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

Escient Pharmaceuticals

Status and phase: Enrolling; Phase 2

Conditions: Chronic Spontaneous Urticaria

Treatments: Drug: Placebo; Drug: Oral EP262

Study type: Interventional

Funder types: Industry

Identifiers

NCT06077773

EP-262-201

Details and patient eligibility

About

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

Enrollment: 154 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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154 participants in 4 patient groups, including a placebo group

EP262 50 mg

Experimental group

Treatment:

Drug: Oral EP262

EP262 150 mg

Experimental group

Treatment:

Drug: Oral EP262

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

EP262 25 mg

Experimental group

Treatment:

Drug: Oral EP262