Clinical trial NCT05342428: Safety and Efficacy of TLL018 in Patients With Plaque Psoriasis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Moderate to Severe Plaque Psoriasis
Lead sponsor: Hangzhou Highlightll Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2022-04-22
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: treatment-emergent adverse events (AEs), serious adverse events (SAEs) and discontinuation due to AEs/SAEs
timeFrame: From day 1 to Weeks 12
measure: adverse events (AEs) according to severity
timeFrame: From day 1 to Weeks 12
measure: blood pressure from baseline
timeFrame: From day 1 to Weeks 12
measure: pulse rate from baseline
timeFrame: From day 1 to Weeks 12
measure: respiratory rate from baseline
timeFrame: From day 1 to Weeks 12
measure: temperature from baseline
timeFrame: From day 1 to Weeks 12
measure: clinical laboratory abnormalities compared to baseline
timeFrame: From day 1 to Weeks 12
measure: ECG parameters from baseline
timeFrame: From day 1 to Weeks 12
measure: physical examination findings from baseline
timeFrame: From day 1 to Weeks 12
measure: Cmax of TLL018
timeFrame: 0 hour (pre-dose - within 30 minutes prior to dosing), and at 0.5, 1, 2, 4 and 12 hours post-dose
Secondary outcomes:
measure: PASI score decreased from baseline at week 4
timeFrame: Baseline to Week 4
measure: PASI score decreased from baseline at week 8
timeFrame: Baseline to Week 8
measure: PASI score decreased from baseline at week 12
timeFrame: Baseline to Week 12
measure: (sPGA) 0/1 response at week 4
timeFrame: Baseline to Weeks 4
measure: (sPGA) 0/1 response at week 8
timeFrame: Baseline to Weeks 8
measure: (sPGA) 0/1 response at week 12
timeFrame: Baseline to Weeks 12
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 88 Jiefang Road, Shangcheng District, Hangzhou City, Zhejiang Province
state: Zhejiang
Study officials:
References: