Overview

Phase Ib Study to Evaluate the Safety and Efficacy of TLL018 in Patients With Plaque Psoriasis

Status:
Not yet recruiting
Trial end date:
2022-12-30
Target enrollment:
0
Participant gender:
All
Summary
This study is a randomized, double-blind, placebo-controlled, multicenter clinical trial of about 70 subjects with moderate to severe plaque psoriasis.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hangzhou Highlightll Pharmaceutical Co., Ltd
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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.