Safety and Efficacy of TLL018 in Patients With Plaque Psoriasis

Phase 1

Completed

• Conditions: Moderate to Severe Plaque Psoriasis
• Interventions: Drug: TLL018 tablets

• Registration Number: NCT05342428
• Lead Sponsor: Hangzhou Highlightll Pharmaceutical Co., Ltd

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.

Study Timeline

• Study First Submitted: 2022-04-07
• Study First Submitted QC: 2022-04-18
• Study First Posted: 2022-04-22
• Study Start: 2022-06-10
• Status Verified: 2023-07
• Primary Completion: 2023-08-30
• Study Completion: 2023-08-30
• Last Update Submitted: 2023-09-20
• Last Update Posted: 2023-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 2	TLL018 tablets	TLL018 tablets, 2pieces, BID
Cohort 1	TLL018 tablets	TLL018 tablets, 1piece,BID
Cohort 3	TLL018 tablets	TLL018 tablets, 3pieces, BID
Cohort 4	TLL018 tablets	TLL018 placeboes, 3pieces, BID

Primary Outcome Measures

Name	Time	Method
treatment-emergent adverse events (AEs), serious adverse events (SAEs) and discontinuation due to AEs/SAEs	From day 1 to Weeks 12	Number of participants with treatment-emergent adverse events (AEs), serious adverse events (SAEs) and discontinuation due to AEs/SAEs
blood pressure from baseline	From day 1 to Weeks 12	Change of blood pressure from baseline
adverse events (AEs) according to severity	From day 1 to Weeks 12	Number of adverse events (AEs) according to severity
pulse rate from baseline	From day 1 to Weeks 12	Change of pulse rate from baseline
respiratory rate from baseline	From day 1 to Weeks 12	Change of respiratory rate from baseline
temperature from baseline	From day 1 to Weeks 12	Change of oral temperature from baseline
clinical laboratory abnormalities compared to baseline	From day 1 to Weeks 12	Number of participants with clinical laboratory abnormalities compared to baseline
Cmax of TLL018	0 hour (pre-dose - within 30 minutes prior to dosing), and at 0.5, 1, 2, 4 and 12 hours post-dose	Maximum observed plasma concentration (Cmax) of TLL018
ECG parameters from baseline	From day 1 to Weeks 12	Change in 12-lead electrocardiogram (ECG) parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) from baseline
physical examination findings from baseline	From day 1 to Weeks 12	Number of participants with changes in physical examination findings from baseline

Secondary Outcome Measures

Name	Time	Method
PASI score decreased from baseline at week 4	Baseline to Week 4	The percentage of subjects whose PASI score decreased by at least 50%(PASI 50) 75%(PASI 75) 90%(PASI 90) and 100%(PASI 100) from baseline at week 4 when comparing TLL-018 with placebo
(sPGA) 0/1 response at week 8	Baseline to Weeks 8	static Physician Global Assessment (sPGA) 0/1 response
(sPGA) 0/1 response at week 12	Baseline to Weeks 12	static Physician Global Assessment (sPGA) 0/1 response
PASI score decreased from baseline at week 8	Baseline to Week 8	The percentage of subjects whose PASI score decreased by at least 50%(PASI 50) 75%(PASI 75) 90%(PASI 90) and 100%(PASI 100) from baseline at week 8 when comparing TLL-018 with placebo
PASI score decreased from baseline at week 12	Baseline to Week 12	The percentage of subjects whose PASI score decreased by at least 50%(PASI 50) 75%(PASI 75) 90%(PASI 90) and 100%(PASI 100) from baseline at week 12 when comparing TLL-018 with placebo
(sPGA) 0/1 response at week 4	Baseline to Weeks 4	static Physician Global Assessment (sPGA) 0/1 response

Trial Locations

Locations (1)

88 Jiefang Road, Shangcheng District, Hangzhou City, Zhejiang Province; 🇨🇳 Hangzhou, Zhejiang, China