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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 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. The trial reports 20 study locations across 14 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05654922
The ClinicalTrials.gov registry entry for NCT05654922 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Renovion, which has 2 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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.
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