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Plaque PsoriasisPhase 2NCT05772520

The Efficacy and Safety of TLL018 in Moderate-to-severe Plaque Psoriasis

A Phase 2 study testing TLL018 tablets in people with Plaque Psoriasis, run by Hangzhou Highlightll Pharmaceutical Co., Ltd at 35 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Plaque Psoriasis
What is being tested?
TLL018 tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
35 sitesUnited States
Study dates
19 Jan 2023to 23 Dec 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • Participants with plaque psoriasis who are systemic treatment naïve or have received at least one of the conventional anti-psoriasis treatments such as acitretin, phototherapy, methotrexate, cyclosporine, apremilast, or biologic therapy (anti-TNF or anti-IL-12/17/23).
  • Participants who are candidates for systemic treatment for psoriasis at the discretion of the Investigator.
  • Must agree to avoid prolonged exposure (> 15 minutes) to the sun and avoid use of tanning booths or other ultraviolet light sources during the study.
  • Female participants of childbearing potential (See Section 10.4.1 definition of Woman of Childbearing Potential - WOCBP) must have a negative serum human chorionic gonadotropin (hCG) at Screening, and meet one of the following criteria:
  • Using a medically acceptable form of birth control (Appendix 4) for at least 1 month prior to Screening and 3 months after the last dose of study drug (e.g., hormonal contraceptives [oral, patch, injectable or vaginal ring], implantable device [implantable rod or intrauterine device], bilateral tubal occlusion/tubal ligation, azoospermic partner).
  • Abstinence as a form of birth control is generally not permitted during the study with the exception of participants who practice abstinence as a preferred and usual lifestyle style choice. The Investigator must confirm that abstinence is still in accordance with the participant's lifestyle at regular intervals throughout the study.
  • Male participants with female partners of childbearing potential must agree to use condoms for the duration of the study and until 13 weeks after administration of the study intervention and must refrain from donating sperm for this same period. In addition, his female partner should agree to use a highly effective method of birth control per Appendix 4 or an additional barrier form of birth control (e.g., diaphragm, cervical cap, spermicide, or sponge).)
  • Ability to swallow and retain oral study intervention.
  • Participants must have completed their coronavirus disease 2019 (COVID-19) vaccination in accordance with the latest CDC guidelines, which is based on previous vaccination history. Please reference COVID-19 vaccination guidance for individuals who are moderately or severely immunocompromised (Clinical Guidance for COVID-19 Vaccination | CDC).
  • Previous Pfizer-BioNTech, Moderna or Novavax: Must have previously received at least a 1st and 2nd dose, then must have received an updated formulation according to the CDCs dosing requirements; or
  • Novavax or Johnson and Johnson's Janssen: Must have previously received 1 or more doses in combination with any original monovalent or bivalent COVID-19 vaccine doses, then must receive an updated formulation according to the CDCs vaccination guidelines.
  • ...

