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

ClinicalTrials.gov ID NCT06927999 · An Outpatient, Randomized, Double-Blinded, Placebo-Controlled, Cross-Over Study of the Efficacy of ARS-2 in Patients With Chronic Spontaneous Urticaria

Check if you may qualify View the official record

At a glance

Status
Recruiting
Condition
Urticaria Chronic
Phase
Phase 2
Ages
18 Years to 65 Years
Sex
All
Healthy volunteers
Not accepted
What is being studied
Placebo (drug); 0.5 mg epinephrine (drug); 1 mg epinephrine (drug)
Sponsor
ARS Pharmaceuticals, Inc.
Target enrollment
42 participants
Study sites
3 open in Germany, Illinois, Ohio
Start date
2025-07-09
Primary completion
2027-06

Common questions

Is NCT06927999 still recruiting?

ClinicalTrials.gov lists this trial as recruiting (checked 5 October 2026). It has 3 open or upcoming sites.

Who can take part in NCT06927999?

The record lists people aged 18 to 65 years with urticaria chronic. The study team decides who is eligible, and the full criteria are on this page and in the official record.

Where is NCT06927999 running?

3 sites in Germany, Illinois, Ohio, according to ClinicalTrials.gov.

What is being studied in NCT06927999?

It is a Phase 2 trial. The record lists these interventions: Placebo, 0.5 mg epinephrine and 1 mg epinephrine. The sponsor is ARS Pharmaceuticals, Inc.

How many people will NCT06927999 enroll?

The record gives a target of 42 participants.

How do I sign up for NCT06927999?

Use "Check if you may qualify" on this page to answer a few screening questions, or contact the study team listed on ClinicalTrials.gov.

About this trial

From the ClinicalTrials.gov record.

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).

Where it's running

SiteCityStateStatus
Endeavor Health Clinical Trials CenterGlenviewIllinoisRecruiting
Bernstein Clinical Research Center, LLCCincinnatiOhioRecruiting
Institute of Allergology IFA Charité - Campus Benjamin Franklin | Hindenburgdamm 30BerlinGermanyNot yet recruiting
Full eligibility criteria (from the record)

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.

Other recruiting trials: Chronic hives (chronic urticaria) clinical trials

This listing shows only what the public ClinicalTrials.gov record NCT06927999 says, last updated there on 2026-09-16. It was checked against the registry on 5 October 2026. Taking part is voluntary, and the study team decides who is eligible. For the most current details, see the official record.