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

ConditionsAcute Respiratory Distress Syndrome (ARDS)ARDSARDS (Acute Respiratory Distress Syndrome)Acute Respiratory Distress Syndrome
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPPD Development, LP

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

ARDS Severity of moderate or severe based on PaO2/FiO2 or SpO2/FiO2 assessment at the time of randomization

Participant with established cirrhosis and a modified Child-Pugh Score of 12 or greater

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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)

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Cohort A: vilobelimabExperimental treatment 1 intervention
Group B: Cohort A: placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

All-cause mortality (ACM) rate at Day 28

Time frame
Day 28

Secondary outcomes

1

ACM at Day 60 and Day 90

Time frame
Day 60 and Day 90
2

ACM+ at Day 28, Day 60, and Day 90

ACM+ composite score will be constructed by combining ACM and participant-relevant, infection-related Adverse Events (AE) and Serious Adverse Events (SAEs) from the MedDRA toxic/septic shock standardized MedDRA queries (SMQ).

Time frame
Time Frame: Day 28, Day 60, and Day 90
3

Improvements in oxygenation measured as change from baseline in PaO2/FiO2 ratio up to and including Day 28 (or discharge, whichever is earlier)

Time frame
Up to and including Day 28 or until Discharge (whichever is earlier)
4

Incidence of new invasive mechanical ventilation use during the study up to and including Day 28

Time frame
Up to and including Day 28

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

PPD Development, LP

Lead sponsor

Biomedical Advanced Research and Development Authority

Collaborator

InflaRx GmbH

Collaborator

Edesa Biotech Inc.

Collaborator

Genentech, Inc.

Collaborator

Source ClinicalTrials.gov
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