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Recruiting NCT07241546

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

Phase II Interventional Asthma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ARO-RAGE, Placebo.
Who it may be relevant to
Registry conditions: Asthma. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized, Double-blind, Placebo-controlled Phase 2a Study of ARO-RAGE Inhalation Solution to Assess Efficacy on Small Airway Dysfunction in Allergen-induced Mild Asthma

Overview

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.

Interventions

  • Drug ARO-RAGE
    Inhalation of nebulized solution
  • Drug Placebo
    Calculated volume to match active treatment by inhalation of nebulized solution

Primary outcome measures

  • Change from Baseline Over Time in Maximum Area of Reactance [Time frame: Baseline through Day 58]
Secondary outcome measures (3)
  • Change from Baseline Over Time in Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve [Time frame: Baseline through Day 58]
  • Change from Baseline Over Time in Maximum Change in Small Airway Reactance [Time frame: Baseline through Day 58]
  • Number of Participants with Treatment-Emergent Adverse Events [Time frame: Up to Day 113 (End of Study)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Canada · 5 centers
  • Research Site 1 — Vancouver
  • Research Site 2 — Calgary
  • Research Site 3 — Edmonton
  • Research Site 5 — Hamilton
  • Research Site 4 — Saskatoon

Identifiers

NCT: NCT07241546 · ARORAGE-2001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