Pre-Bronchiolitis Obliterans SyndromePhase 3NCT05654922
Study to Evaluate ARINA-1 in the Prevention of Bronchiolitis Obliterans Progression in Participants With Bilateral Lung Transplant
A Phase 3 study testing ARINA-1 in people with Pre-Bronchiolitis Obliterans Syndrome, run by Renovion, Inc. at 22 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pre-Bronchiolitis Obliterans Syndrome
- What is being tested?
- ARINA-1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 22 sitesUnited States
- Study dates
- 10 Apr 2023to Aug 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Bilateral lung transplant >12 months from the time of Visit 1 / Randomization
- Age 18-75 years old at the time of consent
- Routinely followed at enrolling site
- Willing and able to comply with visit schedule and at-home requirements
- 10-24% decrease in FEV1 from the post-transplant baseline within the last 12 months.
- Capable of giving informed consent
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- On a stable maintenance regimen of azithromycin for >4 weeks prior to the Screening Visit
- On a stable 2-agent or 3-agent immunosuppression regimen that includes a steroid, a calcineurin inhibitor (CNI), and, optionally, a cell cycle inhibitor (e.g., mycophenolate, azathioprine) >4 weeks prior to Screening
- If a woman of childbearing potential (WOCBP), must agree to use a reliable method of birth control for the entire duration of the study.
Who cannot join
- Positive urine pregnancy test at screening and baseline visit
- Diagnosis of active congestive heart failure or symptomatic coronary artery disease > grade 3 based on the New York Heart Association Functional Classification (NYHA) criteria
- Restrictive allograft syndrome (RAS) defined by radiographic interstitial or alveolar opacities on chest X-ray or CT scan that are consistent with RAS
- Have advanced BOS, defined by >24% decrease in FEV1 in post-transplant baseline
- A diagnosis of probable antibody-mediated rejection (AMR) <12 months prior to the baseline visit
- Donor-specific antibodies (DSA) identified <6 months prior to the baseline visit. *The presence of DSA >6 months from the baseline visit is acceptable for enrollment into the study.
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- Unresolved diffuse alveolar damage
- Receiving mechanical ventilation
- Chronic kidney disease stage IV or higher, including on dialysis
- Initiating a new maintenance therapy or changing immunosuppression maintenance therapy (e.g., changing tacrolimus to cyclosporine) <30 days prior to the baseline visit.
- Have initiated or changed mTOR maintenance therapy <3 months prior to Clinic Visit 1 (mTOR use for >3 months is allowed)
- Initiating or changing antibiotic (including azithromycin), antiviral, or antifungal therapy <14 days prior to the baseline visit.
- Use of alemtuzumab <6 months prior to the baseline visit
- Use of anti-thymocyte therapies (e.g., anti-thymocyte globulin) or photopheresis <90 days prior to the Screening Visit. Prior use of Trikafta (elexacaftor, ivacaftor, and tezacaftor is allowed as long as the participant has been on stable dose for >90 days prior to the Screening Visit.
- Initiating a multivitamin or other supplement (inhaled, oral, or IV) containing vitamin C, glutathione, or N-acetylcysteine <90 days prior to the baseline visit
- Significant unstable comorbidities, in the opinion of the site investigator
- Allery or previous adverse reaction to azithromycin
- A diagnosis of dynamic collapse / tracheobrochomalacia <90 days of the baseline visit.
- Subjects currently participating in, or who have participated in an interventional (drug or device) clinical study <30 days of the baseline visit.
- Have been diagnosed with ARAD within 6 weeks of the Screening Visit.
- Have used belatacept <6 months prior to Clinic Visit 1
- Have had an initial treatment of bronchial stents or cryotherapy within 12 months of the Screening Visit, or had bronchial stents removed within the last 3 months of the Screening Visit.
Trial locations and contacts
22 sites in 1 country. Contact the study team or a site near you to ask about taking part.
