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RecruitingNCT07241546Updated Oct 1, 2026

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

A Phase 2 interventional study of ARO-RAGE and Placebo in Asthma, sponsored by Arrowhead Pharmaceuticals. Recruiting at 6 sites in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-01.

Sponsored by Arrowhead Pharmaceuticals · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2026; still recruiting 6 months later.
Updated Oct 1, 20261 site addedGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Asthma

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03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's planned enrollment of 36 is below the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Arrowhead Pharmaceuticals is the lead sponsor of 50 studies on the registry; 10 are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 12 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
36 participants (estimated)

Study arms

  • Experimental
    ARO-RAGE

    ARO-RAGE inhalation

    Drug: ARO-RAGE

  • Placebo comparator
    Placebo

    Normal saline (0.9%)

    Drug: Placebo

Interventions

  • DrugARO-RAGE

    Inhalation of nebulized solution

  • DrugPlacebo

    Calculated volume to match active treatment by inhalation of nebulized solution

06

What researchers measure

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)

07

Study locations

6 of 6 sites recruiting
  • Research Site 1
    Vancouver, British Columbia V5Z 1M9, Canada
    Recruiting
  • Research Site 2
    Calgary, T2N 4N1, Canada
    Recruiting
  • Research Site 3
    Edmonton, T6G 2G3, Canada
    Recruiting
  • Research Site 5
    Hamilton, L8N 3Z5, Canada
    Recruiting
  • Research Site 6
    Québec, G1V-4G5, Canada
    Recruiting
  • Research Site 4
    Saskatoon, S7M 2W2, Canada
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Sites
1 site added
Show site
  • Research Site 6 · Québec, Canada
Oct 1, 2026
Show all 1 update
  1. Oct 1, 2026
    1 site added
    Show site
    • Research Site 6 · Québec, Canada
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07241546
Lead sponsor
Arrowhead Pharmaceuticals
Responsible party
Sponsor
First posted
Nov 21, 2025
Start date
Mar 30, 2026
Primary completion
Dec 2027 (estimated)
Completion
Apr 2028 (estimated)
Last update
Oct 1, 2026

Study contacts

Medical Monitor
Contact
ARORAGE-2001@arrowheadpharma.com
626-304-3400

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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