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

Arrowhead Pharmaceuticals

Status and phase: Not yet enrolling; Phase 2

Conditions: Asthma

Treatments: Drug: Placebo; Drug: ARO-RAGE

Study type: Interventional

Funder types: Industry

Identifiers

NCT07241546

ARORAGE-2001

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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36 participants in 2 patient groups, including a placebo group

ARO-RAGE

Experimental group

Description:

ARO-RAGE inhalation

Treatment:

Drug: ARO-RAGE

Placebo

Placebo Comparator group

Description:

Normal saline (0.9%)

Treatment:

Drug: Placebo