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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07241546
- Acronym / sponsor ID
- ARORAGE-2001
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Arrowhead PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARO-RAGE | Experimental | Drug: ARO-RAGEARO-RAGE inhalation |
| Placebo | Placebo comparator | Drug: PlaceboNormal saline (0.9%) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARO-RAGEInhalation of nebulized solution | Drug | ARO-RAGE |
| PlaceboCalculated volume to match active treatment by inhalation of nebulized solution | Drug | Placebo |
Primary outcome
Change from Baseline Over Time in Maximum Area of Reactance
Time frame: Baseline through Day 58
3 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ARO-RAGE in people with Asthma, run by Arrowhead Pharmaceuticals at 6 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Medical Monitor (626-304-3400, ARORAGE-2001@arrowheadpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Over Time in Maximum Area of Reactance (time frame: Baseline through Day 58). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.