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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo solution nasal spray containing no active drug will be administered using the commercial sprayer device. |
|
| 0.5 mg | Active Comparator | 0.5 mg epinephrine per spray |
|
| 1 mg | Active Comparator | 1 mg epinephrine per spray |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo solution nasal spray containing no active drug |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the effect of ARS-2 (0.5 mg or 1 mg) versus placebo on itch and hive | Change in itch and hive scores (Uniform Assessment System) [UAS] as compared to placebo at each timepoint on exacerbation days | 12 months |
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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):
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Osnat Ehrman, MSc | Contact | 952.334.5797 | osnate@pacificlinkconsulting.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endeavor Health Clinical Trials Center | Recruiting | Glenview | Illinois | 60026 | United States |
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| ID | Term |
|---|---|
| D000080223 | Chronic Urticaria |
| ID | Term |
|---|---|
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| 0.5 mg epinephrine |
| Drug |
0.5 mg epinephrine per spray |
|
| 1 mg epinephrine | Drug | 1 mg epinephrine per spray |
|
| Bernstein Clinical Research Center, LLC | Recruiting | Cincinnati | Ohio | 45236 | United States |
|
| Institute of Allergology IFA Charité - Campus Benjamin Franklin | Hindenburgdamm 30 | Not yet recruiting | Berlin | 12203 | Germany |
| D006969 |
| Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000588 |
| Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |