NCT06927999 · ARS Pharmaceuticals, Inc.
An Outpatient Study of the Efficacy of ARS-2 in Patients With Chronic Spontaneous Urticaria
What this study is about
This is a Phase 2b, outpatient, single-dose, randomly assigned, double blind, compared against an inactive treatment, 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).
View original scientific description
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).
Interventions
DRUG
Placebo
Placebo solution nasal spray containing no active drug
DRUG
0.5 mg epinephrine
0.5 mg epinephrine per spray
DRUG
1 mg epinephrine
1 mg epinephrine per spray
Primary outcome measures
Determine the effect of ARS-2 (0.5 mg or 1 mg) versus placebo on itch and hive
Time frame: 12 months
Change in itch and hive scores (Uniform Assessment System) \[UAS\] as compared to placebo at each timepoint on exacerbation days
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Glenview, Illinois
- Cincinnati, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 2, 2025 · Source of record for eligibility and locations