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

• Sponsor: Escient Pharmaceuticals, Inc (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT06050928
• Collaborator: (none)
• Enrollment: 30
• Locations: 6
• Arm: 1
• Anticipated Duration (Months): 14
• Patients Per Site: 5
• Patients Per Site Per Month: 0.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Inducible Urticaria	Drug: Oral EP262	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase 1b, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of EP262 in Subjects With Chronic Inducible Urticaria (CALM-CIndU)
• Anticipated Study Start Date: Sep 1, 2023
• Anticipated Primary Completion Date: Sep 1, 2024
• Anticipated Study Completion Date: Nov 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EP262 150 mg Once daily	Drug: Oral EP262; Once daily

Outcome Measures

Primary Outcome Measures

1. Safety and tolerability of EP262 [Measured from Day 1 to End of Study or Early Termination (up to 12 weeks)]

   Assessed by the incidence of treatment-emergent adverse events

Secondary Outcome Measures

1. Change in Critical Friction Threshold (CFT) [Measured from Baseline to Week 4]

   Assessed by the number of prongs that elicit a wheal response using a FricTest (in subjects with symptomatic dermographism)

2. Change in Critical Temperature Threshold (CTT) [Measured from Baseline to Week 4]

   Assessed as the highest temperature that elicits a wheal response using a TempTest (in subjects with cold urticaria)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Advanced Clinical Research Institute	Tampa	Florida	United States	33607
2	Treasure Valley Medical Research	Boise	Idaho	United States	83706
3	Allergy and Clinical Immunology Associates	Pittsburgh	Pennsylvania	United States	15241
4	National Allergy and Asthma Research, LLC.	North Charleston	South Carolina	United States	29420
5	Innovaderm Research Inc.	Montréal		Canada	H2X 2V1
6	Gordon Sussman Clinical Research Inc.	North York		Canada	M3B 3S6

Sponsors and Collaborators

• Escient Pharmaceuticals, Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Escient Pharmaceuticals, Inc
• ClinicalTrials.gov Identifier: NCT06050928
• Other Study ID Numbers: EP-262-102
• First Posted: Sep 22, 2023
• Last Update Posted: Sep 22, 2023
• Last Verified: Sep 1, 2023

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Urticaria; Chronic Inducible Urticaria

Study Results

No Results Posted as of Sep 22, 2023