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

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Study sites: 40 to 41
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 1 of 19 entries
    v17
  2. Trial sites expanded: 36 → 40 locationsv16
  3. Study sites: 32 to 36v15
  4. Study sites: 30 to 32v14
  5. Study sites: 28 to 30v13
Show 11 earlier versionsHide 11 earlier versions
  1. Primary completion date: Nov 26, 2027 to Jul 2028
    • Study sites: 24 to 28
    • Study completion date: Feb 8, 2028 to Sep 2028
    v12
  2. Study sites: 16 to 24v11
  3. Study sites: 11 to 16v10
  4. Study sites: 4 to 11v9
  5. Start date: Feb 13, 2025 to Jun 21, 2025v8
  6. Study sites: 3 to 4v7
  7. Study sites: 2 to 3v6
  8. Re-verified, no change to tracked fieldsv5
  9. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of Feb 17, 2025 to Feb 13, 2025
    v4
  10. Start date: Dec 27, 2024 to Feb 17, 2025v3
  11. Eligibility criteria revised
    • Secondary endpoints revised (19)
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06701682
Lead Sponsor PPD Development, LP
Collaborators: Biomedical Advanced Research and Development Authority, InflaRx GmbH, Edesa Biotech Inc., Genentech, Inc.
Conditions
(from sponsor)		 Acute Respiratory Distress Syndrome (ARDS), ARDS, ARDS (Acute Respiratory Distress Syndrome), Acute Respiratory Distress Syndrome
Related terms Acute Lung Injury, Respiratory Distress Syndrome
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov