Inhaled ARO-RAGE for allergen-triggered mild asthma

A Randomized, Double-blind, Placebo-controlled Phase 2a Study of ARO-RAGE Inhalation Solution to Assess Efficacy on Small Airway Dysfunction in Allergen-induced Mild Asthma

This trial will test whether inhaled ARO-RAGE can reduce the late asthmatic response after an allergen challenge in people with mild allergic asthma.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Arrowhead Pharmaceuticals (industry)
• Locations: 1 site (Vancouver, British Columbia)
• Trial ID: NCT07241546 on ClinicalTrials.gov

What this trial studies

This Phase 2 study gives inhaled ARO-RAGE or matching placebo to participants with mild atopic asthma and then exposes them to a controlled inhaled allergen challenge. The main outcome is the late asthmatic response (LAR) measured by changes in lung function in the hours following allergen exposure. Eligible participants must have FEV1 ≥70% predicted, a positive skin prick test, and be off medications that interfere with inhaled challenge testing. The study is conducted at a single research site in Vancouver, British Columbia.

Who should consider this trial

Good fit: Ideal candidates are people with clinically stable mild atopic asthma, FEV1 ≥70% predicted, and a confirmed allergy on skin prick testing who can perform lung function testing.

Not a fit: People with moderate-to-severe asthma, other important pulmonary diseases, chronic use of corticosteroids or immunosuppressants, or who cannot undergo inhaled or methacholine challenges are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, inhaled ARO-RAGE could reduce allergen-triggered late asthma symptoms and airway inflammation in people with mild atopic asthma.

How similar studies have performed: Targeting RAGE with an inhaled oligonucleotide is a relatively novel approach and clinical evidence for inhaled RAGE-targeting therapies is currently limited.

Eligibility criteria

Inclusion Criteria:

* Clinically stable, mild atopic asthma (FEV1 ≥70% predicted)
* Established allergy confirmed by positive skin prick test at screening
* Willing and able to perform lung function tests and other study-related procedures
* Participants of childbearing potential must consent to use a method of highly-effective contraception in addition to a condom during the study and for at least 90 days following the end of study or last investigational product administration, whichever is later

Exclusion Criteria:

* Concomitant diagnosis of a clinically important pulmonary disease other than asthma
* Use of corticosteroids, immunosuppressives, or anti-inflammatory medications that interfere with inhaled challenges or inflammation, or chronic use of any other medication for treatment of allergic asthma
* History or current medical condition contraindicating methacholine challenge

Note: Additional inclusion/exclusion criteria may apply per protocol.

Where this trial is running

Vancouver, British Columbia

• Research Site 1 — Vancouver, British Columbia, Canada (RECRUITING)

Study contacts

• Study coordinator: Medical Monitor

Conditions: Asthma