Safety and Efficacy of TLL018 in Patients With Plaque Psoriasis

Moderate to Severe Plaque Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05342428
• Other study ID #: TLL018-203
• Status: Completed
• Phase: Phase 1
• Start date: June 10, 2022
• Est. completion date: August 30, 2023

Study information

• Verified date: July 2023
• Source: Hangzhou Highlightll Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: August 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Moderate to Severe Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• TLL018 tablets
Oral tablets administered at different doses BID daily for 12 weeks.

Locations

Country	Name	City	State
China	88 Jiefang Road, Shangcheng District, Hangzhou City, Zhejiang Province	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Hangzhou Highlightll Pharmaceutical Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	adverse events (AEs) according to severity	Number of adverse events (AEs) according to severity	From day 1 to Weeks 12
Primary	blood pressure from baseline	Change of blood pressure from baseline	From day 1 to Weeks 12
Primary	pulse rate from baseline	Change of pulse rate from baseline	From day 1 to Weeks 12
Primary	respiratory rate from baseline	Change of respiratory rate from baseline	From day 1 to Weeks 12
Primary	temperature from baseline	Change of oral temperature from baseline	From day 1 to Weeks 12
Primary	clinical laboratory abnormalities compared to baseline	Number of participants with clinical laboratory abnormalities compared to baseline	From day 1 to Weeks 12
Primary	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
Primary	physical examination findings from baseline	Number of participants with changes in physical examination findings from baseline	From day 1 to Weeks 12
Primary	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	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
Secondary	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
Secondary	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
Secondary	(sPGA) 0/1 response at week 4	static Physician Global Assessment (sPGA) 0/1 response	Baseline to Weeks 4
Secondary	(sPGA) 0/1 response at week 8	static Physician Global Assessment (sPGA) 0/1 response	Baseline to Weeks 8
Secondary	(sPGA) 0/1 response at week 12	static Physician Global Assessment (sPGA) 0/1 response	Baseline to Weeks 12