Study to Evaluate ARINA-1 in the Prevention of Bronchiolitis Obliterans Progression in Participan… (NCT05654922) | Clinical Trial Compass
RecruitingPhase 3
Study to Evaluate ARINA-1 in the Prevention of Bronchiolitis Obliterans Progression in Participants With Bilateral Lung Transplant
United States100 participantsStarted 2023-04-10
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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
✓. 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
Exclusion criteria
✕. 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.