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

PPD DEVELOPMENT, LP

Status and phase: Not yet enrolling; Phase 2

Conditions: ARDS (Acute Respiratory Distress Syndrome); Acute Respiratory Distress Syndrome; Acute Respiratory Distress Syndrome (ARDS); ARDS

Treatments: Drug: Cohort B: placebo; Drug: Cohort B: paridiprubart

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT06701669

75A50124C00001 (Other Grant/Funding Number)

BP-ARDS-P2-001 (paridiprubart)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

200 participants in 2 patient groups, including a placebo group

Cohort B: paridiprubart

Experimental group

Treatment:

Drug: Cohort B: paridiprubart

Cohort B: placebo

Placebo Comparator group

Treatment:

Drug: Cohort B: placebo