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Unknown

TLL018 Tablets for Plaque Psoriasis

Phase 2
Recruiting
Research Sponsored by Hangzhou Highlightll Pharmaceutical Co., Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age between 18 and 75 years at time of informed consent
Moderate-to-severe PP covering ≥10% body surface area (BSA), with a Psoriasis Area and Severity Index (PASI) ≥12 and a static Physician's Global Assessment (PGA) score ≥3 at Baseline
Must not have
Current and/or recent history of severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular, neurologic, or psychiatric disease
Tests positive for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV). Hepatitis B test result positive definition: 1) hepatitis B surface antigen (HBsAg) positive, or 2) Hepatitis B core antibody positive and hepatitis B virus deoxyribonucleic acid positive or beyond the upper limit of normal (ULN) value; positive hepatitis C virus result is defined as having a positive hepatitis C antibody test with a positive confirmatory hepatitis C polymerase chain reaction test
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from week 4 to weeks 12(except week 12)

Summary

This trial tests if a drug is safe and effective for people with severe skin conditions.

Who is the study for?
Adults aged 18-75 with a BMI of 18.0 to 35.0, diagnosed with moderate-to-severe plaque psoriasis covering at least 10% body surface for over six months can join this trial. They must have certain severity scores and be able to follow the study rules but cannot participate if pregnant, nursing, or have recent substance abuse history, significant infections, hepatitis B/C, HIV, TB exposure or other autoimmune diseases (except psoriatic arthritis).
What is being tested?
The trial is testing TLL018 tablets' effectiveness and safety in treating moderate-to-severe plaque psoriasis compared to a placebo. It's a Phase 2 study where participants are randomly assigned into groups receiving different doses of TLL018 or placebo without knowing which one they're getting.
What are the potential side effects?
While specific side effects for TLL018 aren't listed here, common side effects for treatments like these may include skin reactions at the site of treatment, gastrointestinal issues such as nausea or diarrhea, potential liver function changes and an increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 75 years old.
Select...
My psoriasis covers more than 10% of my body and is moderately to severely severe.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any severe or worsening health issues affecting my kidneys, liver, blood, stomach, hormones, lungs, heart, brain, or mental health.
Select...
I have tested positive for hepatitis B, hepatitis C, or HIV.
Select...
I have a specific type of psoriasis, not the common plaque type.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from week 4 to weeks 12(except week 12)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from week 4 to weeks 12(except week 12) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
proportion of participants achieving PASI-75
Secondary study objectives
Proportion of participants achieving PASI-75 (except Week 12)
Proportion of participants achieving PASI-90
Proportion of participants achieving PGA score of 0 or 1

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Cohort 3Experimental Treatment1 Intervention
TLL018 tables, 40 mg 1piece,BID
Group II: Cohort 2Experimental Treatment1 Intervention
TLL018 tables, 20 mg 1piece,BID
Group III: Cohort 1Experimental Treatment1 Intervention
TLL018 tables, 10 mg 1piece,BID
Group IV: Cohort 4Placebo Group1 Intervention
placebo, 1piece,BID
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TLL018 tablets
2022
Completed Phase 1
~120

Find a Location

Who is running the clinical trial?

Hangzhou Highlightll Pharmaceutical Co., LtdLead Sponsor
7 Previous Clinical Trials
1,129 Total Patients Enrolled

Media Library

TLL018 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05772520 — Phase 2
Plaque Psoriasis Research Study Groups: Cohort 4, Cohort 2, Cohort 3, Cohort 1
Plaque Psoriasis Clinical Trial 2023: TLL018 Highlights & Side Effects. Trial Name: NCT05772520 — Phase 2
TLL018 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05772520 — Phase 2
~41 spots leftby Dec 2025
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