Safety and Efficacy of TLL018 in Patients With Plaque Psoriasis

A Phase Ⅰb, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Pharmacokinetics of TLL-018 in Subjects With Moderate to Severe Plaque Psoriasis

This study is a randomized, double-blind, placebo-controlled, multicenter clinical trial of about 70 subjects with moderate to severe plaque psoriasis.

Study Overview

• Status: Completed
• Conditions: Moderate to Severe Plaque Psoriasis
• Intervention / Treatment: Drug: TLL018 tablets

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 Type: Interventional
• Enrollment (Actual): 73
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • 88 Jiefang Road, Shangcheng District, Hangzhou City, Zhejiang Province

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; TLL018 tablets, 1piece,BID	Drug: TLL018 tablets; Oral tablets administered at different doses BID daily for 12 weeks.; Other Names: TLL018 Placeboes
Experimental: Cohort 2; TLL018 tablets, 2pieces, BID	Drug: TLL018 tablets; Oral tablets administered at different doses BID daily for 12 weeks.; Other Names: TLL018 Placeboes
Experimental: Cohort 3; TLL018 tablets, 3pieces, BID	Drug: TLL018 tablets; Oral tablets administered at different doses BID daily for 12 weeks.; Other Names: TLL018 Placeboes
Placebo Comparator: Cohort 4; TLL018 placeboes, 3pieces, BID	Drug: TLL018 tablets; Oral tablets administered at different doses BID daily for 12 weeks.; Other Names: TLL018 Placeboes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
treatment-emergent adverse events (AEs), serious adverse events (SAEs) and discontinuation due to AEs/SAEs	Number of participants with treatment-emergent adverse events (AEs), serious adverse events (SAEs) and discontinuation due to AEs/SAEs	From day 1 to Weeks 12
adverse events (AEs) according to severity	Number of adverse events (AEs) according to severity	From day 1 to Weeks 12
blood pressure from baseline	Change of blood pressure from baseline	From day 1 to Weeks 12
pulse rate from baseline	Change of pulse rate from baseline	From day 1 to Weeks 12
respiratory rate from baseline	Change of respiratory rate from baseline	From day 1 to Weeks 12
temperature from baseline	Change of oral temperature from baseline	From day 1 to Weeks 12
clinical laboratory abnormalities compared to baseline	Number of participants with clinical laboratory abnormalities compared to baseline	From day 1 to Weeks 12
ECG parameters from baseline	Change in 12-lead electrocardiogram (ECG) parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) from baseline	From day 1 to Weeks 12
physical examination findings from baseline	Number of participants with changes in physical examination findings from baseline	From day 1 to Weeks 12
Cmax of TLL018	Maximum observed plasma concentration (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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PASI score decreased from baseline at 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	Baseline to Week 4
PASI score decreased from baseline at 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	Baseline to Week 8
PASI score decreased from baseline at 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	Baseline to Week 12
(sPGA) 0/1 response at week 4	static Physician Global Assessment (sPGA) 0/1 response	Baseline to Weeks 4
(sPGA) 0/1 response at week 8	static Physician Global Assessment (sPGA) 0/1 response	Baseline to Weeks 8
(sPGA) 0/1 response at week 12	static Physician Global Assessment (sPGA) 0/1 response	Baseline to Weeks 12

Collaborators and Investigators

• Sponsor: Hangzhou Highlightll Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2022
• Primary Completion (Actual): August 30, 2023
• Study Completion (Actual): August 30, 2023

Study Registration Dates

• First Submitted: April 7, 2022
• First Submitted That Met QC Criteria: April 18, 2022
• First Posted (Actual): April 22, 2022

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: TLL018-203

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No