Chronic Inducible Urticaria
Conditions
Brief summary
This phase 1b trial will evaluate the effects of EP262 in subjects with Chronic Inducible Urticaria (CIndU), including symptomatic dermographism and cold urticaria.
Interventions
DRUGOral EP262
Once daily
Sponsors
Escient Pharmaceuticals, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of CIndU (symptomatic dermographism or cold urticaria) for greater than 3 months and positive response to applicable skin provocation testing * Willing to discontinue chronic treatment with antihistamines during the study
Exclusion criteria
* Urticaria with a clear underlying etiology other than symptomatic dermographism or cold urticaria * Other active skin diseases that might confound the study evaluations (eg, atopic dermatitis, bullous pemphigoid, prurigo nodularis, dermatitis herpetiformis) * Regularly experience wheals covering the area of the body where skin testing will be conducted (eg, more than one third of the volar surface of the forearms)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of EP262 | Measured from Day 1 to End of Study or Early Termination (up to 12 weeks) | Assessed by the incidence of treatment-emergent adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Critical Friction Threshold (CFT) | Measured from Baseline to Week 4 | Assessed by the number of prongs that elicit a wheal response using a FricTest (in subjects with symptomatic dermographism) |
| Change in Critical Temperature Threshold (CTT) | Measured from Baseline to Week 4 | Assessed as the highest temperature that elicits a wheal response using a TempTest (in subjects with cold urticaria) |
Countries
Canada, Germany, Netherlands, Spain, United States
Outcome results
None listed