36 Participants NeededMy employer runs this trial

ARO-RAGE for Asthma

Recruiting at 4 trial locations
MM
Overseen ByMedical Monitor
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new inhaled treatment called ARO-RAGE to evaluate its effectiveness for individuals with mild atopic asthma, particularly after allergen exposure. The goal is to determine if ARO-RAGE can manage the late asthmatic response, which occurs when asthma symptoms flare up hours after allergen exposure. Participants will receive either ARO-RAGE or a placebo (a treatment with no active drug) to compare effects. Ideal candidates for this trial have been diagnosed with mild, stable asthma and have confirmed allergies from a skin test. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

Yes, you will need to stop taking corticosteroids, immunosuppressives, anti-inflammatory medications, or any chronic medication for allergic asthma, as they can interfere with the study.

Is there any evidence suggesting that ARO-RAGE is likely to be safe for humans?

Previous studies have shown ARO-RAGE to be safe. Patients using ARO-RAGE experienced no negative effects on lung function, and the medicine primarily remained in the lungs, where it is needed, with minimal distribution to other body parts. Healthy volunteers also tolerated ARO-RAGE well, with no serious side effects reported. Overall, research suggests that the treatment is safe and well-tolerated.12345

Why do researchers think this study treatment might be promising for asthma?

Most treatments for asthma focus on reducing inflammation and opening airways, often using inhaled corticosteroids or bronchodilators. But ARO-RAGE works differently, targeting the receptor for advanced glycation end-products (RAGE) to potentially reduce inflammation in the lungs. This new mechanism of action could offer an alternative for patients who do not respond well to standard therapies. Researchers are excited because ARO-RAGE is administered through inhalation, directly targeting the lungs, which might lead to more efficient and rapid symptom relief compared to systemic treatments.

What evidence suggests that ARO-RAGE might be an effective treatment for asthma?

Research has shown that ARO-RAGE could be a helpful treatment for asthma. In studies, patients experienced up to an 88% drop in a blood marker called sRAGE, linked to inflammation in asthma. This decrease suggests that ARO-RAGE might help reduce lung inflammation associated with asthma. Additionally, the treatment significantly reduced certain genes in lung tissues, indicating it may effectively lessen asthma symptoms. These early results are promising for people with mild to moderate asthma. Participants in this trial will receive either ARO-RAGE inhalation or a placebo to further evaluate its effectiveness.12456

Are You a Good Fit for This Trial?

This trial is for people with mild, stable allergic asthma confirmed by a skin test. Participants must have good lung function, be able to do breathing tests, and use effective birth control if needed. People with other serious lung diseases or using certain asthma medications can't join.

Inclusion Criteria

Established allergy confirmed by positive skin prick test at screening
My mild asthma is stable and my lung function is at least 70% of normal.
Willing and able to perform lung function tests and other study-related procedures
See 1 more

Exclusion Criteria

I have another serious lung disease besides asthma.
I have a condition that makes methacholine testing unsafe for me.
I regularly use medications that affect my asthma or immune system.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive inhaled ARO-RAGE or placebo to assess efficacy on small airway dysfunction

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • ARO-RAGE

Trial Overview

The study compares inhaled ARO-RAGE to a placebo in people with mild allergic asthma. It looks at how well ARO-RAGE works in reducing late asthmatic reactions after exposure to an allergen.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: ARO-RAGEExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Arrowhead Pharmaceuticals

Lead Sponsor

Trials
45
Recruited
6,200+

Citations

Arrowhead Pharmaceuticals Presents New Clinical Data ...

After two doses of ARO-RAGE in patients with mild to moderate asthma, serum sRAGE was reduced up to 88% with a mean maximum reduction up to 77%; Serum sRAGE was ...

Inhaled ARO-RAGE Is Safe and Well-Tolerated in Mild to ...

Serum sRAGE decreased 88% and BALF sRAGE decreased 94% in healthy volunteers at 4 weeks following 2 doses of ARO-RAGE 184 mg. Minimal changes ...

NCT05276570 | Study of ARO-RAGE in Healthy Subjects ...

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of ARO-RAGE in normal healthy volunteers (NHVs) and in participants ...

A First-in-Human Study of ARO-RAGE, a Novel Inhaled ...

Data cut 05 Apr 2024 from an ongoing study. Background. Multiple Doses of ARO-RAGE Reduced BALF & Serum sRAGE in NHVs and Asthma Patients.

Arrowhead reports interim data from ARO-RAGE study

Arrowhead reports interim data from ARO-RAGE study ... ARO-RAGE demonstrated high levels of gene knockdown to help patients living with asthma.

Late Breaking Abstract - A first-in-human study of ARO-RAGE ...

Conclusion: In healthy volunteers, ARO-RAGE has been safe and well tolerated, and resulted in pulmonary silencing of RAGE expression. Further Phase 1 data from ...