drugset / Trial / NCT06701682
JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort A: Vilobelimab
Phase 2
Recruiting
200 enrolled
PPD Development, LP
Biomedical Advanced Research and Development Authority · collabEdesa Biotech Inc. · collabGenentech, Inc. · collabInflaRx GmbH · collab
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2025-06-21
- Primary completion
- 2028-07
- Completion
- 2028-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | vilobelimab | Monoclonal antibody | 800 mg | Intravenous |