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

• Status: Not yet recruiting
• Trial end date: 2022-12-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hangzhou Highlightll Pharmaceutical Co., Ltd

Criteria

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.