Safety and Efficacy of TLL018 in Patients With Plaque Psoriasis

NCT ID: NCT05342428

Last Updated: 2023-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-10
• Study Completion Date: 2023-08-30

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 assigned to treatment for 12 weeks.

Clinical psoriasis area and severity index (PASI), Physician's Global Assessment (PGA), 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

Moderate to Severe Plaque Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Cohort 1

TLL018 tablets, 1piece,BID

Group Type: EXPERIMENTAL

TLL018 tablets

Intervention Type: DRUG

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

Cohort 2

TLL018 tablets, 2pieces, BID

Group Type: EXPERIMENTAL

TLL018 tablets

Intervention Type: DRUG

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

Cohort 3

TLL018 tablets, 3pieces, BID

Group Type: EXPERIMENTAL

TLL018 tablets

Intervention Type: DRUG

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

Cohort 4

TLL018 placeboes, 3pieces, BID

Group Type: PLACEBO_COMPARATOR

TLL018 tablets

Intervention Type: DRUG

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

Interventions

TLL018 tablets

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

Intervention Type: DRUG

Other Intervention Names

TLL018 Placeboes

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hangzhou Highlightll Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

88 Jiefang Road, Shangcheng District, Hangzhou City, Zhejiang Province

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

TLL018-203

Identifier Type: -

Identifier Source: org_study_id