Study of Inhaled ARO-RAGE in Allergen-induced 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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07241546

Enrollment

Registered

2025-11-21

Start date

2026-03-30

Completion date

2028-04-01

Last updated

2026-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Brief summary

The purpose of this study is to evaluate the impact of inhaled ARO-RAGE on the late asthmatic response (LAR) following an inhaled allergen challenge in participants with mild atopic asthma.

Interventions

DRUGARO-RAGE

Inhalation of nebulized solution

DRUGPlacebo

Calculated volume to match active treatment by inhalation of nebulized solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
Change from Baseline Over Time in Maximum Area of Reactance	Baseline through Day 58

Secondary

Measure	Time frame
Change from Baseline Over Time in Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve	Baseline through Day 58
Change from Baseline Over Time in Maximum Change in Small Airway Reactance	Baseline through Day 58
Number of Participants with Treatment-Emergent Adverse Events	Up to Day 113 (End of Study)

Countries

Canada

Contacts

CONTACTMedical Monitor

ARORAGE-2001@arrowheadpharma.com626-304-3400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 24, 2026