Study of Inhaled ARO-RAGE in Allergen-induced Mild Asthma | NCT07241546

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

NCT07241546

Sponsor

Arrowhead Pharmaceuticals

Status

Recruiting

Last Update Posted

Jun 23, 2026Actual

Enrollment

36Estimated

Phase

Phase 2

Conditions

Asthma

Interventions

ARO-RAGE
Placebo

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 30, 2026Actual

Primary Completion Date

Dec 2027Estimated

Completion Date

Apr 2028Estimated

First Submitted Date

Nov 17, 2025

First Submission Date that Met QC Criteria

Nov 17, 2025

First Posted Date

Nov 21, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 22, 2026

Last Update Posted Date

Jun 23, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ARO-RAGE	Experimental	ARO-RAGE inhalation	Drug: ARO-RAGE
Placebo	Placebo Comparator	Normal saline (0.9%)	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ARO-RAGE	Drug	Inhalation of nebulized solution	ARO-RAGE
Placebo

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Medical Monitor	Contact	626-304-3400		ARORAGE-2001@arrowheadpharma.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site 1	Recruiting	Vancouver	British Columbia		Canada
Research Site 2

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided