Trials / Completed
CompletedNCT05373355
Safety and Efficacy of TLL018 in Patients With Chronic Spontaneous Urticaria.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 41 (actual)
- Sponsor
- Hangzhou Highlightll Pharmaceutical Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TLL018 tablets | Oral tablets administered at different doses BID daily for 12 weeks. |
Timeline
- Start date
- 2022-05-10
- Primary completion
- 2023-09-07
- Completion
- 2023-09-07
- First posted
- 2022-05-13
- Last updated
- 2024-03-01
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05373355. Inclusion in this directory is not an endorsement.