Clinical trial

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

Name

EP-262-102

Description

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

Trial arms

Trial start

2023-08-30

Estimated PCD

2024-09-01

Trial end

2024-11-01

Status

Recruiting

Phase

Early phase I

Treatment

Oral EP262

Once daily

Arms:

EP262 150 mg

Size

Primary endpoint

Safety and tolerability of EP262

Measured from Day 1 to End of Study or Early Termination (up to 12 weeks)

Eligibility criteria

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)

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

Updated at

2024-04-17

1 organization

1 product

1 indication

Organization

Escient Pharmaceuticals

Product

EP262

Indication

Chronic Inducible Urticaria