Outpatient test of ARS-2 for chronic spontaneous urticaria

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: osnate@pacificlinkconsulting.com
• Phone: 952.334.5797

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Mediterranean and Low-Histamine Diets for pediatric chronic spontaneous urticaria

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• BBT001 in adults with chronic spontaneous urticaria

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• Remibrutinib for adults with chronic spontaneous urticaria in routine care

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.