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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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)

Locations
United States
Illinois
Endeavor Health Clinical Trials Center
RECRUITING
Glenview
Ohio
Bernstein Clinical Research Center, LLC
RECRUITING
Cincinnati
Other Locations
Germany
Institute of Allergology IFA Charité - Campus Benjamin Franklin | Hindenburgdamm 30
NOT_YET_RECRUITING
Berlin
Contact Information
Primary
Osnat Ehrman, MSc
osnate@pacificlinkconsulting.com
952.334.5797
Time Frame
Start Date: 2025-07-09
Estimated Completion Date: 2026-06
Participants
Target number of participants: 42
Treatments
Placebo_comparator: Placebo
Placebo solution nasal spray containing no active drug will be administered using the commercial sprayer device.
Active_comparator: 0.5 mg
0.5 mg epinephrine per spray
Active_comparator: 1 mg
1 mg epinephrine per spray
Sponsors
Leads: ARS Pharmaceuticals, Inc.

This content was sourced from clinicaltrials.gov

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