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RecruitingNCT06927999Updated Sep 16, 2026

An Outpatient Study of the Efficacy of ARS-2 in Patients With Chronic Spontaneous Urticaria

A Phase 2 interventional study of Placebo and 0.5 mg epinephrine in Urticaria Chronic, sponsored by ARS Pharmaceuticals, Inc.. Recruiting at 3 sites in 2 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by ARS Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2025; still recruiting 1 year 4 months later.

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Phase
Phase 2
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 64 studies in Chronic Urticaria with a site in United States — 9 open to participants now, 17 under way, 6 of them phase 3. Chronic Urticaria · United States.

Planned enrollment
45th of 58
42 · median 132
Started
2025
with 8 others
Phase 2
23 of 64
4 open now
Primary completion
2027-06
later than 10 of 16 live
Registered
55th of 64
by date

Among the 64 studies in Chronic Urticaria with a site in United States, this one is the 45th largest by planned enrollment of the 58 interventional ones that give a count, is one of 9 that started in 2025, is one of 23 in phase 2, reaches primary completion later than 10 of the 16 other live ones, and was the 55th registered.

Chronic Urticaria

196 studies on the registry are indexed under Chronic Urticaria; 48 are open to participants now.

Browse Chronic Urticaria studies →

Open to participants now

9 of the 64 studies in Chronic Urticaria with a site in United States are open now. Recruiting first, the newest first:

3 more — sign in →

All 9 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 25 Chronic Urticaria studies recruiting now, 11 (44%) set no upper age limit and 10 (40%) stop at 75 or younger; 1 takes children under 18; 6 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 64 studies in Chronic Urticaria with a site in United States, or all of them as a file.
02

Study 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).

03

Conditions studied

  • Urticaria Chronic

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04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 hypertension and cardiovascular disease in the last 10 years
  • 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 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)

Exclusion criteria

Exclusion Criteria:

  • Has a history of 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 (ECG)
  • Has had significant traumatic injury or major surgery within 30 days prior to study screening.
  • Known 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.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
42 participants (estimated)

Study arms

  • Placebo comparator
    Placebo

    Placebo solution nasal spray containing no active drug will be administered using the commercial sprayer device.

    Drug: Placebo

  • Active comparator
    0.5 mg

    0.5 mg epinephrine per spray

    Drug: 0.5 mg epinephrine

  • Active comparator
    1 mg

    1 mg epinephrine per spray

    Drug: 1 mg epinephrine

Interventions

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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

    Time frame: 12 months

07

Study locations

2 of 3 sites recruiting
  • Endeavor Health Clinical Trials Center
    Glenview, Illinois 60026, United States
    Recruiting
    • Giselle Mosnaim, MD · Contact
  • Bernstein Clinical Research Center, LLC
    Cincinnati, Ohio 45236, United States
    Recruiting
    • Jonathan A. Bernstein · Principal investigator
  • Institute of Allergology IFA Charité - Campus Benjamin Franklin | Hindenburgdamm 30
    Berlin, 12203, Germany
    Not yet recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2025 (actual). Primary completion is estimated for Jun 2027, 23 months after the start.

Of 31 phase 2 interventional studies under Chronic Urticaria, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 31. This study's planned 23 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 4, 2025
First posted
Apr 15, 2025
StartActual
Jul 9, 2025
Primary completionEst.
Jun 2027
CompletionEst.
Jun 2027
Last update
Sep 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06927999
Lead sponsor
ARS Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Apr 15, 2025
Start date
Jul 9, 2025
Primary completion
Jun 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Sep 16, 2026

Study contacts

Osnat Ehrman, MSc
Contact
osnate@pacificlinkconsulting.com
952.334.5797

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Discussion

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Studies of the drug tested here: Epinephrine

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Other studies from this sponsor

ARS Pharmaceuticals, Inc.

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