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

Hangzhou Highlightll Pharmaceutical Co., Ltd41 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Chronic Spontaneous Urticaria

Interventions

TLL018 tabletsDRUG

Oral tablets administered at different doses BID daily for 12 weeks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital For Skin Diseases,Institute of Dermatology Chinese Academy of Medical Sciences, Peking Union Medical College

Nanjing, Jiangsu, China

Outcomes

Primary Outcomes

treatment-emergent adverse events (AEs), serious adverse events (SAEs) and discontinuation due to AEs/SAEs

Number of participants with treatment-emergent adverse events (AEs), serious adverse events (SAEs) and discontinuation due to AEs/SAEs

Time frame: From day 1 to Weeks 4

adverse events (AEs) according to severity

Number of adverse events (AEs) according to severity

Time frame: From day 1 to Weeks 4

blood pressure from baseline

Change of blood pressure from baseline

Time frame: From day 1 to Weeks 4

pulse rate from baseline

Change of pulse rate from baseline

Time frame: From day 1 to Weeks 4

respiratory rate from baseline

Change of respiratory rate from baseline

Time frame: From day 1 to Weeks 4

temperature from baseline

Change of oral temperature from baseline

Time frame: From day 1 to Weeks 4

clinical laboratory abnormalities compared to baseline

Number of participants with clinical laboratory abnormalities compared to baseline

Time frame: From day 1 to Weeks 4

ECG parameters from baseline

Change in 12-lead electrocardiogram (ECG) parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) from baseline

Time frame: From day 1 to Weeks 4

Data from ClinicalTrials.gov

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Secondary Outcomes

treatment-emergent adverse events (AEs), serious adverse events (SAEs) and discontinuation due to AEs/SAEs

Number of participants with treatment-emergent adverse events (AEs), serious adverse events (SAEs) and discontinuation due to AEs/SAEs