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This phase 1b trial will evaluate the effects of EP262 in subjects with Chronic Inducible Urticaria (CIndU), including symptomatic dermographism and cold urticaria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EP262 150 mg | Experimental | Once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral EP262 | Drug | Once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of EP262 | Assessed by the incidence of treatment-emergent adverse events | Measured from Day 1 to End of Study or Early Termination (up to 12 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Critical Friction Threshold (CFT) | Assessed by the number of prongs that elicit a wheal response using a FricTest (in subjects with symptomatic dermographism) | Measured from Baseline to Week 4 |
| Change in Critical Temperature Threshold (CTT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Clinical Research Institute | Tampa | Florida | 33607 | United States | ||
| Treasure Valley Medical Research |
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Assessed as the highest temperature that elicits a wheal response using a TempTest (in subjects with cold urticaria)
| Measured from Baseline to Week 4 |
| Boise |
| Idaho |
| 83706 |
| United States |
| Allergy & Asthma Specialists, P.S.C. | Owensboro | Kentucky | 42301 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21224 | United States |
| Bernstein Clinical Research Center, LLC | Cincinnati | Ohio | 45236 | United States |
| Allergy and Clinical Immunology Associates | Pittsburgh | Pennsylvania | 15241 | United States |
| National Allergy and Asthma Research, LLC. | North Charleston | South Carolina | 29420 | United States |
| Innovaderm Research Inc. | Montreal | H2X 2V1 | Canada |
| Gordon Sussman Clinical Research Inc. | North York | M3B 3S6 | Canada |
| Medizinische Hochschule Hannover | Hanover | Lower Saxony | 30625 | Germany |
| Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden | Dresden | Saxony | 01307 | Germany |
| Institut fur Allergieforschung Charite - Universitatsmedizin Berlin | Berlin | 12203 | Germany |
| Centre for Human Drug Research (CHDR) | Leiden | South Holland | 2333 CL | Netherlands |
| Hospital del Mar | Barcelona | 08003 | Spain |
| Hospital Arnau de Vilanova | Valencia | 46015 | Spain |
| ID | Term |
|---|---|
| D000094482 | Chronic Inducible Urticaria |
| ID | Term |
|---|---|
| D000080223 | Chronic Urticaria |
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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