Urticaria ChronicPhase 2NCT06927999
An Outpatient Study of the Efficacy of ARS-2 in Patients With Chronic Spontaneous Urticaria
A Phase 2 study testing 0.5 mg epinephrine and 1 mg epinephrine in people with Urticaria Chronic, run by ARS Pharmaceuticals, Inc. at 3 sites in 2 countries.
Trial summary
This is a Phase 2b, outpatient, single-dose, randomized, double blind, placebo-controlled, three period crossover study that will consist of a screening period and three blinded treatment periods. Subjects enrolled will have CSU with a history of moderate to severe acute exacerbations (or flares). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Urticaria Chronic
- What is being tested?
- 0.5 mg epinephrine and 1 mg epinephrine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 9 Jul 2025to Jun 2027
- 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
- Is a male or female between the ages of 18 and 65 years, inclusive.
- Has been clinically diagnosed with CSU and experiences an acute flare of moderate to severe urticaria symptoms (itch and hive severity UAS score ≥ 2) approximately 1-2 times a month or every other month consistently during the past year while on a chronic treatment.
- Has been on a daily chronic treatment for ≥ 6 weeks.
- Is willing to use a smartphone study application to record study assessments and AEs.
- Has body weight more than 15 kilogram (kg).
- Has no medical history of clinically significant hypertension and cardiovascular disease in the last 10 years
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- If female, is not pregnant or breastfeeding based on a negative urine pregnancy test at baseline.
- Is able to communicate clearly with the Investigator and staff; able to read, complete questionnaires, and perform study procedures on the smartphone study application.
- Is willing and able to provide written informed consent prior to participating in the study.
- Controlled hypertension without beta blocker confirmed by the Investigator is acceptable.
- At screening, has stable vital signs in the following ranges (after 5 minutes of rest):
- Systolic blood pressure (SBP) ≥90 and ≤140 milliliters of mercury (mmHg)
- Diastolic blood pressure (DBP) ≥50 and ≤90 mmHg
- Heart rate (HR) ≥45 and ≤100 beats per minute (bpm)
Who cannot join
- Has a history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
- Has any clinically significant medical condition or PE finding as deemed inappropriate by the Investigator.
- Has abnormal cardiovascular exam at screening including any prior history of myocardial infarction or clinically significant abnormal electrocardiogram (ECG)
- Has had significant traumatic injury or major surgery within 30 days prior to study screening.
- Known hypersensitivity to any compound in the test product, or any other closely related compound (e.g., dihydropyridine-derived molecules).
- Has participated in a clinical trial within 30 days prior to the first dose of study drug.
- Has an immediate family member of the Investigator, or an employee of the study center, with direct involvement in the proposed study, or other studies under the direction of the Investigator or study center or is in a dependent relationship with a study center employee who is involved in the conduct of this study (e.g., spouse, parent, child, sibling), or may consent under duress.
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
United States2 sites, 2 recruiting
- Recruiting
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio, 45236
Jonathan A. Bernstein
- Recruiting
Endeavor Health Clinical Trials Center
Glenview, Illinois, 60026
Giselle Mosnaim, MD
Germany1 site, 1 recruiting
- Not yet recruiting
Institute of Allergology IFA Charité - Campus Benjamin Franklin | Hindenburgdamm 30
Berlin, 12203
About this study
Official title: An Outpatient, Randomized, Double-Blinded, Placebo-Controlled, Cross-Over Study of the Efficacy of ARS-2 in Patients With Chronic Spontaneous Urticaria
This is a Phase 2b, outpatient, single-dose, randomized, double blind, placebo-controlled, three period crossover study that will consist of a screening period and three blinded treatment periods. Subjects enrolled will have CSU with a history of moderate to severe acute exacerbations (or flares).
