NCT05654922招募中3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 42
- 主要终点
- Percentage change from baseline in FEV1 (%ΔFEV1)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
For individuals performing spirometry, every attempt will be made to keep them masked to treatment.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •If a woman of childbearing potential (WOCBP), must agree to use a reliable method of birth control for the entire duration of the study.
排除标准
- •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.
- •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.
研究组 & 干预措施
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
干预措施: ARINA-1 (Drug)
Standard of care only
Other
Standard 3-therapy immunosuppression regimen and azithromycin
干预措施: Standard of care only (Other)
结局指标
主要结局
Percentage change from baseline in FEV1 (%ΔFEV1)
时间窗: 24 weeks
Week 24 (mL) - Baseline (mL) = ΔFEV1 (mL) ΔFEV1 (mL) / Baseline (mL) x 100 = %ΔFEV1
次要结局
- Percentage change from baseline of Forced Expiratory Volume in one second (FEV1)(48 weeks)
- Percentage change from baseline of Forced Vital Capacity (FVC)(24 weeks)
- Percentage change from baseline of FVC(48 weeks)
- Percentage change from baseline of FEF25-75%(48 weeks)
- Number of participants in each arm with augmented immunosuppression(48 weeks)
- Time to initiation of augmented immunosuppression(over the duration of the 48 week trial)
- Change from baseline in Saint George's Respiratory Questionnaire total score(48 weeks)
- Proportion of participants requiring the use of antimicrobial agents to treat a pulmonary infection(48 weeks)
- Percentage change from baseline of FEF25-75%(24 weeks)
- Number of participants in each arm with augmented immunosuppression(24 weeks)
- Change from baseline in Saint George's Respiratory Questionnaire total score(24 weeks)
研究者
研究点 (42)
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