Safety and Efficacy of TLL018 in Patients With Plaque Psoriasis

NCT05342428 | Completed Phase 1

• 1 other identifier: TLL018-203
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Moderate to Severe Plaque Psoriasis

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (6)

• PASI score decreased from baseline at week 4

  Baseline to Week 4

• PASI score decreased from baseline at week 8

  Baseline to Week 8

• PASI score decreased from baseline at week 12

  Baseline to Week 12

• (sPGA) 0/1 response at week 4

  Baseline to Weeks 4

• (sPGA) 0/1 response at week 8

  Baseline to Weeks 8

Study Arms (4)

Cohort 1

EXPERIMENTAL

TLL018 tablets, 1piece,BID

Drug: TLL018 tablets

Cohort 2

EXPERIMENTAL

TLL018 tablets, 2pieces, BID

Drug: TLL018 tablets

Cohort 3

EXPERIMENTAL

TLL018 tablets, 3pieces, BID

Drug: TLL018 tablets

Cohort 4

PLACEBO COMPARATOR

TLL018 placeboes, 3pieces, BID

Drug: TLL018 tablets

Interventions

TLL018 tablets DRUG

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

Also known as: TLL018 Placeboes

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hangzhou Highlightll Pharmaceutical Co., Ltd: lead

Study Sites (1)

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

Hangzhou, Zhejiang, 310009, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 22, 2022
• Study Start: June 10, 2022
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2023
• Last Updated: September 22, 2023

Record last verified: 2023-07

Locations

CN (1)