ClinicalTrials.Veeva

Menu

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

E

Escient Pharmaceuticals

Status and phase

Completed
Phase 1

Conditions

Chronic Inducible Urticaria

Treatments

Drug: Oral EP262

Study type

Interventional

Funder types

Industry

Identifiers

NCT06050928
EP-262-102

Details and patient eligibility

About

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

Enrollment

33 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

33 participants in 1 patient group

EP262 150 mg
Experimental group
Description:
Once daily
Treatment:
Drug: Oral EP262

Trial contacts and locations

16

Loading...

Central trial contact

Escient Clinical Trials

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems