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

Hangzhou Highlightll Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Chronic Spontaneous Urticaria

Treatments: Drug: TLL018 tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT05373355

TLL018-204

Details and patient eligibility

About

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

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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41 participants in 3 patient groups, including a placebo group

Cohort 1

Experimental group

Description:

TLL018 tablets 1piece,BID

Treatment:

Drug: TLL018 tablets

Cohort 2

Experimental group

Description:

TLL018 tablets 3pieces, BID

Treatment:

Drug: TLL018 tablets

Cohort 3

Placebo Comparator group

Description:

TLL018 placeboes 3pieces, BID

Treatment:

Drug: TLL018 tablets