22 sites in 1 country
United States22 sites, 20 recruiting
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Christian Merlo, MD
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29452
Tim Whelan, MD
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Marie Budev, DO
- Recruiting
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43221
Justin Rosenheck, DO
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 45390
Vaidehi Kaza, MD
- Recruiting
Baylor Scott and White Research Institute
Dallas, Texas, 75246
Samir Kumar, MD
- Recruiting
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Shambhu Aryal, MD
- Recruiting
Baylor St. Luke's Medical Center
Houston, Texas, 77030
Prangthip Charoenpong, MD, MPH
- Recruiting
Houston Methodist Hospital
Houston, Texas, 77030
Howard Huang, MD
- Recruiting
University of Iowa Hospital
Iowa City, Iowa, 52242
Julia Klesney-Tait, MD, PhD
- Recruiting
University of California Los Angeles School of Medicine
Los Angeles, California, 90095
Sam Weigt, MD
- Recruiting
Loyola University Medical Center
Maywood, Illinois, 60153
Daniel Dilling, MD
- Withdrawn
University of Minnesota Medical School
Minneapolis, Minnesota, 55455
- Not yet recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Ciara Shaver, MD, PhD
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
Selim Arcasoy, MD
- Recruiting
Advent Health
Orlando, Florida, 32803
Suresh Manickavel, MD
- Recruiting
Temple University Hospital
Philadelphia, Pennsylvania, 19122
Rachel Criner, MD
- Withdrawn
Dignity Health - St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
- Not yet recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Yuka Yuka Furuya, MD
- Recruiting
University of California San Diego Health
San Diego, California, 92103
Kamyar Afshar, MD
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Chad Witt, MD
- Recruiting
University of South Florida
Tampa, Florida, 33606
Satish Chandrashekaran, MD
About this study
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
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.
Read more
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
- Pre-Bronchiolitis Obliterans Syndrome
- Being tested
- ARINA-1, Standard of care only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARINA-1Drug
ARINA-1 (88 mg/mL ascorbic acid, ASC; 150 mg/mL reduced glutathione, GSH)
Standard of care onlyOther
Standard 3-therapy immunosuppression regimen and azithromycin
| Study group | Role | What they receive |
|---|---|---|
| ARINA-1 plus standard of care | Experimental | ARINA-1 (88 mg/mL ascorbic acid, ASC; 150 mg/mL reduced glutathione, GSH); fixed dose, 4 mL solution inhaled twice daily via nebulization plus standard 3-therapy immunosuppression regimen and azithromycin Receives: Drug: ARINA-1 |
| Standard of care only | Other | Standard 3-therapy immunosuppression regimen and azithromycin Receives: Other: Standard of care only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change from baseline in FEV1 (%ΔFEV1)
Week 24 (mL) - Baseline (mL) = ΔFEV1 (mL) ΔFEV1 (mL) / Baseline (mL) x 100 = %ΔFEV1
Measured: 24 weeks
Secondary outcomes (11)
Percentage change from baseline of Forced Expiratory Volume in one second (FEV1)
Week 48 (mL) - Baseline (mL) = ΔFEV1 (mL) ΔFEV1 (mL) / Baseline (mL) x 100 = %ΔFEV1
Measured: 48 weeks
Percentage change from baseline of Forced Vital Capacity (FVC)
Measured: 24 weeks
Percentage change from baseline of FVC
Measured: 48 weeks
Percentage change from baseline of FEF25-75%
Measured: 24 weeks
Percentage change from baseline of FEF25-75%
Measured: 48 weeks
Number of participants in each arm with augmented immunosuppression
number
Measured: 24 weeks
Number of participants in each arm with augmented immunosuppression
Measured: 48 weeks
Time to initiation of augmented immunosuppression
Length of time to when participant requires a change in their immunosuppression regimen
Measured: over the duration of the 48 week trial
Change from baseline in Saint George's Respiratory Questionnaire total score
quality of life questionnaire, total score of 0 to 100, higher score = more limitations
Measured: 24 weeks
Change from baseline in Saint George's Respiratory Questionnaire total score
quality of life questionnaire, total score of 0 to 100, higher score = more limitations
