Safety and Efficacy of TLL018 in Patients With Chronic Spontaneous Urticaria.

Safety and Efficacy of TLL018 in Patients With Chronic Spontaneous Urticaria.

This study is a randomized, double-blind, placebo-controlled, multicenter clinical trial of about 36 subjects with moderate to severe Chronic Spontaneous Urticaria.

Successfully screened subjects will be randomized in a ratio of 1：1：1. After a 4-week screening period (day -28-0), subjects will be randomly assigned to treatment for 12 weeks.

Clinical Urticaria Activity Score (UAS), dermatological Quality of Life Index (DLQI), physical exams and Laboratory tests will be performed at baseline, the end of weeks 4, 8 and 12 respectively.

Inclusion Criteria:

• Have had a diagnosis of moderate to severe Chronic Spontaneous Urticaria for at least 6 months prior to Baseline;
• Subjects with moderate to severe Chronic Spontaneous Urticaria UAS7 score ≥16 at Baseline;
• Able and willing to give written informed consent.

Exclusion Criteria:

• Other types of Chronic Urticaria (such as Artificial urticaria, cold-contact urticaria, heat-contact urticaria etc);
• Other disease with symptoms of urticaria or angioedema, e.g., Urticaria vasculitis, color Vegetarian urticaria, erythema multiforme;
• History or symptoms of malignancy in any organ system regardless of treatment, and regardless of evidence of recurrence or metastasis;
• Any uncontrolled clinically significant laboratory abnormality that would affect interpretation of study data or the subject's participation in the study.