- Conditions
- Urticaria Chronic
- Being tested
- Placebo, 0.5 mg epinephrine, 1 mg epinephrine
- Medical subject headings
- Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo solution nasal spray containing no active drug
0.5 mg epinephrineDrug
0.5 mg epinephrine per spray
1 mg epinephrineDrug
1 mg epinephrine per spray
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo solution nasal spray containing no active drug will be administered using the commercial sprayer device. Receives: Drug: Placebo |
| 0.5 mg | Active comparator | 0.5 mg epinephrine per spray Receives: Drug: 0.5 mg epinephrine |
| 1 mg | Active comparator | 1 mg epinephrine per spray Receives: Drug: 1 mg epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the effect of ARS-2 (0.5 mg or 1 mg) versus placebo on itch
Change in itch scores (Uniform Assessment System) - Range is a scale of 0-3. Zero is none and 3 is severe.
[UAS] as compared to placebo at each timepoint on exacerbation days
Measured: 12 months
Secondary outcomes (1)
Determine the effect of ARS-2 (0.5 mg or 1 mg) versus placebo on hive
Change in hive scores (Uniform Assessment System) - Range is a scale of 0-3. Zero is none and 3 is severe.
[UAS] as compared to placebo at each timepoint on exacerbation days
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start9 Jul 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urticaria ChronicStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ARS Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06927999
- Sponsor's protocol ID
- EPI U02
- Status last verified
- Sep 2026
- First submitted
- 4 Apr 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Outpatient, Randomized, Double-Blinded, Placebo-Controlled, Cross-Over Study of the Efficacy of ARS-2 in Patients With Chronic Spontaneous Urticaria
- ClinicalTrials.gov ID
- NCT06927999
- Acronym / sponsor ID
- EPI U02
- Conditions
- Urticaria Chronic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- ARS Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Jul 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 15 Apr 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.
This is a Phase 2b, outpatient, single-dose, randomized, double blind, placebo-controlled, three period crossover study that will consist of a screening period and three blinded treatment periods. Subjects enrolled will have CSU with a history of moderate to severe acute exacerbations (or flares).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo solution nasal spray containing no active drug will be administered using the commercial sprayer device. |
| 0.5 mg | Active comparator | Drug: 0.5 mg epinephrine0.5 mg epinephrine per spray |
| 1 mg | Active comparator | Drug: 1 mg epinephrine1 mg epinephrine per spray |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Is a male or female between the ages of 18 and 65 years, inclusive.
- Has been clinically diagnosed with CSU and experiences an acute flare of moderate to severe urticaria symptoms (itch and hive severity UAS score ≥ 2) approximately 1-2 times a month or every other month consistently during the past year while on a chronic treatment.
- Has been on a daily chronic treatment for ≥ 6 weeks.
- Is willing to use a smartphone study application to record study assessments and AEs.
- Has body weight more than 15 kilogram (kg).
Key exclusion criteria (7 listed)
- Has a history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
- Has any clinically significant medical condition or PE finding as deemed inappropriate by the Investigator.
- Has abnormal cardiovascular exam at screening including any prior history of myocardial infarction or clinically significant abnormal electrocardiogram (ECG)
- Has had significant traumatic injury or major surgery within 30 days prior to study screening.
- Known hypersensitivity to any compound in the test product, or any other closely related compound (e.g., dihydropyridine-derived molecules).
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 |
|---|---|---|
| PlaceboPlacebo solution nasal spray containing no active drug | Drug | Placebo |
| 0.5 mg epinephrine0.5 mg epinephrine per spray | Drug | 0.5 mg |
| 1 mg epinephrine1 mg epinephrine per spray | Drug | 1 mg |
Primary outcome
Determine the effect of ARS-2 (0.5 mg or 1 mg) versus placebo on itch
Time frame: 12 months
Change in itch scores (Uniform Assessment System) - Range is a scale of 0-3. Zero is none and 3 is severe. [UAS] as compared to placebo at each timepoint on exacerbation days
1 secondary outcome
Determine the effect of ARS-2 (0.5 mg or 1 mg) versus placebo on hive
Time frame: 12 months
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 16 Sep 2026.
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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.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 0.5 mg epinephrine and 1 mg epinephrine in people with Urticaria Chronic, run by ARS Pharmaceuticals, Inc. at 3 sites in 2 countries.
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 14 inclusion and 7 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 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Germany. 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 Osnat Ehrman, MSc (952.334.5797, osnate@pacificlinkconsulting.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the effect of ARS-2 (0.5 mg or 1 mg) versus placebo on itch (time frame: 12 months). 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 16 Sep 2026.