Who cannot join

  • Pregnant or nursing women.
  • Past history of gastrointestinal perforation, history of peptic ulcers and/or regular use of NSAIDs.
  • 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).
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  • 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.
  • Recent exposure to active tuberculosis (TB). Current evidence of active TB or current evidence of latent TB. Participants with positive TB test (e.g., QuantiFERON) that have been treated for latent TB. A borderline QuantiFERON test should be repeated. If still indeterminant, then a chest x-ray may be performed (positive chest x-ray is exclusionary).
  • History of unexplained syncope, symptomatic hypotension, or hypoglycemia.
  • Abnormal D-dimer levels in conjunction with clinical or current and past thrombotic disease.
  • Participants with uncontrolled hypertension, uncontrolled diabetes, untreated or uncontrolled hyperlipidemia (fasting blood triglycerides >500 mg/dL and fasting cholesterol >250 mg/dL).
  • History of any significant cardiac event (e.g., myocardial infarction) within 6 months prior to Screening, including:
  • History of long QTc syndrome; history or presence of an abnormal ECG, which, in the Investigator's opinion, is clinically significant.
  • History of unstable ischemic heart disease or uncontrolled hypertension.
  • Current Class 3 or 4 heart failure per the New York Heart Association Functional Classification.
  • Screening and/or Baseline QTcF > 450 msec for males and > 470 msec for females, confirmed by triplicate ECG.
  • Participants with history of thrombosis and/ or thromboembolism, or associated risk factors (e.g., inherited thrombophilias, etc.).
  • Donated or lost >500 mL of blood in the previous 3 months.
  • Participants with chronic kidney disease with eGFR <60 mL/min/1.73 m2.
  • Participants with moderate-to-severe hepatic impairment (i.e., Child-Pugh Class B and C).
  • Major surgery within 3 months prior to Screening or participant has a planned major surgery during the course of the study.
  • Participants with any of the following abnormalities in clinical laboratory tests at Screening, as assessed by the study-specific laboratory and confirmed by a single repeat, if deemed necessary:
  • Hemoglobin <100 g/L
  • White blood cell (WBC) count of <3.0 × 109/L
  • Platelet count of <80 × 109/L
  • Absolute neutrophil count of <1.5 × 109/L
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) values greater than 3 times the ULN
  • Any uncontrolled clinically significant laboratory abnormality that would affect interpretation of study data or the participant's participation in the study.
  • Previous or current autoimmune diseases (e.g., RA, systemic lupus erythematosus, IBD, scleroderma, inflammatory myopathy, mixed connective tissue disease overlap syndrome, etc.). Note, psoriatic arthritis patients are allowed.
  • Other types of psoriasis (such as erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, drug-induced psoriasis).
  • Current enrollment in another study intervention protocol or experimental treatment within 30 days or five half-lives (whichever is longer).
  • Received any topical therapy that can affect psoriasis (including topical use of moderate-strong glucocorticoids, retinoids, vitamin D3 derivatives, salicylic acid, anthracene, etc.) within 2 weeks of first study intervention. Low potency topical steroids are permitted for sensitive areas only (e.g., face, axillae, genitalia). Bland emollients without urea or α or β-hydroxy acids are permitted.
  • Use of phototherapy (including photochemotherapy, ultraviolet therapy, tanning bed self-therapy, etc.) within 4 weeks of first study intervention.
  • Use of systemic oral therapy that can affect psoriasis (including but not limited to glucocorticoids, retinoids, cyclosporine, methotrexate and apremilast) within 4 weeks of first study intervention.
  • Received intravenous corticosteroids within 4 weeks of first study intervention.
  • Use of antimalarial drugs, interferon-α, lithium and beta-blockers within 4 weeks of first study intervention.
  • Use of Chinese or herbal medicine treatment of psoriasis within 2 weeks of first study intervention.
  • Prior to randomization, washout periods of the following biologics are required: etanercept ≥28 days; any s.c. mAb targeting TNF (eg., infliximab, adalimumab, certolizumab) >3 months; ustekinumab or drugs that specifically target IL-23>6 months; secukinumab, ixekizumab, bimekizumab, brodalumab or other IL-17 antagonists >6 months; any other anti-psoriasis treatments not listed within 5 half-lives. Topical JAK inhibitors should have a washout period > 2 weeks.
  • Prior use of three or more biologic therapies.
  • Use of natalizumab and other drugs that regulate B or T cells within 12 months of first study intervention, such as rituximab, alemtuzumab, and abatacept.
  • Participants who have received live vaccines within 2 months prior to first study intervention or plan to receive live vaccines during the study period. Non-live-attenuated vaccines (e.g., ribonucleic acid [RNA]-based vaccines, inactivated adenovirus-based vaccines, protein-based vaccines), including non-live-attenuated vaccines or boosters for coronavirus disease 2019 (COVID-19) during the study are allowed.
  • Participants who have received COVID-19 vaccines within 2 weeks of Baseline or participants who plan to receive COVID-19 vaccines during the study period (boosters are allowed).
  • Previously not completed COVID-19 vaccination in accordance with the CDC guidelines.
  • Participants who are allergic to any component of the study intervention or who are at risk for allergy as determined by the Investigator during the study.
  • Any condition for which the Investigator considers the participant inappropriate to participate in this study.
  • ....

Trial locations and contacts

35 sites in 1 country.

35 sites in 1 country

United States35 sites

  • Oakland Hills Dermatology

    Auburn Hills, Michigan, 48326

  • Derm Research

    Austin, Texas, 78759

  • Moy, Fincher, Chipps

    Beverly Hills, California, 90210

  • Cahaba

    Birmingham, Alabama, 35244

  • Metro Boston

    Brighton, Massachusetts, 02135

  • CRCC

    Charleston, South Carolina, 29407

  • Remington-Davis, Inc.

