AsthmaPhase 2NCT07241546
Study of Inhaled ARO-RAGE in Allergen-induced Mild Asthma
A Phase 2 study testing ARO-RAGE in people with Asthma, run by Arrowhead Pharmaceuticals at 6 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- ARO-RAGE
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 6 sitesCanada
- Study dates
- 30 Mar 2026to Apr 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Canada6 sites, 6 recruiting
- Recruiting
Research Site 2
Calgary, T2N 4N1
- Recruiting
Research Site 3
Edmonton, T6G 2G3
- Recruiting
Research Site 5
Hamilton, L8N 3Z5
- Recruiting
Research Site 6
Québec, G1V-4G5
- Recruiting
Research Site 4
Saskatoon, S7M 2W2
- Recruiting
Research Site 1
Vancouver, British Columbia, V5Z 1M9
About this study
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
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
- Being tested
- ARO-RAGE, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARO-RAGEDrug
Inhalation of nebulized solution
PlaceboDrug
Calculated volume to match active treatment by inhalation of nebulized solution
| Study group | Role | What they receive |
|---|---|---|
| ARO-RAGE | Experimental | ARO-RAGE inhalation Receives: Drug: ARO-RAGE |
| Placebo | Placebo comparator | Normal saline (0.9%) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Over Time in Maximum Area of Reactance
Measured: Baseline through Day 58
Secondary outcomes (3)
Change from Baseline Over Time in Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve
Measured: Baseline through Day 58
Change from Baseline Over Time in Maximum Change in Small Airway Reactance
Measured: Baseline through Day 58
Number of Participants with Treatment-Emergent Adverse Events
Measured: Up to Day 113 (End of Study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start30 Mar 2026
- Primary completionDec 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Arrowhead PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arrowhead Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07241546
- Sponsor's protocol ID
- ARORAGE-2001
- Status last verified
- Sep 2026
- First submitted
- 17 Nov 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No