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Completed

NCT Number: NCT05373355

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.

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Key information

Conditions

Chronic Spontaneous Urticaria Chronic Disease Chronic Urticaria Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Nanjing, Jiangsu, 210042, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TLL018 tablets

Drug

Oral tablets administered at different doses BID daily for 12 weeks.

Other names: TLL018 Placeboes

Primary outcomes

  1. 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

  2. adverse events (AEs) according to severity

    Time frame: From day 1 to Weeks 4

    Number of adverse events (AEs) according to severity

  3. blood pressure from baseline

    Time frame: From day 1 to Weeks 4

    Change of blood pressure from baseline

  4. pulse rate from baseline

    Time frame: From day 1 to Weeks 4

    Change of pulse rate from baseline

  5. respiratory rate from baseline

    Time frame: From day 1 to Weeks 4

    Change of respiratory rate from baseline

  6. temperature from baseline

    Time frame: From day 1 to Weeks 4

    Change of oral temperature from baseline

  7. clinical laboratory abnormalities compared to baseline

    Time frame: From day 1 to Weeks 4

    Number of participants with clinical laboratory abnormalities compared to baseline

  8. 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

  9. physical examination findings from baseline

    Time frame: From day 1 to Weeks 4

    Number of participants with changes in physical examination findings from baseline

  10. 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

Secondary outcomes

  1. 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

  2. adverse events (AEs) according to severity

    Time frame: From week 4 to Weeks 12

    Number of adverse events (AEs) according to severity

  3. blood pressure from baseline

    Time frame: From week 4 to Weeks 12

    Change of blood pressure from baseline

  4. pulse rate from baseline

    Time frame: From week 4 to Weeks 12

    Change of pulse rate from baseline

  5. respiratory rate from baseline

    Time frame: From week 4 to Weeks 12

    Change of respiratory rate from baseline

  6. temperature from baseline

    Time frame: From week 4 to Weeks 12

    Change of oral temperature from baseline

  7. clinical laboratory abnormalities compared to baseline

    Time frame: From week 4 to Weeks 12

    Number of participants with clinical laboratory abnormalities compared to baseline

  8. 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

  9. physical examination findings from baseline

    Time frame: From week 4 to Weeks 12

    Number of participants with changes in physical examination findings from baseline

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

Sponsors and collaborators

Lead sponsor

Hangzhou Highlightll Pharmaceutical Co., Ltd

Industry

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 13, 2022
Registry last updated
Mar 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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