Skip to main content
OpenTrials
Completed

NCT Number: NCT05342428

Safety and Efficacy of TLL018 in Patients With Plaque Psoriasis

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Hangzhou, Zhejiang, 310009, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TLL018 tablets

Drug

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

Other names: TLL018 Placeboes

Primary outcomes

  1. treatment-emergent adverse events (AEs), serious adverse events (SAEs) and discontinuation due to AEs/SAEs

    Time frame: 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

  2. adverse events (AEs) according to severity

    Time frame: From day 1 to Weeks 12

    Number of adverse events (AEs) according to severity

  3. blood pressure from baseline

    Time frame: From day 1 to Weeks 12

    Change of blood pressure from baseline

  4. pulse rate from baseline

    Time frame: From day 1 to Weeks 12

    Change of pulse rate from baseline

  5. respiratory rate from baseline

    Time frame: From day 1 to Weeks 12

    Change of respiratory rate from baseline

  6. temperature from baseline

    Time frame: From day 1 to Weeks 12

    Change of oral temperature from baseline

  7. clinical laboratory abnormalities compared to baseline

    Time frame: From day 1 to Weeks 12

    Number of participants with clinical laboratory abnormalities compared to baseline

  8. ECG parameters from baseline

    Time frame: From day 1 to Weeks 12

    Change in 12-lead electrocardiogram (ECG) parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) from baseline

  9. physical examination findings from baseline

    Time frame: From day 1 to Weeks 12

    Number of participants with changes in physical examination findings from baseline

  10. Cmax of TLL018

    Time frame: 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

Secondary outcomes

  1. PASI score decreased from baseline at week 4

    Time frame: 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

  2. PASI score decreased from baseline at week 8

    Time frame: 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

  3. PASI score decreased from baseline at week 12

    Time frame: 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

  4. (sPGA) 0/1 response at week 4

    Time frame: Baseline to Weeks 4

    static Physician Global Assessment (sPGA) 0/1 response

  5. (sPGA) 0/1 response at week 8

    Time frame: Baseline to Weeks 8

    static Physician Global Assessment (sPGA) 0/1 response

  6. (sPGA) 0/1 response at week 12

    Time frame: Baseline to Weeks 12

    static Physician Global Assessment (sPGA) 0/1 response

Sponsors and collaborators

Lead sponsor

Hangzhou Highlightll Pharmaceutical Co., Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 22, 2022
Registry last updated
Sep 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.