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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
PPD Development, LP
Study ID
NCT06701682
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cohort A: vilobelimab — 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 — 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)

Study Details

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.

Key Dates

Start date
Jun 21, 2025
Status verified
Apr 2026
Primary completion
Jul 31, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A: vilobelimab
  • Placebo Comparator: Cohort A: placebo

Primary Outcome Measure

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

Central Contacts

Locations (40)

FacilityCityStateZIPSite coordinators
University of Alabama HospitalBirminghamAlabama35233-1932-
Community Regional Medical CenterFresnoCalifornia93721-1324-
Long Beach Memorial Medical CenterLong BeachCalifornia90806-1701-
University of California Irvine Medical CenterOrangeCalifornia92868-3201-
University of California Davis Medical Center - Pulmonary MedicineSacramentoCalifornia95816-4300-
Denver Health Hospital and AuthorityDenverColorado80204-4532-
MedStar Washington Hospital CenterWashington D.C.District of Columbia20010-3017-
Nova Clinical ResearchBradentonFlorida34209-4617-
North Florida / South Georgia Veterans Health SystemGainesvilleFlorida32608-1135-
Sarasota Memorial HospitalSarasotaFlorida34239-
St. Luke's Boise Medical CenterBoiseIdaho83712-6241-
Northshore University Healthsystem Research InstituteEvanstonIllinois60201-1700-
OSF Saint Francis Medical Center-PeoriaIllinois61637-0001-
Tufts Medical CenterBostonMassachusetts02111-
Lahey Hospital and Medical CenterBurlingtonMassachusetts01805-0001-
University of Michigan HospitalAnn ArborMichigan48109-5000-
Henry Ford Health HospitalDetroitMichigan48202-2608-
Mayo ClinicRochesterMinnesota55905-0001-
Renown Institute for Heart & Vascular HealthRenoNevada89502-1576-
Robert Wood Johnson Medical SchoolNew BrunswickNew Jersey08901-1928-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-6007-
Weill Cornell Medical CollegeNew YorkNew York10065-8722-
Montefiore Hospital - Moses CampusThe BronxNew York10467-
Westchester Medical CenterValhallaNew York10595-1530-
University of North Carolina at Chapel HillChapel HillNorth Carolina27599-0001-
Duke Lung Transplant Clinic - Clinic 2F/2G - PPDSDurhamNorth Carolina27710-4000-
Durham VA Medical CenterDurhamNorth Carolina27705-3875-
Cleveland ClinicClevelandOhio44195-
University Hospitals Cleveland Medical CenterClevelandOhio44106-1716-
Mercy Health - St. Vincent Medical CenterToledoOhio43608-2603-
The University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104-3609-
Oregon Health and Science UniversityPortlandOregon97239-3011-
Medical University of South Carolina (MUSC)CharlestonSouth Carolina29425-8908-
Vanderbilt University Medical CenterNashvilleTennessee37232-0004-
Baylor All Saints Medical CenterFort WorthTexas76104-4110-
Baylor St Luke's Medical CenterHoustonTexas77030-4202-
Houston Methodist HospitalHoustonTexas77030-
Intermountain Medical CenterMurrayUtah84107-5701-
University of Virginia Health SystemCharlottesvilleVirginia22908-0816-
Swedish Medical CenterSeattleWashington98122-4379-

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University of Alabama Hospital· Birmingham, ALCommunity Regional Medical Center· Fresno, CALong Beach Memorial Medical Center· Long Beach, CAUniversity of California Irvine Medical Center· Orange, CAUniversity of California Davis Medical Center - Pulmonary Medicine· Sacramento, CADenver Health Hospital and Authority· Denver, CO

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