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

A Randomized, Double-Blind, Placebo Controlled, Dose-Ranging Study Evaluating the Efficacy and Safety of EVO756 in Adults With Moderate to Severe Chronic Spontaneous Urticaria

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06873516

Enrollment

182

Registered

2025-03-12

Start date

2025-03-20

Completion date

2026-06-05

Last updated

2026-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Spontaneous Urticaria

Keywords

chronic spontaneous urticaria, CSU, chronic hives, hives, idiopathic urticaria, urticaria

Brief summary

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

Interventions

DRUGEVO756

Dose 1

DRUGPlacebo control

Placebo control

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Mean change from baseline in UAS7	Week 12

Secondary

Measure	Time frame
Percent change from baseline in UAS7	Week 12
Mean and percent change from baseline in UAS7	Weeks 1, 2, 4, 8
Mean and percent change from baseline in ISS7	Weeks 1, 2, 4, 8, 12
Mean and percent change from baseline in HSS7	Weeks 1, 2, 4, 8, 12
Mean and percent change from baseline in AAS7	Weeks 1, 2, 4, 8, 12
Proportion of subjects achieving UAS7 ≤ 6	Weeks 1, 2, 4, 8, 12
Proportion of subjects achieving UAS7 = 0	Weeks 1, 2, 4, 8, 12

Countries

Canada, Japan, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 2, 2026