Outpatient test of ARS-2 for chronic spontaneous urticaria

An Outpatient, Randomized, Double-Blinded, Placebo-Controlled, Cross-Over Study of the Efficacy of ARS-2 in Patients With Chronic Spontaneous Urticaria

This trial tests whether a single outpatient dose of ARS-2 helps adults with chronic spontaneous urticaria during moderate-to-severe flares.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: ARS Pharmaceuticals, Inc. (Industry-sponsored)
• Locations: 3 sites (Glenview, Illinois and 2 other locations)
• Trial ID: NCT06927999 on ClinicalTrials.gov

What this trial studies

This is a Phase 2b, randomized, double-blind, placebo-controlled, three-period crossover outpatient trial with a screening period and three blinded treatment periods. Adults with chronic spontaneous urticaria who have had recurrent moderate-to-severe flares while on chronic therapy will receive a single dose of either placebo, 0.5 mg epinephrine, or 1 mg epinephrine in each treatment period. Participants will record symptoms and adverse events using a smartphone study application and be monitored at participating clinical sites. The crossover design lets each participant receive all three treatments in separate periods so responses can be compared within individuals.

Who should consider this trial

Good fit: Adults aged 18–65 with clinically diagnosed chronic spontaneous urticaria who experience moderate-to-severe flares about once every one to two months while on chronic therapy and who can use a smartphone app and give informed consent are ideal candidates.

Not a fit: People with only mild CSU, recent clinically significant cardiovascular disease or uncontrolled hypertension, pregnant or breastfeeding people, or those unable to use the smartphone app are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this could provide a rapid single-dose option to reduce the severity or duration of flares for people with chronic spontaneous urticaria.

How similar studies have performed: Using low-dose epinephrine for CSU flares is relatively novel and has limited controlled trial data to date.

Eligibility criteria

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 clinically significant 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 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)

Exclusion Criteria:

* 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.

Where this trial is running

Glenview, Illinois and 2 other locations

• Endeavor Health Clinical Trials Center — Glenview, Illinois, United States (Recruiting)
• Bernstein Clinical Research Center, LLC — Cincinnati, Ohio, United States (Recruiting)
• Institute of Allergology IFA Charité - Campus Benjamin Franklin | Hindenburgdamm 30 — Berlin, Germany (Not_yet_recruiting)

Study contacts

• Study coordinator: Osnat Ehrman, MSc

Conditions Urticaria Chronic