Actively Recruiting
An Outpatient Study of the Efficacy of ARS-2 in Patients With Chronic Spontaneous Urticaria
Led by ARS Pharmaceuticals, Inc. · Updated on 2025-10-02
42
Participants Needed
3
Research Sites
46 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
An Outpatient Study of the Efficacy of ARS-2 in Patients With Chronic Spontaneous Urticaria
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female between 18 and 65 years old
- Clinically diagnosed with chronic spontaneous urticaria (CSU) with moderate to severe flare-ups (itch and hive severity UAS score ≥ 2) about 1-2 times a month or every other month consistently in the past year
- On daily chronic treatment for 6 weeks or more
- Willing to use a smartphone app to record study assessments and adverse events
- Body weight greater than 15 kilograms
- No history of clinically significant hypertension or cardiovascular disease in the last 10 years
- If female, not pregnant or breastfeeding with a negative urine pregnancy test at baseline
- Able to communicate clearly, read, complete questionnaires, and use the smartphone app
- Willing and able to provide written informed consent
- Controlled hypertension without beta blocker is acceptable
- Stable vital signs at screening after 5 minutes rest: systolic blood pressure 90-140 mmHg, diastolic blood pressure 50-90 mmHg, heart rate 45-100 bpm
You will not qualify if you...
- History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease
- Any clinically significant medical condition or physical exam finding deemed inappropriate by the Investigator
- Abnormal cardiovascular exam including prior myocardial infarction or clinically significant abnormal ECG
- Significant traumatic injury or major surgery within 30 days prior to screening
- Known hypersensitivity to compounds in the test product or related compounds
- Participation in another clinical trial within 30 days before first study drug dose
- Immediate family member or dependent of the Investigator or study center employee involved in this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Endeavor Health Clinical Trials Center
Glenview, Illinois, United States, 60026
Actively Recruiting
2
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio, United States, 45236
Actively Recruiting
3
Institute of Allergology IFA Charité - Campus Benjamin Franklin | Hindenburgdamm 30
Berlin, Germany, 12203
Not Yet Recruiting
Research Team
O
Osnat Ehrman, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
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