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Evaluating vilobelimab for treating Acute Respiratory Distress Syndrome

Phase 2 Clinical Platform Trial Investigating Multiple Therapeutic Options for the Treatment of Hospitalized Patients With Acute Respiratory Distress Syndrome (ARDS)

Phase 2 Interventional PPD Development, LP · NCT06701682

This study is testing if vilobelimab can help hospitalized adults with Acute Respiratory Distress Syndrome feel better and improve their chances of recovery compared to a placebo.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment200 (estimated)
Ages18 Years and up
SexAll
SponsorPPD Development, LP Industry-sponsored
Drugs / interventionsvilobelimab
Locations40 sites (Birmingham, Alabama and 39 other locations)
Trial IDNCT06701682 on ClinicalTrials.gov

What this trial studies

This Phase 2 multicenter, randomized, double-blinded, placebo-controlled study aims to assess the safety and efficacy of vilobelimab, a host-directed therapeutic, in hospitalized adults diagnosed with Acute Respiratory Distress Syndrome (ARDS). Participants will be randomly assigned to receive either vilobelimab or a placebo while continuing standard ARDS treatments. The study will monitor various outcomes, including ventilatory status, oxygenation, and survival, over a period of approximately 90 days. Data will be collected through physical exams, laboratory assessments, and questionnaires to evaluate the treatment's impact on patient health.

Who should consider this trial

Good fit: Ideal candidates are hospitalized adults diagnosed with moderate to severe ARDS.

Not a fit: Patients with mild ARDS or those not meeting the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for patients suffering from ARDS.

How similar studies have performed: Other studies have explored host-directed therapies for ARDS, but this specific approach with vilobelimab is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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:

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

Where this trial is running

Birmingham, Alabama and 39 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acute Respiratory Distress SyndromeARDSBARDAJUST BREATHEAcute Respiratory Failure
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.