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

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

Study Overview

• Status: Completed
• Conditions: Chronic Spontaneous Urticaria
• Intervention / Treatment: Drug: TLL018 tablets

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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210042
      • Hospital For Skin Diseases,Institute of Dermatology Chinese Academy of Medical Sciences, Peking Union Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; TLL018 tablets 1piece,BID	Drug: TLL018 tablets; Oral tablets administered at different doses BID daily for 12 weeks.; Other Names: TLL018 Placeboes
Experimental: Cohort 2; TLL018 tablets 3pieces, BID	Drug: TLL018 tablets; Oral tablets administered at different doses BID daily for 12 weeks.; Other Names: TLL018 Placeboes
Placebo Comparator: Cohort 3; TLL018 placeboes 3pieces, BID	Drug: TLL018 tablets; Oral tablets administered at different doses BID daily for 12 weeks.; Other Names: TLL018 Placeboes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From day 1 to Weeks 4
adverse events (AEs) according to severity	Number of adverse events (AEs) according to severity	From day 1 to Weeks 4
blood pressure from baseline	Change of blood pressure from baseline	From day 1 to Weeks 4
pulse rate from baseline	Change of pulse rate from baseline	From day 1 to Weeks 4
respiratory rate from baseline	Change of respiratory rate from baseline	From day 1 to Weeks 4
temperature from baseline	Change of oral temperature from baseline	From day 1 to Weeks 4
clinical laboratory abnormalities compared to baseline	Number of participants with clinical laboratory abnormalities compared to baseline	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	From day 1 to Weeks 4
physical examination findings from baseline	Number of participants with changes in physical examination findings from baseline	From day 1 to Weeks 4
Cmax of TLL018	Maximum observed plasma concentration (Cmax) of TLL018	0 hour (pre-dose - within 30 minutes prior to dosing), and at 0.5, 1, 2, 4 and 8 hours post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From week 4 to Weeks 12
adverse events (AEs) according to severity	Number of adverse events (AEs) according to severity	From week 4 to Weeks 12
blood pressure from baseline	Change of blood pressure from baseline	From week 4 to Weeks 12
pulse rate from baseline	Change of pulse rate from baseline	From week 4 to Weeks 12
respiratory rate from baseline	Change of respiratory rate from baseline	From week 4 to Weeks 12
temperature from baseline	Change of oral temperature from baseline	From week 4 to Weeks 12
clinical laboratory abnormalities compared to baseline	Number of participants with clinical laboratory abnormalities compared to baseline	From week 4 to Weeks 12
ECG parameters from baseline	Change in 12-lead electrocardiogram (ECG) parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) from baseline	From week 4 to Weeks 12
physical examination findings from baseline	Number of participants with changes in physical examination findings from baseline	From week 4 to Weeks 12
UAS7 score decreased from baseline at week 4	Change in mean value of UAS7 score from baseline at week 4 when comparing TLL-018 with placebo	Baseline to Week 4
UAS7 score decreased from baseline at week 8	Change in mean value of UAS7 score from baseline at week 8 when comparing TLL-018 with placebo	Time Frame: Baseline to Week 8
UAS7 score decreased from baseline at week 12	Change in mean value of UAS7 score from baseline at week 12 when comparing TLL-018 with placebo	Baseline to Week 12
DLQI score decreased from baseline at week 4	Change in mean value of DLQI score from baseline at week 4 when comparing TLL-018 with placebo	Baseline to Weeks 4
DLQI score decreased from baseline at week 8	Change in mean value of DLQI score from baseline at week 8 when comparing TLL-018 with placebo	Baseline to Weeks 8
DLQI score decreased from baseline at week 12	Change in mean value of DLQI score from baseline at week 12 when comparing TLL-018 with placebo	Baseline to Weeks 12

Collaborators and Investigators

• Sponsor: Hangzhou Highlightll Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2022
• Primary Completion (Actual): September 7, 2023
• Study Completion (Actual): September 7, 2023

Study Registration Dates

• First Submitted: May 10, 2022
• First Submitted That Met QC Criteria: May 10, 2022
• First Posted (Actual): May 13, 2022

Study Record Updates

• Last Update Posted (Estimated): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Disease Attributes; Skin Diseases, Vascular; Hypersensitivity; Chronic Disease; Urticaria; Chronic Urticaria
• Other Study ID Numbers: TLL018-204

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No