exclusion criteria beyond the exclusion criteria specified in the Master Protocol NCT06703073.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
- Masking Description
- 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.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Cohort A: vilobelimab |
|
|
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Placebo Comparator Cohort A: placebo |
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Recruiting Locations
Fresno, California 93721-1324
Long Beach, California 90806-1701
Orange, California 92868-3201
Sacramento, California 95816-4300
Denver, Colorado 80204-4532
Washington D.C., District of Columbia 20010-3017
Bradenton, Florida 34209-4617
Gainesville, Florida 32608-1135
Sarasota, Florida 34239
Boise, Idaho 83712-6241
Peoria, Illinois 61637-0001
Burlington, Massachusetts 01805-0001
Ann Arbor, Michigan 48109-5000
Detroit, Michigan 48202-2608
Rochester, Minnesota 55905-0001
New Brunswick, New Jersey 08901-1928
The Bronx, New York 10467
Chapel Hill, North Carolina 27599-0001
Durham, North Carolina 27705-3875
Toledo, Ohio 43608-2603
Oklahoma City, Oklahoma 73104-3609
Portland, Oregon 97239-3011
Charleston, South Carolina 29425-8908
Nashville, Tennessee 37232-0004
Fort Worth, Texas 76104-4110
Murray, Utah 84107-5701
Seattle, Washington 98122-4379
More Details
- NCT ID
- NCT06701682
- Status
- Recruiting
- Sponsor
- PPD Development, LP
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.