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NCT Number: NCT06701669

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

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.

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Key information

Conditions

Acute Respiratory Distress Syndrome (ARDS) ARDS ARDS (Acute Respiratory Distress Syndrome) Acute Lung Injury Acute Respiratory Distress Syndrome Lung Diseases Lung Injury Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Alabama Hospital, Birmingham, Alabama, United States

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About this study

This is a master protocol for a Phase 2 platform clinical trial to evaluate host-directed therapeutic candidates (i.e., investigational product, IP) for the treatment of hospitalized participants diagnosed with ARDS. The safety and efficacy of each IP will be studied within its own cohort (IP versus Placebo). All patients will continue to receive standard treatments for ARDS as per the investigator. An individual participant will complete the study in approximately 90 days. The study will include a screening period (<24 hours from providing informed consent to treatment), in-hospital treatment period with IP/placebo starting on Day 1 through discharge from the hospital, and a follow-up period after discharge from the hospital through the end of study (Day 90 + 2 weeks). Outcome data will be assembled for each patient over time (such as ventilatory status, oxygenation, and survival). Functional status using the WHO Ordinal scale and Karnofsky scale will be collected. Resource utilization will be calculated (length of stay in a critical care setting, days intubated, and survival).

All participants will undergo a series of physical exams, laboratory assessments/biomarker collections, ECG, Chest X-ray or CT scan, and questionnaires through Day 90. Exploratory biomarkers will be evaluated over time to facilitate clinical learning. This record only includes information relevant to the paridiprubart cohort.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The following inclusion criteria are in addition to the exclusion criteria specified in the Master Protocol NCT06703073:

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

Exclusion criteria

The following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol NCT06703073.

-Participant has a known allergy or known hypersensitivity to paridiprubart or its excipients, including polysorbate 80

Treatment and study plan

Cohort B: paridiprubart

Drug

Administered as a single IV dose of 15 mg/kg up to maximum of 1440 mg on Day 1

Cohort B: placebo

Drug

Administered as a single IV dose of placebo on Day 1

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

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

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

  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

  5. Ventilator-free days up to and including Day 28

    Time frame: Up to and including Day 28

  6. Proportion of participants alive and free of mechanical ventilation at Days 28, 60, and 90

    Time frame: Days 28, 60, and 90

  7. Time to recover gas exchange to a PaO2/FiO2 ≥ 300 measured on 2 consecutive days during the first 28 days after informed consent

    Time frame: Up to and including Day 28

  8. Extracorporeal Membrane Oxygenation (ECMO) free days up to and including Day 28

    Time frame: up to and including Day 28

  9. Incidence of participants with new ECMO use during the study up to and including Day 28

    Time frame: up to and including Day 28

  10. Proportion of participants alive and free of ECMO at Days 28, 60, and 90

    Time frame: Days 28, 60, and 90

  11. Proportion of participants achieving a ≥2-point improvement from baseline in the World Health Organization (WHO) 8-levels ordinal scale (from 0-8)

    Time frame: While Hospitalized (up to 90 days)

  12. Time to an improvement of one category and two categories from baseline using the WHO 8-levels ordinal scale (from 0-8) at Days 28, 60, and 90 (while hospitalized)

    Time frame: While Hospitalized (up to 90 days)

  13. Mean change in the WHO 8-levels ordinal scale from baseline through Day 90 (while hospitalized)

    Time frame: While Hospitalized (up to 90 days)

  14. Proportion of participants who improve clinical status as measured by the Karnofsky scale

    Time frame: Post hospitalization through Day 90

    The Karnofsky scale is used to assess the general condition of the patient. Scores range from 0 to 100 with higher scores indicating better functional ability.

  15. Days of hospitalization up to and including Day 28

    Time frame: up to and including Day 28

  16. Days of ICU stay up to and including Day 28

    Time frame: up to and including Day 28

  17. Change in Short Form Health Survey (SF-12) from hospital discharge to Day 60 and to Day 90

    Time frame: from hospital discharge to Day 60 and to Day 90

    The SF-12 is a self-reported outcome measure composed by 12 items which examine eight dimensions of physical and mental health. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.

  18. Change in St. George's Respiratory Questionnaire (SGRQ) from hospital discharge to Day 60 and to Day 90

    Time frame: From hospital discharge to Day 60 and to Day 90

    The SGRQ comprises of 50 items and consists of two parts. The first part pertains to symptoms and the second pertains to functional status as well as social and psychological impact of disease. Overall scores range between 0 and 100 with higher scores indicating more limitations.

  19. Incidence and severity of adverse events (AEs) /adverse event of special interest (AESI) / serious adverse event (SAEs)

    Time frame: Through Day 90

Study contacts

Contact information is provided by the study sponsor or research team.

Just Breathe Trial Team

CONTACT

[email protected]

Please email

Sponsors and collaborators

Lead sponsor

PPD Development, LP

Industry

Collaborators

  • Biomedical Advanced Research and Development Authority
  • Edesa Biotech Inc.
  • Genentech, Inc.
  • InflaRx GmbH

Registry information

Official study title

Phase 2 Clinical Platform Trial Investigating Multiple Therapeutic Options for the Treatment of Hospitalized Patients With Acute Respiratory Distress Syndrome (ARDS)

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Nov 22, 2024
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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