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

NCT ID: NCT05373355

Last Updated: 2024-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-10
• Study Completion Date: 2023-09-07

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 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.

Conditions

Chronic Spontaneous Urticaria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Cohort 1

TLL018 tablets 1piece,BID

Group Type: EXPERIMENTAL

TLL018 tablets

Intervention Type: DRUG

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

Cohort 2

TLL018 tablets 3pieces, BID

Group Type: EXPERIMENTAL

TLL018 tablets

Intervention Type: DRUG

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

Cohort 3

TLL018 placeboes 3pieces, BID

Group Type: PLACEBO_COMPARATOR

TLL018 tablets

Intervention Type: DRUG

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

Interventions

TLL018 tablets

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

Intervention Type: DRUG

Other Intervention Names

TLL018 Placeboes

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hangzhou Highlightll Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

TLL018-204

Identifier Type: -

Identifier Source: org_study_id