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NCT05654922 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate ARINA-1 in the Prevention of Bronchiolitis Obliterans Progression in Participants With Bilateral Lung Transplant
A Phase 3 study of Pre-Bronchiolitis Obliterans Syndrome, sponsored by Renovion.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 100
- Enrollment target
- 20
- Study locations
NCT05654922: Recruiting Phase 3 study of Pre-Bronchiolitis Obliterans Syndrome, sponsored by Renovion.
NCT05654922 is a Phase 3 study of Pre-Bronchiolitis Obliterans Syndrome that is actively recruiting participants, run by Renovion. The registered enrollment target is 100 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05654922, a Phase 3 study of Pre-Bronchiolitis Obliterans Syndrome, is actively recruiting participants, sponsored by Renovion.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 100 participants
- Enrollment target
- 20
- Study locations
Study Summary
The goal of this Phase 3 clinical trial is to compare ARINA-1 (a nebulized immunomodulatory agent) plus Standard of Care vs Standard of Care alone. The main question it aims to answer are: * Evaluate the effectiveness of ARINA-1 in preventing bronchiolitis obliterans syndrome (BOS) progression in participants with a bilateral lung transplant * To evaluate the effectiveness of ARINA-1 on improving quality of life decline and preventing or delaying the use of augmented immunosuppression in participants with pre-BOS relative to SOC. Participants will have clinic visits at screening, randomization (day 1) and weeks 4, 12, 18, and 24. After week 24, participants will have clinic visits at weeks 32, 40, and 48. Participants will also have a telehealth visit on day 2 and phone calls to assess adverse events (AEs), serious adverse events (SAEs), and review patient education will occur during weeks 5, 8, 36, and 44.
Primary Outcome
Week 24 (mL) - Baseline (mL) = ΔFEV1 (mL) ΔFEV1 (mL) / Baseline (mL) x 100 = %ΔFEV1
Conditions Studied
Interventions
- DRUG ARINA-1
- OTHER Standard of care only
Study Locations (20)
Texas
- University of Texas Southwestern Medical Center - Dallas
- Baylor Scott and White Research Institute - Dallas
- Baylor St. Luke's Medical Center - Houston
- Houston Methodist Hospital - Houston
California
- University of California Los Angeles School of Medicine - Los Angeles
- University of California San Diego Health - San Diego
Florida
- Advent Health - Orlando
- University of South Florida - Tampa
Ohio
- Cleveland Clinic - Cleveland
- The Ohio State University Wexner Medical Center - Columbus
Arizona
- Dignity Health - St. Joseph's Hospital and Medical Center - Phoenix
Illinois
- Loyola University Medical Center - Maywood
Iowa
- University of Iowa Hospital - Iowa City
Maryland
- Johns Hopkins Hospital - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2023-04-10 |
| Est. Completion | 2026-11 |
| Phase | Phase 3 |
What NCT05654922 shows while recruiting
NCT05654922 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Pre-Bronchiolitis Obliterans Syndrome appearing as the primary indexed condition, and to 2 interventions - of which ARINA-1 is the first listed.
NCT05654922 names 20 study sites across 14 states, led by Texas, California, Florida.
Frequently Asked Questions
What is clinical trial NCT05654922 about?
NCT05654922 is a clinical study titled "Study to Evaluate ARINA-1 in the Prevention of Bronchiolitis Obliterans Progression in Participants With Bilateral Lung Transplant". The goal of this Phase 3 clinical trial is to compare ARINA-1 (a nebulized immunomodulatory agent) plus Standard of Care vs Standard of Care alone. The main question it aims to answer are: * Evaluate the effectiveness of ARINA-1 in preventing bronchiolitis obliterans syndrome (BOS) progression in p...
What is the current status of trial NCT05654922?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 100 participants. The study started on 2023-04-10. Estimated completion is 2026-11.
What conditions does trial NCT05654922 study?
This clinical trial studies the following conditions: Pre-Bronchiolitis Obliterans Syndrome.
What interventions are being tested in trial NCT05654922?
The interventions under investigation include: ARINA-1 (DRUG), Standard of care only (OTHER).
Who is sponsoring clinical trial NCT05654922?
This trial is sponsored by Renovion, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05654922 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Illinois, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05654922's enrollment target sits among peer trials
100 1682nd of 2000 higher than 288 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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