The Efficacy and Safety of TLL018 in Moderate-to-severe Plaque Psoriasis (NCT05772520) | Clinical Trial Compass
CompletedPhase 2
The Efficacy and Safety of TLL018 in Moderate-to-severe Plaque Psoriasis
United States82 participantsStarted 2023-01-19
Plain-language summary
This is a Phase 2, multicenter, randomized, double-blinded, parallel dose group, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of 2 doses of TLL018 as therapy in approximately 90 participants with moderate-to-severe PP.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Are between the ages of 18 and 75 years, inclusive, at time of informed consent.
. Capable of giving informed consent and complying with study procedures.
. Willing and able to adhere to study restrictions.
. Laboratory and medical history parameters within the protocol defined ranges.
. Normal renal function (\>90 mL/min/1.72 m2) or mild renal impairment (Stage 2 mild chronic kidney disease glomerular filtration rate \[GFR\] = 60 to 89 mL/min/1.73 m2) as determined by central laboratory.
. Body mass index (BMI) of 18.0 to 35.0 kg/m2 inclusive.
. Have had a diagnosis of moderate-to-severe PP for at least 6 months prior to Baseline.
. Participants with 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.
Exclusion criteria
. Pregnant or nursing women.
. Past history of gastrointestinal perforation, history of peptic ulcers and/or regular use of NSAIDs.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of Participants Achieving PASI-75 (FAS)
Timeframe: Week12
2
Proportion of Participants Achieving PASI 75 (PPS)
. History of chronic alcohol or drug abuse within 6 months prior to Screening as determined by the Investigator based on medical history and patient interview.
. Current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular, neurologic, or psychiatric disease.
. Current and/or recent history (\<30 days prior to Screening and/or \<45 days prior to randomization) of a clinically significant viral, bacterial, fungal, parasitic, or mycobacterial infection.
. Subject is currently being treated with or has received strong cytochrome P450 3A (CYP3A4) inhibitors, such as itraconazole, within 4 weeks prior to Baseline (Day 0).
. Any history of malignancies, except for non-recurrent basal cell skin cancer, squamous cell skin cancer, and cervical cancer in situ that are considered to be cured.
. Tests positive for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV). For Hepatitis B all subjects will undergo testing for Hepatitis B Surface Antigen (HBsAg) and Hepatitis B Core Antibody (HBcAb). Subjects who are HBsAg positive are not eligible for the study. Subjects who are HBsAg negative and HBcAb positive will subsequently need testing for Hepatitis B virus deoxyribonucleic acid (HBV DNA) and if HBV DNA negative may be enrolled in the study; if HBV DNA is positive, the subject is not eligible for the study. 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.