Back to resultsPhase 1b, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of EP262 in Subjects With Chronic Inducible Urticaria (CALM-CIndU)
Primary Purpose
Chronic Inducible Urticaria
Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Oral EP262
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Inducible 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)
Sites / Locations
- Advanced Clinical Research InstituteRecruiting
- Treasure Valley Medical ResearchRecruiting
- Allergy and Clinical Immunology AssociatesRecruiting
- National Allergy and Asthma Research, LLC.Recruiting
- Innovaderm Research Inc.Recruiting
- Gordon Sussman Clinical Research Inc.Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EP262 150 mg
Arm Description
Once daily
Outcomes
Primary Outcome Measures
Safety and tolerability of EP262
Assessed by the incidence of treatment-emergent adverse events
Secondary Outcome Measures
Change in Critical Friction Threshold (CFT)
Assessed by the number of prongs that elicit a wheal response using a FricTest (in subjects with symptomatic dermographism)
Change in Critical Temperature Threshold (CTT)
Assessed as the highest temperature that elicits a wheal response using a TempTest (in subjects with cold urticaria)
Full Information
NCT ID
NCT06050928
First Posted
September 7, 2023
Last Updated
September 18, 2023
Sponsor
Escient Pharmaceuticals, Inc
1. Study Identification
Unique Protocol Identification Number
NCT06050928
Brief Title
Phase 1b, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of EP262 in Subjects With Chronic Inducible Urticaria
Acronym
CALM-CIndU
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Escient Pharmaceuticals, Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Inducible Urticaria
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EP262 150 mg
Arm Type
Experimental
Arm Description
Once daily
Intervention Type
Drug
Intervention Name(s)
Oral EP262
Intervention Description
Once daily
Primary Outcome Measure Information:
Title
Safety and tolerability of EP262
Description
Assessed by the incidence of treatment-emergent adverse events
Time Frame
Measured from Day 1 to End of Study or Early Termination (up to 12 weeks)
Secondary Outcome Measure Information:
Title
Change in Critical Friction Threshold (CFT)
Description
Assessed by the number of prongs that elicit a wheal response using a FricTest (in subjects with symptomatic dermographism)
Time Frame
Measured from Baseline to Week 4
Title
Change in Critical Temperature Threshold (CTT)
Description
Assessed as the highest temperature that elicits a wheal response using a TempTest (in subjects with cold urticaria)
Time Frame
Measured from Baseline to Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Escient Clinical Trials
Phone
858-617-8220
Email
clinicaltrials@escientpharma.com
Facility Information:
Facility Name
Advanced Clinical Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francis Caban
Facility Name
Treasure Valley Medical Research
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neetu Talreja
Facility Name
Allergy and Clinical Immunology Associates
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James DeAngelo
Facility Name
National Allergy and Asthma Research, LLC.
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29420
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Ramey
Facility Name
Innovaderm Research Inc.
City
Montréal
ZIP/Postal Code
H2X 2V1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Etienne Saint-Cyr
Facility Name
Gordon Sussman Clinical Research Inc.
City
North York
ZIP/Postal Code
M3B 3S6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gordon Sussman
12. IPD Sharing Statement
Learn more about this trial
Phase 1b, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of EP262 in Subjects With Chronic Inducible Urticaria
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