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
1 other identifier
interventional
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 asthma
Started Mar 2026
Typical duration for phase_2 asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2025
CompletedFirst Posted
Study publicly available on registry
November 21, 2025
CompletedStudy Start
First participant enrolled
March 30, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
April 13, 2026
November 1, 2025
1.7 years
November 17, 2025
April 8, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change from Baseline Over Time in Maximum Area of Reactance
Baseline through Day 58
Secondary Outcomes (3)
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)
Study Arms (2)
ARO-RAGE
EXPERIMENTALARO-RAGE inhalation
Placebo
PLACEBO COMPARATORNormal saline (0.9%)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Research Site 1
Vancouver, British Columbia, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2025
First Posted
November 21, 2025
Study Start
March 30, 2026
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
April 1, 2028
Last Updated
April 13, 2026
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share