Inhaled ARO-RAGE for allergen-triggered mild asthma
Official title: 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
Run by Arrowhead Pharmaceuticals · NCT07241546 · Data updated 2026-11-12
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 | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 36 (estimated) |
| Sponsor | Arrowhead Pharmaceuticals Industry-sponsored |
| Locations | 6 sites (Vancouver, British Columbia and 5 other locations) |
| Status | Recruiting |
| Started | March 30, 2026 |
| Main results expected | December 2027 |
| Study ends | April 2028 |
| Registry record updated | October 1, 2026 |
| Trial ID | NCT07241546 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Targeting RAGE with an inhaled oligonucleotide is a relatively novel approach and clinical evidence for inhaled RAGE-targeting therapies is currently limited.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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Research Site 1
Vancouver, British Columbia, Canada Recruiting -
Research Site 2
Calgary, Canada Recruiting -
Research Site 3
Edmonton, Canada Recruiting -
Research Site 5
Hamilton, Canada Recruiting -
Research Site 6
Québec, Canada Recruiting -
Research Site 4
Saskatoon, Canada Recruiting
Study contacts
- Study coordinator: Medical Monitor
- Email: ARORAGE-2001@arrowheadpharma.com
- Phone: 626-304-3400
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.