Paridiprubart for Acute Respiratory Distress Syndrome

Recruiting at 27 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called paridiprubart for individuals hospitalized with Acute Respiratory Distress Syndrome (ARDS), a condition where the lungs can't supply enough oxygen to the body's organs. The trial aims to determine if paridiprubart is safe and effective compared to a placebo (a harmless pill with no effect). Participants will be randomly assigned to receive either the actual treatment or the placebo without knowing which one they receive. The trial seeks participants with moderate to severe ARDS who have not had allergic reactions to the treatment ingredients. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

Is there any evidence suggesting that paridiprubart is likely to be safe for humans?

Research has shown that paridiprubart has been tested in people with acute respiratory distress syndrome (ARDS). One study found that it lowered the risk of death within 28 days, indicating its potential effectiveness. While the Phase 2 trial is ongoing, earlier research in a more advanced phase showed that paridiprubart was generally well-tolerated. A data safety monitoring board closely monitors the treatment to track and manage any side effects. This suggests that paridiprubart may be safe for treating ARDS, although more information from the ongoing trial will provide further insights. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Paridiprubart is unique because it offers a new approach to treating Acute Respiratory Distress Syndrome (ARDS) by targeting specific pathways involved in inflammation and lung injury that current treatments don't address. Most treatments for ARDS, like mechanical ventilation and supportive care, focus on managing symptoms rather than tackling the underlying causes. Researchers are excited about Paridiprubart because it could potentially reduce inflammation more effectively, leading to quicker recovery times and better overall outcomes for patients. Its novel mechanism of action could represent a significant advancement in how we manage this serious condition.

What evidence suggests that paridiprubart might be an effective treatment for ARDS?

Studies have shown promising results for paridiprubart in treating Acute Respiratory Distress Syndrome (ARDS). In earlier research, patients who received paridiprubart had a 39% lower risk of death compared to those who received a placebo. Another study found that this treatment reduced the death rate from 59% to 46% after 60 days. In this trial, participants will receive either paridiprubart or a placebo. These findings suggest that paridiprubart may help people with ARDS live longer. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrialsarena.com clinicaltrialsarena.com/news/edesa-reports-phase-iii-results-ards/

Edesa Biotech reports positive Phase III results for ARDS ... Participants who received paridiprubart combined with standard of care (SOC) showed a 39% lower risk of death, compared to 52% with placebo, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06701669

Study Details | NCT06701669 | JUST BREATHE, ... This is a Phase 2 multicenter, randomized, double-blinded, placebo-controlled study that will evaluate the safety and efficacy of host-directed therapeutics ...

3. fiercebiotech.com fiercebiotech.com/biotech/edesa-posts-survival-data-phase-3-respiratory-failure-trial

Edesa claims survival win for phase 3 respiratory failure trial Edesa shared data from its truncated phase 3 respiratory failure trial, linking the anti-TLR4 antibody to improvements in survival and ...

4. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT06701669

UCSF Acute Respiratory Distress Syndrome Trial → JUST ... This is a Phase 2 multicenter, randomized, double-blinded, placebo-controlled study that will evaluate the safety and efficacy of host-directed therapeutics ...

5. trial.medpath.com trial.medpath.com/news/59c0db47444569e4/edesa-biotech-s-paridiprubart-shows-25-mortality-reduction-in-phase-3-ards-trial

Edesa Biotech's Paridiprubart Shows 25% Mortality Reduction ... The survival benefit proved durable at 60 days, with paridiprubart-treated patients showing a 46% mortality rate compared to 59% for placebo, ...

6. biospace.com biospace.com/press-releases/edesa-biotech-reports-positive-results-in-phase-3-respiratory-study

Edesa Biotech Reports Positive Results in Phase 3 ... The company's most advanced Respiratory drug candidate is EB05 (paridiprubart), which is being evaluated in a U.S. government-funded platform ...

7. edesabiotech.com edesabiotech.com/wp-content/uploads/2024/03/Paridriprubart-Background-March2024.pdf

Paridiprubart Background Paridiprubart for ARDS. Page 8. Edesa Biotech - Paridiprubart Background v. Acute Respiratory Distress Syndrome (ARDS) ... data safety monitoring board (DSMB).