Status:
COMPLETED
Safety and Efficacy of TLL018 in Patients With Plaque Psoriasis
Lead Sponsor:
Hangzhou Highlightll Pharmaceutical Co., Ltd
Conditions:
Moderate to Severe Plaque Psoriasis
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This study is a randomized, double-blind, placebo-controlled, multicenter clinical trial of about 70 subjects with moderate to severe plaque psoriasis.
Detailed Description
Successfully screened subjects will be randomized in a ratio of 2:2:2:1 and stratified to previous biologics use for psoriasis. After a 4-week screening period (day -28-0), subjects will be randomly ...
Eligibility Criteria
Inclusion
- Have had a diagnosis of moderate to severe plaque psoriasis for at least 6 months prior to Baseline;
- Subjects with moderate to severe plaque psoriasis covering ≥10% BSA, with a PASI ≥12 and sPGA score ≥3 at Baseline;
- Able and willing to give written informed consent.
Exclusion
- Other types of psoriasis (such as erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, etc.);
- Current drug-induced psoriasis, e.g., a new onset of psoriasis or an exacerbation of psoriasis induced by beta blockers, calcium channel blockers, antimalarial drugs or lithium;
- 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.
Key Trial Info
Start Date :
June 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2023
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT05342428
Start Date
June 10 2022
End Date
August 30 2023
Last Update
September 22 2023
Active Locations (1)
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1
88 Jiefang Road, Shangcheng District, Hangzhou City, Zhejiang Province
Hangzhou, Zhejiang, China, 310009