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JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort B: Paridiprubart

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Study sites: 40 to 41
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 1 of 19 entries
    v16
  2. Trial sites expanded: 36 → 40 locationsv15
  3. Study sites: 32 to 36v14
  4. Study sites: 30 to 32v13
  5. Study sites: 28 to 30v12
Show 10 earlier versionsHide 10 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
    v11
  2. Study sites: 16 to 24v10
  3. Study sites: 11 to 16v9
  4. Study sites: 8 to 11v8
  5. Start date: Apr 17, 2025 to Jun 10, 2025
    • Study sites: 4 to 8
    v7
  6. Study sites: 3 to 4v6
  7. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    v5
  8. Start date: Apr 1, 2025 to Apr 17, 2025v4
  9. Start date: Jan 6, 2025 to Apr 1, 2025v3
  10. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 B: Participants will be randomized to receive either a placebo or paridiprubart. This record describes the default procedures and analyses for Cohort B. Please see NCT06703073 for information on the BP-ARDS-P2-001 Master Protocol.
Trial Details
NCT Number NCT06701669
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