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Recruiting Phase 3 Interventional

Study to Evaluate ARINA-1 in the Prevention of Bronchiolitis Obliterans Progression in Participants With Bilateral Lung Transplant

ClinicalTrials.gov ID: NCT05654922

Public ClinicalTrials.gov record NCT05654922. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 6, 2026, 7:43 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3, Open-label, Randomized, Standard of Care-controlled, Parallel Study Arm Study to Demonstrate Efficacy and Safety of ARINA-1 in the Prevention of Bronchiolitis Obliterans Syndrome (BOS) Progression in Participants With a Bilateral Lung Transplant

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05654922
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Renovion, Inc.
Industry
Enrollment
100 participants

Conditions and interventions

Interventions

Drug · Other

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 9, 2023
Primary completion
Jan 31, 2028
Completion
Jul 31, 2028
Last update posted
Aug 4, 2026

2023 – 2028

United States locations

U.S. sites
22
U.S. states
15
U.S. cities
20
Facility City State ZIP Site status
Dignity Health - St. Joseph's Hospital and Medical Center Phoenix Arizona 85013 Withdrawn
University of California Los Angeles School of Medicine Los Angeles California 90095 Recruiting
University of California San Diego Health San Diego California 92103 Recruiting
Advent Health Orlando Florida 32803 Recruiting
University of South Florida Tampa Florida 33606 Recruiting
Loyola University Medical Center Maywood Illinois 60153 Recruiting
University of Iowa Hospital Iowa City Iowa 52242 Recruiting
Johns Hopkins Hospital Baltimore Maryland 21287 Recruiting
University of Minnesota Medical School Minneapolis Minnesota 55455 Withdrawn
Mayo Clinic Rochester Minnesota 55905 Not yet recruiting
Washington University School of Medicine St Louis Missouri 63110 Recruiting
Columbia University Irving Medical Center New York New York 10032 Recruiting
Cleveland Clinic Cleveland Ohio 44195 Recruiting
The Ohio State University Wexner Medical Center Columbus Ohio 43221 Recruiting
Temple University Hospital Philadelphia Pennsylvania 19122 Recruiting
Medical University of South Carolina Charleston South Carolina 29452 Recruiting
Vanderbilt University Medical Center Nashville Tennessee 37232 Not yet recruiting
University of Texas Southwestern Medical Center Dallas Texas 45390 Recruiting
Baylor Scott and White Research Institute Dallas Texas 75246 Recruiting
Baylor St. Luke's Medical Center Houston Texas 77030 Recruiting
Houston Methodist Hospital Houston Texas 77030 Recruiting
Inova Fairfax Hospital Falls Church Virginia 22042 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05654922, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 4, 2026 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05654922 live on ClinicalTrials.gov.

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