Recruiting
Phase 2

ARO-RAGE

Sponsor:

Arrowhead Pharmaceuticals

Code:

NCT07241546

Conditions

Asthma

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

ARO-RAGE

Placebo

Study Details

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.

Conditions

Asthma

Study ID

NCT07241546

Start date

Mar 30, 2026

Status verified date

Jun, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ARO-RAGE

ARO-RAGE inhalation

placebo comparator: Placebo

Normal saline (0.9%)

Interventions

ARO-RAGE

Inhalation of nebulized solution

Placebo

Calculated volume to match active treatment by inhalation of nebulized solution

Primary outcome measure

  • Change from Baseline Over Time in Maximum Area of Reactance [ Time Frame: Baseline through Day 58 ]

Central Contacts and Locations

Central contacts

Medical Monitor

626-304-3400ARORAGE-2001@arrowheadpharma.com

Locations

Research Site 1

Recruiting

Vancouver, British Columbia, Canada

Research Site 2

Recruiting

Calgary, Canada, T2N 4N1

Research Site 3

Recruiting

Edmonton, Canada, T6G 2G3

Research Site 5

Recruiting

Hamilton, Canada, L8N 3Z5

Research Site 4

Recruiting

Saskatoon, Canada, S7M 2W2

More Information

Sponsor

Arrowhead Pharmaceuticals

Last update posted

Jun 23, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Arrowhead Pharmaceuticals on 2026-06-23.