Status:
COMPLETED
Safety and Efficacy of TLL018 in Patients With Chronic Spontaneous Urticaria.
Lead Sponsor:
Hangzhou Highlightll Pharmaceutical Co., Ltd
Conditions:
Chronic Spontaneous Urticaria
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
This study is a randomized, double-blind, placebo-controlled, multicenter clinical trial of about 36 subjects with moderate to severe Chronic Spontaneous Urticaria.
Detailed Description
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 Ac...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 7 2023
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT05373355
Start Date
May 10 2022
End Date
September 7 2023
Last Update
March 1 2024
Active Locations (1)
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1
Hospital For Skin Diseases,Institute of Dermatology Chinese Academy of Medical Sciences, Peking Union Medical College
Nanjing, Jiangsu, China, 210042