Paridiprubart for Acute Respiratory Distress Syndrome

Recruiting at 3 trial locations

Overseen By Just Breathe Trial Team

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: PPD DEVELOPMENT, LP

Disqualifiers: Allergy to paridiprubart, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: In-hospital stay

200 Participants Needed

Trial Summary

What is the purpose of 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 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.

Eligibility Criteria

This trial is for hospitalized adults with Acute Respiratory Distress Syndrome (ARDS). Participants must meet additional criteria not specified here. People who have certain conditions that would exclude them from the study are not eligible.

Inclusion Criteria

This statement is incomplete to provide a summary.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

<24 hours

Treatment

Participants receive either paridiprubart or placebo starting on Day 1 through discharge from the hospital

In-hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment through the end of study

Approximately 14 weeks

Treatment Details

Interventions

• Paridiprubart

Trial Overview The trial is testing a new treatment called paridiprubart against a placebo in people with ARDS. It's a Phase 2 study, where patients are randomly assigned to either the drug or placebo without knowing which one they're getting.

Participant Groups

Group I: Cohort B: paridiprubart Experimental Treatment 1 Intervention

Group II: Cohort B: placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

PPD DEVELOPMENT, LP

Lead Sponsor

Trials

167

Recruited

38,000+

David Simmons

PPD DEVELOPMENT, LP

Chief Executive Officer since 2012

BSc in Applied Science from Georgia Institute of Technology

Martina Flammer

PPD DEVELOPMENT, LP

Chief Medical Officer since 2024

MD

PPD Development, LP

Lead Sponsor

Biomedical Advanced Research and Development Authority BARDA (Funder)

Collaborator

Trials

4

Recruited

1,200+

Edesa Biotech Inc.

Industry Sponsor

Trials

6

Recruited

2,100+

Genentech, Inc.

Industry Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

InflaRx GmbH

Industry Sponsor

Trials

16

Recruited

2,300+

Founded

2007

Headquarters

Jena, Germany

Known For

Inflammation research

Top Products

Gohibic (vilobelimab)

Biomedical Advanced Research and Development Authority

Collaborator

Trials

108

Recruited

574,000+