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

NCT05373355 | Completed Phase 1

• 1 other identifier: TLL018-204
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Spontaneous Urticaria

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (15)

• 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

  From week 4 to Weeks 12

• blood pressure from baseline

  From week 4 to Weeks 12

• pulse rate from baseline

  From week 4 to Weeks 12

• respiratory rate from baseline

  From week 4 to Weeks 12

Study Arms (3)

Cohort 1

EXPERIMENTAL

TLL018 tablets 1piece,BID

Drug: TLL018 tablets

Cohort 2

EXPERIMENTAL

TLL018 tablets 3pieces, BID

Drug: TLL018 tablets

Cohort 3

PLACEBO COMPARATOR

TLL018 placeboes 3pieces, BID

Drug: TLL018 tablets

Interventions

TLL018 tablets DRUG

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

Also known as: TLL018 Placeboes

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hangzhou Highlightll Pharmaceutical Co., Ltd: lead

Study Sites (1)

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

Nanjing, Jiangsu, 210042, China

Location

MeSH Terms

Conditions

Chronic Urticaria

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 13, 2022
• Study Start: May 10, 2022
• Primary Completion: September 7, 2023
• Study Completion: September 7, 2023
• Last Updated: March 1, 2024

Record last verified: 2023-10

Locations

CN (1)