Clinical trial NCT06050928: Phase 1b, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of EP262 in Subjects With Chronic Inducible Urticaria
Official title: Phase 1b, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of EP262 in Subjects With Chronic Inducible Urticaria (CALM-CIndU)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Inducible Urticaria
Lead sponsor: Escient Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2023-09-22
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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)

Primary outcomes:
measure: Safety and tolerability of EP262
timeFrame: Measured from Day 1 to End of Study or Early Termination (up to 12 weeks)
Secondary outcomes:
measure: Change in Critical Friction Threshold (CFT)
timeFrame: Measured from Baseline to Week 4
measure: Change in Critical Temperature Threshold (CTT)
timeFrame: Measured from Baseline to Week 4
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Advanced Clinical Research Institute
state: Florida
city: Boise
country: United States
facility: Treasure Valley Medical Research
state: Idaho
city: Owensboro
country: United States
facility: Allergy & Asthma Specialists, P.S.C.
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Cincinnati
country: United States
facility: Bernstein Clinical Research Center, LLC
state: Ohio
city: Pittsburgh
country: United States
facility: Allergy and Clinical Immunology Associates
state: Pennsylvania
city: North Charleston
country: United States
facility: National Allergy and Asthma Research, LLC.
state: South Carolina
city: Montréal
country: Canada
facility: Innovaderm Research Inc.
city: North York
country: Canada
facility: Gordon Sussman Clinical Research Inc.
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
state: Niedersachsen
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
state: Sachsen
city: Berlin
country: Germany
facility: Institut fur Allergieforschung Charite - Universitatsmedizin Berlin
city: Leiden
country: Netherlands
facility: Centre for Human Drug Research (CHDR)
state: South Holland
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Valencia
country: Spain
facility: Hospital Arnau de Vilanova
Study officials:
References: