Status:
COMPLETED
Phase 1b, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of EP262 in Subjects With Chronic Inducible Urticaria
Lead Sponsor:
Escient Pharmaceuticals, Inc
Conditions:
Chronic Inducible Urticaria
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 22 2024
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT06050928
Start Date
August 30 2023
End Date
October 22 2024
Last Update
December 9 2024
Active Locations (15)
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1
Advanced Clinical Research Institute
Tampa, Florida, United States, 33607
2
Treasure Valley Medical Research
Boise, Idaho, United States, 83706
3
Allergy & Asthma Specialists, P.S.C.
Owensboro, Kentucky, United States, 42301
4
Johns Hopkins University
Baltimore, Maryland, United States, 21224