Measured: 48 weeks
Proportion of participants requiring the use of antimicrobial agents to treat a pulmonary infection
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start10 Apr 2023
- Primary completionFeb 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-Bronchiolitis Obliterans SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renovion, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tim Whelan, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05654922
- Sponsor's protocol ID
- RVN-001
- Status last verified
- Aug 2026
- First submitted
- 8 Dec 2022
- Last updated
- 5 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05654922
- Acronym / sponsor ID
- RVN-001
- Conditions
- Pre-Bronchiolitis Obliterans Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Renovion, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 16 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARINA-1 plus standard of care | Experimental | Drug: ARINA-1ARINA-1 (88 mg/mL ascorbic acid, ASC; 150 mg/mL reduced glutathione, GSH); fixed dose, 4 mL solution inhaled twice daily via nebulization plus standard 3-therapy immunosuppression regimen and azithromycin |
| Standard of care only | Other | Other: Standard of care onlyStandard 3-therapy immunosuppression regimen and azithromycin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Bilateral lung transplant >12 months from the time of Visit 1 / Randomization
- Age 18-75 years old at the time of consent
- Routinely followed at enrolling site
- Willing and able to comply with visit schedule and at-home requirements
- 10-24% decrease in FEV1 from the post-transplant baseline within the last 12 months.
Key exclusion criteria (22 listed)
- Positive urine pregnancy test at screening and baseline visit
- Diagnosis of active congestive heart failure or symptomatic coronary artery disease > grade 3 based on the New York Heart Association Functional Classification (NYHA) criteria
- Restrictive allograft syndrome (RAS) defined by radiographic interstitial or alveolar opacities on chest X-ray or CT scan that are consistent with RAS
- Have advanced BOS, defined by >24% decrease in FEV1 in post-transplant baseline
- A diagnosis of probable antibody-mediated rejection (AMR) <12 months prior to the baseline visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARINA-1ARINA-1 (88 mg/mL ascorbic acid, ASC; 150 mg/mL reduced glutathione, GSH) | Drug | ARINA-1 plus standard of care |
| Standard of care onlyStandard 3-therapy immunosuppression regimen and azithromycin | Other | Standard of care only |
Primary outcome
Percentage change from baseline in FEV1 (%ΔFEV1)
Time frame: 24 weeks
Week 24 (mL) - Baseline (mL) = ΔFEV1 (mL) ΔFEV1 (mL) / Baseline (mL) x 100 = %ΔFEV1
11 secondary outcomes
Percentage change from baseline of Forced Expiratory Volume in one second (FEV1)
Time frame: 48 weeks
Percentage change from baseline of Forced Vital Capacity (FVC)
Time frame: 24 weeks
Percentage change from baseline of FVC
Time frame: 48 weeks
Percentage change from baseline of FEF25-75%
Time frame: 24 weeks
Percentage change from baseline of FEF25-75%
Time frame: 48 weeks
Number of participants in each arm with augmented immunosuppression
Time frame: 24 weeks
Number of participants in each arm with augmented immunosuppression
Time frame: 48 weeks
Time to initiation of augmented immunosuppression
Time frame: over the duration of the 48 week trial
Change from baseline in Saint George's Respiratory Questionnaire total score
Time frame: 24 weeks
Change from baseline in Saint George's Respiratory Questionnaire total score
Time frame: 48 weeks
Proportion of participants requiring the use of antimicrobial agents to treat a pulmonary infection
Time frame: 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tim Whelan, MD principal investigator
Medical University of South Carolina
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ARINA-1 in people with Pre-Bronchiolitis Obliterans Syndrome, run by Renovion, Inc. at 22 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carolyn Durham, PhD (919-240-7034, info@renovion.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change from baseline in FEV1 (%ΔFEV1) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.