NCT06701682 JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort A: Vilobelimab
| NCT ID | NCT06701682 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | PPD Development, LP |
| Condition | Acute Respiratory Distress Syndrome (ARDS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-06-21 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 200 participants in total. It began in 2025-06-21 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06701682 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Respiratory Distress Syndrome (ARDS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06701682 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06701682 currently recruiting?
Yes, NCT06701682 is actively recruiting participants. Contact the research team at crgjustbreathealerts.sm@thermofisher.com for enrollment information.
Where is the NCT06701682 trial being conducted?
This trial is being conducted at Birmingham, United States, Fresno, United States, Long Beach, United States, Orange, United States and 11 additional locations.
Who is sponsoring the NCT06701682 clinical trial?
NCT06701682 is sponsored by PPD Development, LP. The trial plans to enroll 200 participants.