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NCT Number: NCT07241546

Study of Inhaled ARO-RAGE in Allergen-induced Mild Asthma

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.

Recruiting

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site 1, Vancouver, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ARO-RAGE

Drug

Inhalation of nebulized solution

Placebo

Drug

Calculated volume to match active treatment by inhalation of nebulized solution

Primary outcomes

  1. Change from Baseline Over Time in Maximum Area of Reactance

    Time frame: Baseline through Day 58

Secondary outcomes

  1. Change from Baseline Over Time in Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve

    Time frame: Baseline through Day 58

  2. Change from Baseline Over Time in Maximum Change in Small Airway Reactance

    Time frame: Baseline through Day 58

  3. Number of Participants with Treatment-Emergent Adverse Events

    Time frame: Up to Day 113 (End of Study)

Study contacts

Contact information is provided by the study sponsor or research team.

Medical Monitor

CONTACT

[email protected]

626-304-3400

Sponsors and collaborators

Lead sponsor

Arrowhead Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Nov 21, 2025
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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