Clinical trial NCT05373355: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Spontaneous Urticaria
Lead sponsor: Hangzhou Highlightll Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2022-05-13
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: treatment-emergent adverse events (AEs), serious adverse events (SAEs) and discontinuation due to AEs/SAEs
timeFrame: From day 1 to Weeks 4
measure: adverse events (AEs) according to severity
timeFrame: From day 1 to Weeks 4
measure: blood pressure from baseline
timeFrame: From day 1 to Weeks 4
measure: pulse rate from baseline
timeFrame: From day 1 to Weeks 4
measure: respiratory rate from baseline
timeFrame: From day 1 to Weeks 4
measure: temperature from baseline
timeFrame: From day 1 to Weeks 4
measure: clinical laboratory abnormalities compared to baseline
timeFrame: From day 1 to Weeks 4
measure: ECG parameters from baseline
timeFrame: From day 1 to Weeks 4
measure: physical examination findings from baseline
timeFrame: From day 1 to Weeks 4
measure: Cmax of TLL018
timeFrame: 0 hour (pre-dose - within 30 minutes prior to dosing), and at 0.5, 1, 2, 4 and 8 hours post-dose
Secondary outcomes:
measure: treatment-emergent adverse events (AEs), serious adverse events (SAEs) and discontinuation due to AEs/SAEs
timeFrame: From week 4 to Weeks 12
measure: adverse events (AEs) according to severity
timeFrame: From week 4 to Weeks 12
measure: blood pressure from baseline
timeFrame: From week 4 to Weeks 12
measure: pulse rate from baseline
timeFrame: From week 4 to Weeks 12
measure: respiratory rate from baseline
timeFrame: From week 4 to Weeks 12
measure: temperature from baseline
timeFrame: From week 4 to Weeks 12
measure: clinical laboratory abnormalities compared to baseline
timeFrame: From week 4 to Weeks 12
measure: ECG parameters from baseline
timeFrame: From week 4 to Weeks 12
measure: physical examination findings from baseline
timeFrame: From week 4 to Weeks 12
measure: UAS7 score decreased from baseline at week 4
timeFrame: Baseline to Week 4
measure: UAS7 score decreased from baseline at week 8
timeFrame: Time Frame: Baseline to Week 8
measure: UAS7 score decreased from baseline at week 12
timeFrame: Baseline to Week 12
measure: DLQI score decreased from baseline at week 4
timeFrame: Baseline to Weeks 4
measure: DLQI score decreased from baseline at week 8
timeFrame: Baseline to Weeks 8
measure: DLQI score decreased from baseline at week 12
timeFrame: Baseline to Weeks 12
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Hospital For Skin Diseases,Institute of Dermatology Chinese Academy of Medical Sciences, Peking Union Medical College
state: Jiangsu
Study officials:
References: