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

Primary Purpose

Chronic Spontaneous Urticaria

Status
Active
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
TLL018 tablets
Sponsored by
Hangzhou Highlightll Pharmaceutical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Spontaneous Urticaria

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Cohort 1

Cohort 2

Cohort 3

Arm Description

TLL018 tablets 1piece,BID

TLL018 tablets 3pieces, BID

TLL018 placeboes 3pieces, BID

Outcomes

Primary Outcome Measures

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
adverse events (AEs) according to severity
Number of adverse events (AEs) according to severity
blood pressure from baseline
Change of blood pressure from baseline
pulse rate from baseline
Change of pulse rate from baseline
respiratory rate from baseline
Change of respiratory rate from baseline
temperature from baseline
Change of oral temperature from baseline
clinical laboratory abnormalities compared to baseline
Number of participants with clinical laboratory abnormalities compared to baseline
ECG parameters from baseline
Change in 12-lead electrocardiogram (ECG) parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) from baseline
physical examination findings from baseline
Number of participants with changes in physical examination findings from baseline
Cmax of TLL018
Maximum observed plasma concentration (Cmax) of TLL018

Secondary Outcome Measures

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
adverse events (AEs) according to severity
Number of adverse events (AEs) according to severity
blood pressure from baseline
Change of blood pressure from baseline
pulse rate from baseline
Change of pulse rate from baseline
respiratory rate from baseline
Change of respiratory rate from baseline
temperature from baseline
Change of oral temperature from baseline
clinical laboratory abnormalities compared to baseline
Number of participants with clinical laboratory abnormalities compared to baseline
ECG parameters from baseline
Change in 12-lead electrocardiogram (ECG) parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) from baseline
physical examination findings from baseline
Number of participants with changes in physical examination findings from baseline
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
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
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
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
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
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

Full Information

First Posted
May 10, 2022
Last Updated
July 1, 2023
Sponsor
Hangzhou Highlightll Pharmaceutical Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05373355
Brief Title
Safety and Efficacy of TLL018 in Patients With Chronic Spontaneous Urticaria.
Official Title
Safety and Efficacy of TLL018 in Patients With Chronic Spontaneous Urticaria.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 10, 2022 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hangzhou Highlightll Pharmaceutical Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Spontaneous Urticaria

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
TLL018 tablets 1piece,BID
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
TLL018 tablets 3pieces, BID
Arm Title
Cohort 3
Arm Type
Placebo Comparator
Arm Description
TLL018 placeboes 3pieces, BID
Intervention Type
Drug
Intervention Name(s)
TLL018 tablets
Other Intervention Name(s)
TLL018 Placeboes
Intervention Description
Oral tablets administered at different doses BID daily for 12 weeks.
Primary Outcome Measure Information:
Title
treatment-emergent adverse events (AEs), serious adverse events (SAEs) and discontinuation due to AEs/SAEs
Description
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
Title
adverse events (AEs) according to severity
Description
Number of adverse events (AEs) according to severity
Time Frame
From day 1 to Weeks 4
Title
blood pressure from baseline
Description
Change of blood pressure from baseline
Time Frame
From day 1 to Weeks 4
Title
pulse rate from baseline
Description
Change of pulse rate from baseline
Time Frame
From day 1 to Weeks 4
Title
respiratory rate from baseline
Description
Change of respiratory rate from baseline
Time Frame
From day 1 to Weeks 4
Title
temperature from baseline
Description
Change of oral temperature from baseline
Time Frame
From day 1 to Weeks 4
Title
clinical laboratory abnormalities compared to baseline
Description
Number of participants with clinical laboratory abnormalities compared to baseline
Time Frame
From day 1 to Weeks 4
Title
ECG parameters from baseline
Description
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
Title
physical examination findings from baseline
Description
Number of participants with changes in physical examination findings from baseline
Time Frame
From day 1 to Weeks 4
Title
Cmax of TLL018
Description
Maximum observed plasma concentration (Cmax) of TLL018
Time Frame
0 hour (pre-dose - within 30 minutes prior to dosing), and at 0.5, 1, 2, 4 and 8 hours post-dose
Secondary Outcome Measure Information:
Title
treatment-emergent adverse events (AEs), serious adverse events (SAEs) and discontinuation due to AEs/SAEs
Description
Number of participants with treatment-emergent adverse events (AEs), serious adverse events (SAEs) and discontinuation due to AEs/SAEs
Time Frame
From week 4 to Weeks 12
Title
adverse events (AEs) according to severity
Description
Number of adverse events (AEs) according to severity
Time Frame
From week 4 to Weeks 12
Title
blood pressure from baseline
Description
Change of blood pressure from baseline
Time Frame
From week 4 to Weeks 12
Title
pulse rate from baseline
Description
Change of pulse rate from baseline
Time Frame
From week 4 to Weeks 12
Title
respiratory rate from baseline
Description
Change of respiratory rate from baseline
Time Frame
From week 4 to Weeks 12
Title
temperature from baseline
Description
Change of oral temperature from baseline
Time Frame
From week 4 to Weeks 12
Title
clinical laboratory abnormalities compared to baseline
Description
Number of participants with clinical laboratory abnormalities compared to baseline
Time Frame
From week 4 to Weeks 12
Title
ECG parameters from baseline
Description
Change in 12-lead electrocardiogram (ECG) parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) from baseline
Time Frame
From week 4 to Weeks 12
Title
physical examination findings from baseline
Description
Number of participants with changes in physical examination findings from baseline
Time Frame
From week 4 to Weeks 12
Title
UAS7 score decreased from baseline at week 4
Description
Change in mean value of UAS7 score from baseline at week 4 when comparing TLL-018 with placebo
Time Frame
Baseline to Week 4
Title
UAS7 score decreased from baseline at week 8
Description
Change in mean value of UAS7 score from baseline at week 8 when comparing TLL-018 with placebo
Time Frame
Time Frame: Baseline to Week 8
Title
UAS7 score decreased from baseline at week 12
Description
Change in mean value of UAS7 score from baseline at week 12 when comparing TLL-018 with placebo
Time Frame
Baseline to Week 12
Title
DLQI score decreased from baseline at week 4
Description
Change in mean value of DLQI score from baseline at week 4 when comparing TLL-018 with placebo
Time Frame
Baseline to Weeks 4
Title
DLQI score decreased from baseline at week 8
Description
Change in mean value of DLQI score from baseline at week 8 when comparing TLL-018 with placebo
Time Frame
Baseline to Weeks 8
Title
DLQI score decreased from baseline at week 12
Description
Change in mean value of DLQI score from baseline at week 12 when comparing TLL-018 with placebo
Time Frame
Baseline to Weeks 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Hospital For Skin Diseases,Institute of Dermatology Chinese Academy of Medical Sciences, Peking Union Medical College
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210042
Country
China

12. IPD Sharing Statement

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

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