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

Phase 2

Terminated

• Conditions: Chronic Spontaneous Urticaria
• Interventions: Drug: Oral EP262; Drug: Placebo

• Registration Number: NCT06077773
• Lead Sponsor: Escient Pharmaceuticals, Inc

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-25
• Study First Submitted: 2023-10-05
• Study First Submitted QC: 2023-10-05
• Study First Posted: 2023-10-11
• Primary Completion: 2024-12-18
• Study Completion: 2025-01-16
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 113

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EP262 50 mg	Oral EP262	-
EP262 150 mg	Oral EP262	-
Placebo	Placebo	-
EP262 25 mg	Oral EP262	-

Primary Outcome Measures

Name	Time	Method
Change in Urticaria Activity Score (UAS) over a 7-day period (UAS7)	Measured from Baseline to Week 6	Assessed using the UAS7 measuring the intensity of itch and number of hives over the past 7 days

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability of EP262	Measured from Day 1 to End of Study or Early Termination (up to 10 weeks)	Assessed by the incidence of treatment-emergent adverse events
Change in Itch Severity Score (ISS) over a 7-day period (ISS7)	Measured from Baseline to Week 6	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)	Measured from Baseline to Week 6	Assessed using the HSS7 measuring the number of hives over the past 7 days

Trial Locations

Locations (48)

AllerVie Clinical Research; 🇺🇸 Birmingham, Alabama, United States

Scottsdale Clinical Trials; 🇺🇸 Scottsdale, Arizona, United States

Little Rock Allergy & Asthma Clinical Research Center; 🇺🇸 Little Rock, Arkansas, United States

First OC Dermatology Research, Inc.; 🇺🇸 Fountain Valley, California, United States

Allergy and Asthma Specialists Medical Group; 🇺🇸 Huntington Beach, California, United States

Antelope Valley Clinical Trials; 🇺🇸 Los Angeles, California, United States

Allervie Clinical Research; 🇺🇸 Destin, Florida, United States

University of Miami Itch Center; 🇺🇸 Miami, Florida, United States

Florida Center for Allergy and Asthma Research; 🇺🇸 Miami, Florida, United States

NuLine Clinical Trial Center; 🇺🇸 Pompano Beach, Florida, United States

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