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

Chronic Spontaneous Urticaria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05373355
• Other study ID #: TLL018-204
• Status: Completed
• Phase: Phase 1
• Start date: May 10, 2022
• Est. completion date: September 7, 2023

Study information

• Verified date: October 2023
• Source: Hangzhou Highlightll Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: September 7, 2023
• Est. primary completion date: September 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Spontaneous Urticaria
• Chronic Urticaria
• Urticaria

Intervention

Drug:
• TLL018 tablets
Oral tablets administered at different doses BID daily for 12 weeks.

Locations

Country	Name	City	State
China	Hospital For Skin Diseases,Institute of Dermatology Chinese Academy of Medical Sciences, Peking Union Medical College	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Hangzhou Highlightll Pharmaceutical Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	adverse events (AEs) according to severity	Number of adverse events (AEs) according to severity	From day 1 to Weeks 4
Primary	blood pressure from baseline	Change of blood pressure from baseline	From day 1 to Weeks 4
Primary	pulse rate from baseline	Change of pulse rate from baseline	From day 1 to Weeks 4
Primary	respiratory rate from baseline	Change of respiratory rate from baseline	From day 1 to Weeks 4
Primary	temperature from baseline	Change of oral temperature from baseline	From day 1 to Weeks 4
Primary	clinical laboratory abnormalities compared to baseline	Number of participants with clinical laboratory abnormalities compared to baseline	From day 1 to Weeks 4
Primary	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
Primary	physical examination findings from baseline	Number of participants with changes in physical examination findings from baseline	From day 1 to Weeks 4
Primary	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	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
Secondary	adverse events (AEs) according to severity	Number of adverse events (AEs) according to severity	From week 4 to Weeks 12
Secondary	blood pressure from baseline	Change of blood pressure from baseline	From week 4 to Weeks 12
Secondary	pulse rate from baseline	Change of pulse rate from baseline	From week 4 to Weeks 12
Secondary	respiratory rate from baseline	Change of respiratory rate from baseline	From week 4 to Weeks 12
Secondary	temperature from baseline	Change of oral temperature from baseline	From week 4 to Weeks 12
Secondary	clinical laboratory abnormalities compared to baseline	Number of participants with clinical laboratory abnormalities compared to baseline	From week 4 to Weeks 12
Secondary	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
Secondary	physical examination findings from baseline	Number of participants with changes in physical examination findings from baseline	From week 4 to Weeks 12
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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