100 Participants Needed

ARINA-1 for Bronchiolitis Obliterans Syndrome

Recruiting at 23 trial locations
SC
CD
WA
Overseen ByWill Anderson
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Renovion, Inc.
Must be taking: Azithromycin, Immunosuppressants
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial requires participants to be on a stable maintenance regimen of azithromycin and a stable 3-agent immunosuppression regimen for more than 4 weeks before the screening. If you are currently using an mTOR inhibitor, azathioprine, or have recently changed certain medications, you may need to adjust your current medications to participate.

What data supports the effectiveness of the drug ARINA-1 for Bronchiolitis Obliterans Syndrome?

The research on RV568, a component of ARINA-1, shows it has strong anti-inflammatory effects in conditions like COPD (a lung disease), which might suggest potential benefits for similar lung conditions like Bronchiolitis Obliterans Syndrome.12345

What makes the drug ARINA-1 unique for treating Bronchiolitis Obliterans Syndrome?

ARINA-1 is unique because it may target the interferon (IFN) pathway, which is often deficient in conditions like asthma and COPD, potentially offering a novel approach to managing Bronchiolitis Obliterans Syndrome by enhancing antiviral responses.678910

What is the purpose of this trial?

This trial is testing ARINA-1, a new treatment added to usual care, for lung transplant patients at risk of a serious lung condition called BOS. The goal is to see if ARINA-1 can prevent the condition from getting worse and improve patients' quality of life. The trial involves periodic health monitoring to track progress and any side effects.

Research Team

RH

Ramsey Hachem, MD

Principal Investigator

Barnes-Jewish Hospital / Washington University

Eligibility Criteria

This trial is for adults aged 18-75 who've had a bilateral lung transplant over a year ago and are experiencing a decline in lung function. They must be on stable medications, including azithromycin and immunosuppressants, willing to follow the study schedule, and women of childbearing age must use birth control. Exclusions include recent use of certain therapies or supplements, unresolved lung damage, severe heart or kidney disease, participation in other trials recently, and specific treatments within set timeframes.

Inclusion Criteria

I had a lung transplant more than a year ago.
I agree to use birth control during the study.
I am able to understand and agree to the study's procedures and risks.
See 5 more

Exclusion Criteria

I was diagnosed with ARAD less than 6 weeks ago.
I have severe heart failure or coronary artery disease.
I started taking supplements with vitamin C, glutathione, or N-acetylcysteine less than 90 days ago.
See 19 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive ARINA-1 plus Standard of Care or Standard of Care alone

48 weeks
Clinic visits at randomization (day 1), weeks 4, 12, 18, 24, 32, 40, and 48; telehealth visit on day 2; phone calls during weeks 5, 8, 36, and 44

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • ARINA-1
Trial Overview The trial tests ARINA-1 combined with standard care against standard care alone to see if it can prevent worsening of bronchiolitis obliterans syndrome (BOS) after lung transplants. It also looks at whether ARINA-1 helps maintain quality of life by reducing the need for increased immunosuppression therapy.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Standard of care onlyExperimental Treatment1 Intervention
Standard 3-therapy immunosuppression regimen and azithromycin
Group II: ARINA-1 plus standard of careExperimental Treatment1 Intervention
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

ARINA-1 is already approved in United States for the following indications:

🇺🇸
Approved in United States as ARINA-1 for:
  • Prevention of bronchiolitis obliterans syndrome (BOS) progression in bilateral lung transplant patients (Fast Track designation)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Renovion, Inc.

Lead Sponsor

Trials
3
Recruited
140+

Findings from Research

RV568, a new anti-inflammatory drug, showed strong anti-inflammatory effects in cell and animal models related to COPD, often outperforming traditional corticosteroids.
In a 14-day trial with COPD patients, inhaled RV568 improved lung function and reduced harmful substances in sputum, while being well-tolerated with similar adverse events to placebo.
RV568, a narrow-spectrum kinase inhibitor with p38 MAPK-α and -γ selectivity, suppresses COPD inflammation.Charron, CE., Russell, P., Ito, K., et al.[2021]
QVA149, a dual bronchodilator for COPD, showed a good safety profile over 52 weeks, with similar rates of adverse events compared to placebo and most events being mild to moderate.
The treatment provided rapid and sustained bronchodilation, significantly improving lung function in patients with moderate-to-severe COPD, with a lower discontinuation rate in the QVA149 group compared to placebo.
Safety and efficacy of dual bronchodilation with QVA149 in COPD patients: the ENLIGHTEN study.Dahl, R., Chapman, KR., Rudolf, M., et al.[2022]
In a study involving 934 patients with moderate-to-severe COPD, QVA149 was found to be non-inferior to the combination of tiotropium and formoterol in improving health-related quality of life, as measured by the St George's Respiratory Questionnaire-COPD.
QVA149 also demonstrated significant improvements in lung function, with greater increases in pre-dose FEV1 and forced vital capacity compared to the other treatment, while the safety profile was similar for both medications.
Efficacy and safety of once-daily QVA149 compared with the free combination of once-daily tiotropium plus twice-daily formoterol in patients with moderate-to-severe COPD (QUANTIFY): a randomised, non-inferiority study.Buhl, R., Gessner, C., Schuermann, W., et al.[2022]

References

RV568, a narrow-spectrum kinase inhibitor with p38 MAPK-α and -γ selectivity, suppresses COPD inflammation. [2021]
Safety and efficacy of dual bronchodilation with QVA149 in COPD patients: the ENLIGHTEN study. [2022]
Efficacy and safety of once-daily QVA149 compared with the free combination of once-daily tiotropium plus twice-daily formoterol in patients with moderate-to-severe COPD (QUANTIFY): a randomised, non-inferiority study. [2022]
Safety and efficacy of dual therapy with GSK233705 and salmeterol versus monotherapy with salmeterol, tiotropium, or placebo in a crossover pilot study in partially reversible COPD patients. [2021]
Navafenterol (AZD8871) in healthy volunteers: safety, tolerability and pharmacokinetics of multiple ascending doses of this novel inhaled, long-acting, dual-pharmacology bronchodilator, in two phase I, randomised, single-blind, placebo-controlled studies. [2022]
Methylated Vnn1 at promoter regions induces asthma occurrence via the PI3K/Akt/NFκB-mediated inflammation in IUGR mice. [2023]
Rhinovirus C15 Attenuates Relaxation and cAMP Production in Human Airways and Smooth Muscle. [2023]
Rhinovirus 16-induced IFN-α and IFN-β are deficient in bronchoalveolar lavage cells in asthmatic patients. [2021]
Interferon response of the cystic fibrosis bronchial epithelium to major and minor group rhinovirus infection. [2022]
TLR7/8 regulates type I and type III interferon signalling in rhinovirus 1b-induced allergic asthma. [2022]
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