Phase 2b Study of EVO756 in Adults With Moderate to Severe Chronic Spontaneous Urticaria (CSU)

Evommune

Status and phase: Enrolling; Phase 2

Conditions: Chronic Spontaneous Urticaria

Treatments: Drug: EVO756; Drug: Placebo control

Study type: Interventional

Funder types: Industry

Identifiers

NCT06873516

EVO756-CSU001

Details and patient eligibility

About

This study will evaluate the efficacy and safety of different doses of EVO756 in adults with moderate to severe chronic spontaneous urticaria (CSU).

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed CSU diagnosis for at least 3 months with an inadequate response to H1-antihistamines.
• Subjects who are taking H1-antihistamines must be on a stable regimen 4 weeks prior to Day 1 and while on study.
• Urticaria Activity Score (UAS7) equal to or greater than 16 at Day 1. UAS entries must be completed for a minimum of 4 out of the 7 days prior to Day 1.

Exclusion criteria

• Any clinically significant abnormality in laboratory evaluations, physical examinations, vital signs, or ECG at Screening, according to the Investigator's discretion.
• Use of certain medications.
• History of diseases with urticaria or angioedema symptoms, other than CSU and symptomatic dermographism.
• Significant medical history other than CSU, or any other condition which might interfere with the evaluation of CSU.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 4 patient groups, including a placebo group

Dose 1

Experimental group

Description:

Orally administered EVO756, dose 1

Treatment:

Drug: EVO756

Drug: EVO756

Drug: EVO756

Dose 2

Experimental group

Description:

Orally administered EVO756, dose 2

Treatment:

Drug: EVO756

Drug: EVO756

Drug: EVO756

Dose 3

Experimental group

Description:

Orally administered EVO756, dose 3

Treatment:

Drug: EVO756

Drug: EVO756

Drug: EVO756

Placebo control

Placebo Comparator group

Description:

Orally administered placebo control

Treatment:

Drug: Placebo control