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

NCT ID: NCT07241546

Last Updated: 2025-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2028-04-30

Brief Summary

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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

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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ARO-RAGE

ARO-RAGE inhalation

Group Type EXPERIMENTAL

ARO-RAGE

Intervention Type DRUG

Inhalation of nebulized solution

Placebo

Normal saline (0.9%)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Calculated volume to match active treatment by inhalation of nebulized solution

Interventions

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ARO-RAGE

Inhalation of nebulized solution

Intervention Type DRUG

Placebo

Calculated volume to match active treatment by inhalation of nebulized solution

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arrowhead Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Medical Monitor

Role: CONTACT

626-304-3400

Other Identifiers

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ARORAGE-2001

Identifier Type: -

Identifier Source: org_study_id

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