Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects With Chronic Spontaneous Urticaria (CALM-CSU)
Overview
- Phase
- Phase 2
- Intervention
- Oral EP262
- Conditions
- Chronic Spontaneous Urticaria
- Sponsor
- Escient Pharmaceuticals, Inc
- Enrollment
- 113
- Locations
- 48
- Primary Endpoint
- Change From Baseline to Visit 4 (Week 6) in the Urticaria Activity Score Over a 7-day Period (UAS7)
- Status
- Terminated
- Last Updated
- 4 months ago
Overview
Brief Summary
Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects with Chronic Spontaneous Urticaria
Investigators
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)
Arms & Interventions
EP262 50 mg
Intervention: Oral EP262
EP262 150 mg
Intervention: Oral EP262
Placebo
Intervention: Placebo
EP262 25 mg
Intervention: Oral EP262
Outcomes
Primary Outcomes
Change From Baseline to Visit 4 (Week 6) in the Urticaria Activity Score Over a 7-day Period (UAS7)
Time Frame: Baseline; Week 6
The UAS is a chronic spontaneous urticaria (CSU)-specific, 24-hour self-evaluation, patient-reported outcome measure based on the assessment of key CSU symptoms: intensity of itch (assessed as the Itch Severity Score \[ISS\]) and number of wheals (assessed as the Hive Severity Score \[HSS\]). The UAS scales for both itch and wheal assessment are recorded as a score from 0 to 3, with 0 representing no itch/hives to 3 representing intense itch/hives. ISS and HSS scores are summed over 7 consecutive days to create the ISS7 and HSS7 scores, which range from 0 to 21. Higher scores indicate greater disease severity. The UAS score is the sum of the ISS and HSS scores. Daily UAS scores are summed over 7 consecutive days to create the UAS7 score, which ranges from 0 to 42. Higher scores indicate greater disease severity. The 7 daily UAS/ISS/HSS scores prior to or on the nominal Visit 4 (Week 6) date (including the nominal Week 6 visit date UAS/ISS/HSS score) were summed.
Secondary Outcomes
- Number of Participants With Any Treatment-emergent Adverse Event (TEAE)(up to 81 days)
- Number of Participants With Any ≥Grade 3 TEAE(up to 81 days)
- Number of Participants With Any Clinically Meaningful Change From Baseline in Electrocardiogram Parameters(up to 81 days)
- Number of Participants With Any Clinically Meaningful Change From Baseline in Vital Sign Measurements(up to 81 days)
- Number of Participants With Any Clinically Meaningful Change From Baseline in Clinical Laboratory Test Results(up to 81 days)
- Change From Baseline to Visit 4 (Week 6) in the Itch Severity Score Over a 7-day Period (ISS7)(Baseline; Week 6)
- Change From Baseline to Visit 4 (Week 6) in the Hive Severity Score Over a 7-day Period (HSS7)(Baseline; Week 6)