    Columbus, Ohio, 43215

  • Life Clinical Trials

    Coral Springs, Florida, 33071

  • Studies in Dermatology, LLC

    Cypress, Texas, 77433

  • Palm Beach

    DeLand, Florida, 33484

  • Integrated Clinical Trial Services, Inc

    Des Moines, Iowa, 50265

  • D&H Doral Research Center LLC

    Doral, Florida, 33122

  • Sweet Hope Research Specialty, Inc

    Hialeah, Florida, 33016

  • CNS - Jacksonville

    Jacksonville, Florida, 32256

  • CNS - Orlando SODO

    Jacksonville, Florida, 32256

  • Dermatology Associates of Knoxville

    Knoxville, Tennessee, 37909

  • Altus Research

    Lake Worth, Florida, 33461

  • Metropolis Derm

    Los Angeles, California, 90017

  • Anchor Medical Research, LLC (Core Clinical Trials)

    Miami, Florida, 33176

  • Reserka Research

    Miami, Florida, 33176

  • IMA Clinical Research

    Monroe, Louisiana, 71201

  • Minnesota Clinical Study Center

    New Ulm, Minnesota, 55112

  • Mount Sinai

    New York, New York, 10003

  • Sadick Research Group

    New York, New York, 10075

  • Amicis Research Center

    Northridge, California, 91324

  • Austin Institute for Clinical Research

    Pflugerville, Texas, 78660

  • Lawrence Green

    Rockville, Maryland, 20850

  • Integrative Skin

    Sacramento, California, 95815

  • Progressive Clinical Research Group, Inc.

    San Antonio, Texas, 78213

  • Skin Surgical

    San Diego, California, 92117

  • Acclaim

    Sugar Land, Texas, 77479

  • DermDox

    Sugarloaf, Pennsylvania, 18249

  • ForCare Medical (CenExcel)

    Tampa, Florida, 33613

  • Revival Research Institute

    Troy, Michigan, 48084

  • Grekin Skin

    Warren, Michigan, 48088

Other trials in United States

About this study

Official title: A Randomized, Double-blinded, Placebo-controlled, Multicenter Phase 2 Study Evaluating the Efficacy and Safety of TLL018 in Participants With Moderate-to-severe Plaque Psoriasis

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.

Being tested
TLL018 tablets

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TLL018 tabletsDrug

    Also called TLL018 Placeboes

    oral tablets administered 20 mg BID and 40 mg BID for 12 weeks

Study groups in NCT05772520
Study groupRoleWhat they receive
Cohort 2ExperimentalTLL018 tables, 20 mg 1piece,BID
Receives: Drug: TLL018 tablets
Cohort 3ExperimentalTLL018 tables, 40 mg 1piece,BID
Receives: Drug: TLL018 tablets
Cohort 4Experimentalplacebo, 1piece,BID
Receives: Drug: TLL018 tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Participants Achieving PASI-75 (FAS)

    A PASI 75 response is defined as achieving at least a 75% improvement (reduction) in the Psoriasis Area and Severity Index (PASI) score from baseline. The PASI is a composite tool that assesses the overall severity of erythema, induration, and scaling, as well as the extent of body surface area involvement. The total PASI score ranges from 0 to 72, with higher scores indicating more severe disease. The results are in Full Analysis Set (FAS).

    Measured: Week12

  2. Proportion of Participants Achieving PASI 75 (PPS)

    A PASI 75 response is defined as achieving at least a 75% improvement (reduction) in the Psoriasis Area and Severity Index (PASI) score from baseline. The PASI is a composite tool that assesses the overall severity of erythema, induration, and scaling, as well as the extent of body surface area involvement. The total PASI score ranges from 0 to 72, with higher scores indicating more severe disease. The results are in Per-Protocol Set. Excludes participants with major protocol violations.

    Measured: Week12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2023
  2. Study start19 Jan 2023
  3. Primary completion1 Dec 2024
  4. Study completion23 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05772520
Sponsor's protocol ID
TLL018-205
Status last verified
Jun 2026
First submitted
6 Mar 2023
Last updated
21 Jul 2026
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TLL018 tablets in people with Plaque Psoriasis, run by Hangzhou Highlightll Pharmaceutical Co., Ltd at 35 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 47 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Participants Achieving PASI-75 (FAS) (time frame: Week12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05772520.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.

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