Vilobelimab 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: Others

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called vilobelimab for individuals with Acute Respiratory Distress Syndrome (ARDS), a severe lung condition that makes breathing very difficult. The trial aims to determine if vilobelimab is safe and effective in reducing ARDS symptoms compared to a placebo (a substance with no active medication). Participants will be randomly assigned to receive either vilobelimab or the placebo. This trial suits those currently hospitalized with moderate to severe ARDS. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

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

Earlier studies have shown vilobelimab to be safe. Research suggests it helped lower the death rate in critically ill COVID-19 patients on ventilators, with few serious side effects. The studies found some differences based on location, but overall, patients tolerated vilobelimab well. While testing continues for ARDS, these findings suggest vilobelimab may be safe for people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ARDS?

Vilobelimab is unique because it targets a specific part of the immune system, known as complement factor C5a, which plays a key role in inflammation and tissue damage in Acute Respiratory Distress Syndrome (ARDS). Unlike standard treatments for ARDS, which generally include supportive care like mechanical ventilation and corticosteroids to reduce inflammation, Vilobelimab offers a more targeted approach by directly inhibiting this inflammatory pathway. Researchers are excited about Vilobelimab because this targeted action has the potential to reduce lung injury and improve outcomes more effectively than current therapies.

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

Research has shown that vilobelimab can reduce deaths in patients with severe breathing problems. One study found that vilobelimab lowered the 28-day death rate in patients with acute respiratory distress syndrome (ARDS) from 59.5% to 40%. This indicates that fewer people died within 28 days when they received this treatment. In this trial, one group of participants will receive vilobelimab, while another group will receive a placebo. Vilobelimab works by blocking a part of the immune system that can cause damage during serious lung conditions. These findings suggest vilobelimab could be a promising option for ARDS patients. ^{1 4 6 7 8}

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 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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06701682

Study Details | NCT06701682 | 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12039489/

An evaluation of vilobelimab (anti-C5a) as a cost-effective ... Vilobelimab provides a cost-effective option to treat ICU patients with severe COVID-19 receiving IMV compared to SOC, at well below the commonly accepted ...

3. journal.chestnet.org journal.chestnet.org/article/S0012-3692(23)02273-0/fulltext

VILOBELIMAB TREATMENT EFFECT ON 28-DAY ALL ... Overall, Vilo statistically reduced all-cause 28-day mortality in severe ARDS patients (Vilo 40% vs Plc 59.5%: HR 0.55; 95% CI:0.30-0.98, P= ...

4. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT06701682

JUST BREATHE, Breathing Life Into Innovative Therapies ... This is a Phase 2 multicenter, randomized, double-blinded, placebo-controlled study that will evaluate the safety and efficacy of host-directed therapeutics ...

5. inflarx.de inflarx.de/Home/Investors/Press-Releases/Press-Release~2025-05-InflaRx-Announces-Outcome-of-Interim-Analysis-for-Vilobelimab-Phase-3-Trial-in-Pyoderma-Gangrenosum~.html

Press Release The results showed that vilobelimab treatment improved survival with a relative reduction in 28-day all-cause mortality of 23.9% compared to ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12010313/

Regional comparison of efficacy and safety for vilobelimab ... Vilobelimab demonstrated a favourable safety profile and reduced mortality in critically ill, intubated COVID-19 patients, with regional variations influencing ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2949788425000905

Vilobelimab in Combination with Tocilizumab, Levilimab or ... This post-hoc analysis evaluated vilobelimab's effect on survival and safety in a subgroup of intubated COVID-19 ARDS patients treated ...

8. ema.europa.eu ema.europa.eu/en/medicines/human/EPAR/gohibic

Gohibic | European Medicines Agency (EMA) Gohibic is a medicine used to treat acute respiratory distress syndrome (ARDS) ... data on the efficacy and safety of the medicine under ...