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

February 29, 2024 updated by: Hangzhou Highlightll Pharmaceutical Co., Ltd
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
41

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
treatment-emergent adverse events (AEs), serious adverse events (SAEs) and discontinuation due to AEs/SAEs
Time Frame: From day 1 to Weeks 4
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
Time Frame: From day 1 to Weeks 4
Number of adverse events (AEs) according to severity
From day 1 to Weeks 4
blood pressure from baseline
Time Frame: From day 1 to Weeks 4
Change of blood pressure from baseline
From day 1 to Weeks 4
pulse rate from baseline
Time Frame: From day 1 to Weeks 4
Change of pulse rate from baseline
From day 1 to Weeks 4
respiratory rate from baseline
Time Frame: From day 1 to Weeks 4
Change of respiratory rate from baseline
From day 1 to Weeks 4
temperature from baseline
Time Frame: From day 1 to Weeks 4
Change of oral temperature from baseline
From day 1 to Weeks 4
clinical laboratory abnormalities compared to baseline
Time Frame: From day 1 to Weeks 4
Number of participants with clinical laboratory abnormalities compared to baseline
From day 1 to Weeks 4
ECG parameters from baseline
Time Frame: From day 1 to Weeks 4
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
Time Frame: From day 1 to Weeks 4
Number of participants with changes in physical examination findings from baseline
From day 1 to Weeks 4
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
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
treatment-emergent adverse events (AEs), serious adverse events (SAEs) and discontinuation due to AEs/SAEs
Time Frame: From week 4 to Weeks 12
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
Time Frame: From week 4 to Weeks 12
Number of adverse events (AEs) according to severity
From week 4 to Weeks 12
blood pressure from baseline
Time Frame: From week 4 to Weeks 12
Change of blood pressure from baseline
From week 4 to Weeks 12
pulse rate from baseline
Time Frame: From week 4 to Weeks 12
Change of pulse rate from baseline
From week 4 to Weeks 12
respiratory rate from baseline
Time Frame: From week 4 to Weeks 12
Change of respiratory rate from baseline
From week 4 to Weeks 12
temperature from baseline
Time Frame: From week 4 to Weeks 12
Change of oral temperature from baseline
From week 4 to Weeks 12
clinical laboratory abnormalities compared to baseline
Time Frame: From week 4 to Weeks 12
Number of participants with clinical laboratory abnormalities compared to baseline
From week 4 to Weeks 12
ECG parameters from baseline
Time Frame: From week 4 to Weeks 12
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
Time Frame: From week 4 to Weeks 12
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
Time Frame: Baseline to 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
Time Frame: Time Frame: Baseline to 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
Time Frame: Baseline to 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
Time Frame: Baseline to Weeks 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
Time Frame: Baseline to Weeks 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
Time Frame: Baseline to Weeks 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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hangzhou Highlightll Pharmaceutical Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 10, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 7, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 7, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 10, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 13, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 1, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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