Vilobelimab 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

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

Compensation: Varies

Number of Visits: 1

Duration: In-hospital stay

200 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. Please refer to the Master Protocol NCT06703073 or consult with the trial coordinators for more details.

What data supports the effectiveness of the drug Vilobelimab for treating acute respiratory distress syndrome?

Vilobelimab, a drug that targets a protein called C5a, has been shown to reduce mortality in critically ill COVID-19 patients who were on ventilators, suggesting it may help with severe lung issues like acute respiratory distress syndrome. ^{1 2 3 4 5}

How is the drug vilobelimab unique for treating acute respiratory distress syndrome?

Vilobelimab is unique because it is a monoclonal antibody that specifically targets and blocks C5a, a protein involved in inflammation, which has shown promise in reducing mortality in critically ill COVID-19 patients. This mechanism of action is different from other treatments for acute respiratory distress syndrome, which may not specifically target this pathway. ^{1 2 3 4 5}

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

Inclusion Criteria

My lung condition is moderate or severe, based on oxygen levels.

Exclusion Criteria

No additional exclusion criteria beyond the exclusion criteria specified in the Master Protocol NCT06703073.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

<24 hours

1 visit (in-person)

Treatment

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

In-hospital stay

Daily monitoring (in-person)

Follow-up

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

90 days

Regular assessments (in-person and virtual)

Treatment Details

Interventions

• Vilobelimab

Trial Overview The trial is testing vilobelimab, a host-directed therapy, against a placebo in ARDS patients. It's part of a larger platform trial and involves random assignment to either the drug or placebo in a double-blinded setup.

Participant Groups

Group I: Cohort A: vilobelimab Experimental Treatment 1 Intervention

Group II: Cohort A: 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+

InflaRx GmbH

Industry Sponsor

Trials

16

Recruited

2,300+

Founded

2007

Headquarters

Jena, Germany

Known For

Inflammation research

Top Products

Gohibic (vilobelimab)

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

Biomedical Advanced Research and Development Authority

Collaborator

Trials

108

Recruited

574,000+

Findings from Research

In a phase 3 study involving 368 critically ill COVID-19 patients, vilobelimab significantly reduced C5a levels by 87% by day 8, indicating its efficacy in inhibiting this inflammatory mediator.

The treatment showed no significant immunogenicity, with only one patient developing antidrug antibodies, suggesting that vilobelimab is safe for use in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetic analysis of vilobelimab, anaphylatoxin C5a and antidrug antibodies in PANAMO: a phase 3 study in critically ill, invasively mechanically ventilated COVID-19 patients. Lim, EHT., Vlaar, APJ., de Bruin, S., et al.[2023]

A novel domain antibody targeting the p55 receptor significantly reduced lung injury and edema in mouse models of acid-induced acute respiratory distress syndrome (ARDS), showing protective effects lasting up to 24 hours after a single dose.

The treatment not only improved physiological markers of ARDS but also reduced pulmonary inflammation, suggesting that targeting the p55 receptor could be a promising therapeutic strategy for patients at risk of ARDS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inhibition of TNF Receptor p55 By a Domain Antibody Attenuates the Initial Phase of Acid-Induced Lung Injury in Mice. Wilson, MR., Wakabayashi, K., Bertok, S., et al.[2019]

In a phase 3 trial involving 368 patients on invasive mechanical ventilation due to COVID-19, vilobelimab, an anti-C5a monoclonal antibody, showed a trend towards improved survival, with a 28-day all-cause mortality rate of 32% in the vilobelimab group compared to 42% in the placebo group, suggesting a potential benefit in reducing mortality.

Vilobelimab was associated with a significant reduction in mortality in a predefined analysis without site-stratification (hazard ratio 0.67), indicating that it may be an effective additional therapy for patients with severe COVID-19, although further research is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-C5a antibody (vilobelimab) therapy for critically ill, invasively mechanically ventilated patients with COVID-19 (PANAMO): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial. Vlaar, APJ., Witzenrath, M., van Paassen, P., et al.[2023]

In a small exploratory trial involving 30 patients with severe COVID-19, the monoclonal antibody IFX-1 (vilobelimab) was found to be safe, with no treatment-related deaths and a lower incidence of serious pulmonary embolisms compared to the control group.

While the primary outcome showed no significant difference in oxygenation improvement (PaO2/FiO2) between the IFX-1 group and the control group, there was a trend towards lower mortality in the IFX-1 group (13% vs 27%), suggesting potential benefits that warrant further investigation in larger trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-C5a antibody IFX-1 (vilobelimab) treatment versus best supportive care for patients with severe COVID-19 (PANAMO): an exploratory, open-label, phase 2 randomised controlled trial. Vlaar, APJ., de Bruin, S., Busch, M., et al.[2022]

Vilobelimab (GohibicTM) has received emergency use authorization from the FDA for treating hospitalized adults with COVID-19, specifically when initiated within 48 hours of invasive mechanical ventilation or extracorporeal membrane oxygenation.

In a phase II/III study, vilobelimab significantly reduced the risk of death at both 28 and 60 days for patients on mechanical ventilation compared to those receiving a placebo, highlighting its potential efficacy in severe COVID-19 cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing the use of vilobelimab for the treatment of COVID-19. McCarthy, MW.[2023]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Pharmacokinetic analysis of vilobelimab, anaphylatoxin C5a and antidrug antibodies in PANAMO: a phase 3 study in critically ill, invasively mechanically ventilated COVID-19 patients. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Inhibition of TNF Receptor p55 By a Domain Antibody Attenuates the Initial Phase of Acid-Induced Lung Injury in Mice. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Anti-C5a antibody (vilobelimab) therapy for critically ill, invasively mechanically ventilated patients with COVID-19 (PANAMO): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Anti-C5a antibody IFX-1 (vilobelimab) treatment versus best supportive care for patients with severe COVID-19 (PANAMO): an exploratory, open-label, phase 2 randomised controlled trial. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Optimizing the use of vilobelimab for the treatment of COVID-19. [2023]