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Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects With Chronic Spontaneous Urticaria (CALM-CSU)

Primary Purpose

Chronic Spontaneous Urticaria

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Oral EP262
Placebo
Sponsored by
Escient Pharmaceuticals, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Spontaneous Urticaria focused on measuring Chronic Spontaneous Urticaria, Chronic Urticaria, Urticaria, EP262, CALM-CSU, CALM

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Documented history of chronic spontaneous urticaria (CSU) with a UAS7 greater than or equal to 16 despite stable treatment with H1 antihistamine consistent with standard of care Must be on a stable dose of H1 antihistamine up to 4 times the approved dose per local treatment guidelines Exclusion Criteria: Urticaria with a clear underlying etiology other than CSU Urticaria with a clearly defined or sole trigger (chronic inducible urticaria) Other active skin diseases associated with chronic pruritus (eg, atopic dermatitis, bullous pemphigoid, prurigo nodularis, dermatitis herpetiformis)

Sites / Locations

  • AllerVie Clinical ResearchRecruiting
  • Antelope Valley Clinical TrialsRecruiting
  • Advanced Clinical Research InstituteRecruiting
  • Treasure Valley Medical ResearchRecruiting
  • Chesapeake Clinical Research, Inc.Recruiting
  • Vital Prospects Clinical Research Institute, PCRecruiting
  • National Allergy and Asthma Research, LLC.Recruiting
  • Gordon Sussman Clinical ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

EP262 50 mg

EP262 150 mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change in Urticaria Activity Score (UAS) over a 7-day period (UAS7)
Assessed using the UAS7 measuring the intensity of itch and number of hives over the past 7 days

Secondary Outcome Measures

Safety and tolerability of EP262
Assessed by the incidence of treatment-emergent adverse events
Change in Itch Severity Score (ISS) over a 7-day period (ISS7)
Assessed using the ISS7 measuring the intensity of itch over the past 7 days
Change in Hive Severity Score (HSS) over a 7-day period (HSS7)
Assessed using the HSS7 measuring the number of hives over the past 7 days

Full Information

First Posted
October 5, 2023
Last Updated
October 5, 2023
Sponsor
Escient Pharmaceuticals, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT06077773
Brief Title
Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects With Chronic Spontaneous Urticaria
Acronym
CALM-CSU
Official Title
Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects With Chronic Spontaneous Urticaria (CALM-CSU)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
October 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
Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects with Chronic Spontaneous Urticaria

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Spontaneous Urticaria
Keywords
Chronic Spontaneous Urticaria, Chronic Urticaria, Urticaria, EP262, CALM-CSU, CALM

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EP262 50 mg
Arm Type
Experimental
Arm Title
EP262 150 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Oral EP262
Intervention Description
Once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Once daily
Primary Outcome Measure Information:
Title
Change in Urticaria Activity Score (UAS) over a 7-day period (UAS7)
Description
Assessed using the UAS7 measuring the intensity of itch and number of hives over the past 7 days
Time Frame
Measured from Baseline to Week 6
Secondary 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 10 weeks)
Title
Change in Itch Severity Score (ISS) over a 7-day period (ISS7)
Description
Assessed using the ISS7 measuring the intensity of itch over the past 7 days
Time Frame
Measured from Baseline to Week 6
Title
Change in Hive Severity Score (HSS) over a 7-day period (HSS7)
Description
Assessed using the HSS7 measuring the number of hives over the past 7 days
Time Frame
Measured from Baseline to Week 6

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: Documented history of chronic spontaneous urticaria (CSU) with a UAS7 greater than or equal to 16 despite stable treatment with H1 antihistamine consistent with standard of care Must be on a stable dose of H1 antihistamine up to 4 times the approved dose per local treatment guidelines Exclusion Criteria: Urticaria with a clear underlying etiology other than CSU Urticaria with a clearly defined or sole trigger (chronic inducible urticaria) Other active skin diseases associated with chronic pruritus (eg, atopic dermatitis, bullous pemphigoid, prurigo nodularis, dermatitis herpetiformis)
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
AllerVie Clinical Research
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weily Soong
Facility Name
Antelope Valley Clinical Trials
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ricardo Tan
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
Chesapeake Clinical Research, Inc.
City
White Marsh
State/Province
Maryland
ZIP/Postal Code
21162
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Matz
Facility Name
Vital Prospects Clinical Research Institute, PC
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iftikhar Hussain
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
Gordon Sussman Clinical Research
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

Plan to Share IPD
Undecided

Learn more about this trial

Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects With Chronic Spontaneous Urticaria

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