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

Last updated: August 16, 2024
Sponsor: Renovion, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Respiratory Syncytial Virus (Rsv) Infection

Bronchitis (Pediatric)

Treatment

ARINA-1

Standard of care only

Clinical Study ID

NCT05654922
RVN-001
  • Ages 18-75
  • All Genders

Study Summary

The goal of this clinical trial is to compare ARINA-1 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Bilateral lung transplant >12 months from the time of Visit 1 / Randomization

  2. Age 18-75 years old at the time of consent

  3. Routinely followed at enrolling site

  4. Willing and able to comply with visit schedule and at-home requirements

  5. 10-24% decrease in FEV1 from the post-transplant baseline within the last 12 months.

  6. Capable of giving informed consent

  7. On a stable maintenance regimen of azithromycin for >4 weeks prior to the ScreeningVisit

  8. On a stable 3-agent immunosuppression regimen that includes a steroid, a calcineurininhibitor (CNI), and cell cycle inhibitor (e.g., mycophenolate, azathioprine) >4weeks prior to Screening

  9. If a woman of childbearing potential (WOCBP), must agree to use a reliable method ofbirth control for the entire duration of the study.

Exclusion

Exclusion Criteria:

  1. Positive urine pregnancy test at screening and baseline visit

  2. Diagnosis of active congestive heart failure or symptomatic coronary artery disease > grade 3 based on the New York Heart Association Functional Classification (NYHA)criteria

  3. Restrictive allograft syndrome (RAS) defined by radiographic interstitial oralveolar opacities on chest X-ray or CT scan that are consistent with RAS

  4. Have advanced BOS, defined by >24% decrease in FEV1 in post-transplant baseline

  5. A diagnosis of probable antibody-mediated rejection (AMR) <12 months prior to thebaseline visit

  6. 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 enrollmentinto the study.

  7. Unresolved diffuse alveolar damage

  8. Receiving mechanical ventilation

  9. Chronic kidney disease stage IV or higher, including on dialysis

  10. Initiating a new maintenance therapy or changing immunosuppression maintenancetherapy (e.g., changing tacrolimus to cyclosporine) <14 days prior to the baselinevisit.

  11. Currently using an mTOR inhibitor or azathioprine

  12. Initiating or changing antibiotic (including azithromycin), antiviral, or antifungaltherapy <14 days prior to the baseline visit.

  13. Use of alemtuzumab <6 months prior to the baseline visit

  14. Use of anti-thymocyte therapies (e.g., anti-thymocyte globulin) or photopheresis <90days 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 >90days prior to the Screening Visit.

  15. Initiating a multivitamin or other supplement (inhaled, oral, or IV) containingvitamin C, glutathione, or N-acetylcysteine <90 days prior to the baseline visit

  16. Significant unstable comorbidities, in the opinion of the site investigator

  17. Allery or previous adverse reaction to azithromycin

  18. A diagnosis of dynamic collapse / tracheobrochomalacia <90 days of the baselinevisit.

  19. Subjects currently participating in, or who have participated in an interventional (drug or device) clinical study <30 days of the baseline visit.

  20. Have been diagnosed with ARAD within 6 weeks of the Screening Visit.

  21. Have used belatacept <6 months prior to Clinic Visit 1

  22. Have had bronchial stents or cryotherapy within 12 months of the Screening Visit

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: ARINA-1
Phase: 3
Study Start date:
April 10, 2023
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • Dignity Health - St. Joseph's Hospital and Medical Center

    Phoenix, Arizona 85013
    United States

    Active - Recruiting

  • University of California Log Angeles School of Medicine

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • University of California Los Angeles (UCLA)

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • University of California Los Angeles School of Medicine

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • University of California San Diego Health

    San Diego, California 92103
    United States

    Active - Recruiting

  • University of California at San Diego

    San Diego, California 92103
    United States

    Site Not Available

  • Advent Health

    Orlando, Florida 32803
    United States

    Active - Recruiting

  • Adventist Health

    Orlando, Florida 32803
    United States

    Active - Recruiting

  • University of South Florida

    Tampa, Florida 33606
    United States

    Active - Recruiting

  • University of South Florida - Tampa General Hospital

    Tampa, Florida 33606
    United States

    Active - Recruiting

  • University of Iowa Hospital

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • Johns Hopkins Hospital

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Active - Recruiting

  • University of Minnesota Medical School

    Minneapolis, Minnesota 55455
    United States

    Active - Recruiting

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Columbia University

    New York, New York 10032
    United States

    Active - Recruiting

  • Columbia University Irving Medical Center

    New York, New York 10032
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Ohio State University Wexner Medical Center

    Columbus, Ohio 43221
    United States

    Active - Recruiting

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio 43221
    United States

    Active - Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina 29452
    United States

    Active - Recruiting

  • Baylor Scott and White Research Institute

    Dallas, Texas 75246
    United States

    Active - Recruiting

  • University of Texas Southwestern Medical Center

    Dallas, Texas 45390
    United States

    Active - Recruiting

  • Houston Methodist Hospital

    Houston, Texas 77030
    United States

    Active - Recruiting

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