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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 belowSelect...
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:Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ from week 4 to weeks 12(except week 12)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from week 4 to weeks 12(except week 12)
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of alcohol or drug abuse in the last 6 months before screening.I do not have any severe or worsening health issues affecting my kidneys, liver, blood, stomach, hormones, lungs, heart, brain, or mental health.I have no cancer history, except possibly cured skin or early cervical cancer.I have an autoimmune disease, but not psoriatic arthritis.I have a specific type of psoriasis, not the common plaque type.Your BMI lies between 18.0 and 35.0 kg/m2, inclusive.I haven't had a serious infection in the last 45 days.I have had moderate-to-severe plaque psoriasis for at least 6 months.I have been exposed to or treated for TB recently.You are currently pregnant or breastfeeding.I am between 18 and 75 years old.I have tested positive for hepatitis B, hepatitis C, or HIV.My psoriasis covers more than 10% of my body and is moderately to severely severe.You are able to provide consent and comply with research requirements.You are ready and capable of following all study regulations.Your laboratory and medical history parameters are within the designated ranges.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 4
- Group 2: Cohort 2
- Group 3: Cohort 3
- Group 4: Cohort 1
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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