Phase 1b, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of EP262 in Subjects With Chronic Inducible Urticaria

Completed · Phase 1

Conditions studied: Chronic Inducible Urticaria

In brief

This phase 1b trial will evaluate the effects of EP262 in subjects with Chronic Inducible Urticaria (CIndU), including symptomatic dermographism and cold urticaria.

Key facts

Study ID

NCT06050928

Run by

Escient Pharmaceuticals, Inc

People needed

33

Starts

2023-08-30

Expected to finish

2024-10-22

Last updated by the study team

2024-12-09

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Advanced Clinical Research Institute — Tampa, Florida, United States
• Treasure Valley Medical Research — Boise, Idaho, United States
• Allergy & Asthma Specialists, P.S.C. — Owensboro, Kentucky, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Bernstein Clinical Research Center, LLC — Cincinnati, Ohio, United States
• Allergy and Clinical Immunology Associates — Pittsburgh, Pennsylvania, United States
• National Allergy and Asthma Research, LLC. — North Charleston, South Carolina, United States
• Innovaderm Research Inc. — Montreal, Canada
• Gordon Sussman Clinical Research Inc. — North York, Canada
• Medizinische Hochschule Hannover — Hanover, Lower Saxony, Germany
• Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden — Dresden, Saxony, Germany
• Institut fur Allergieforschung Charite - Universitatsmedizin Berlin — Berlin, Germany
• Centre for Human Drug Research (CHDR) — Leiden, South Holland, Netherlands
• Hospital del Mar — Barcelona, Spain
• Hospital Arnau de Vilanova — Valencia, Spain

Full record on ClinicalTrials.gov

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