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

NCT05772520 | Completed Phase 2 FDA Drug

• 1 other identifier: TLL018-205
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 35

Brief 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.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• proportion of participants achieving PASI-75

  A patient was a responser if a minimum 75% PASI improvement from Baseline was achieved including measure of the average redness (erythema), thickness (induration), and scaliness (scaling) In calculating the PASI, severity is determined by dividing the body into four regions: head (h), upper extremities (u), trunk (t), and lower extremities (l).Each of these areas is assessed separately for erythema, induration, and scaling, which are rated on a scale of 0 (none) to 4 (very severe). Extent of psoriatic involvement is graded as follows: 0 = no involvement 1. = 1% to 9% 2. = 10% to 29% 3. = 30% to 49% 4. = 50% to 69% 5. = 70% to 89% 6. = 90% to 100%. PASI = 0.1 (Eh + lh + Sh) Ah + 0.2 (Eu + lu + Su) Au + 0.3 (Et +lt + St) At + 0.4 (El +ll +Sl) Al

  Week12

Secondary Outcomes (3)

• Proportion of participants achieving PGA score of 0 or 1

  From week 4 to Weeks 12

• Proportion of participants achieving PASI-75 (except Week 12)

  From week 4 to Weeks 12(except Week 12)

• Proportion of participants achieving PASI-90

  From week 4 to Weeks 12

Study Arms (3)

Cohort 2

EXPERIMENTAL

TLL018 tables, 20 mg 1piece,BID

Drug: TLL018 tablets

Cohort 3

EXPERIMENTAL

TLL018 tables, 40 mg 1piece,BID

Drug: TLL018 tablets

Cohort 4

EXPERIMENTAL

placebo, 1piece,BID

Drug: TLL018 tablets

Interventions

TLL018 tablets DRUG

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

Also known as: TLL018 Placeboes

Cohort 2; Cohort 3; Cohort 4

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).)

You may not qualify if:

• 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).
• 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.
• 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.

Sponsors & Collaborators

• Hangzhou Highlightll Pharmaceutical Co., Ltd: lead

Study Sites (35)

Cahaba

Birmingham, Alabama, 35244, United States

Location

Moy, Fincher, Chipps

Beverly Hills, California, 90210, United States

Location

Metropolis Derm

Los Angeles, California, 90017, United States

Location

Amicis Research Center

Northridge, California, 91324, United States

Location

Integrative Skin

Sacramento, California, 95815, United States

Location

Skin Surgical

San Diego, California, 92117, United States

Location

Life Clinical Trials

Coral Springs, Florida, 33071, United States

Location

Palm Beach

DeLand, Florida, 33484, United States

Location

D&H Doral Research Center LLC

Doral, Florida, 33122, United States

Location

Sweet Hope Research Specialty, Inc

Hialeah, Florida, 33016, United States

Location

CNS - Jacksonville

Jacksonville, Florida, 32256, United States

Location

CNS - Orlando SODO

Jacksonville, Florida, 32256, United States

Location

Altus Research

Lake Worth, Florida, 33461, United States

Location

Anchor Medical Research, LLC (Core Clinical Trials)

Miami, Florida, 33176, United States

Location

Reserka Research

Miami, Florida, 33176, United States

Location

ForCare Medical (CenExcel)

Tampa, Florida, 33613, United States

Location

Integrated Clinical Trial Services, Inc

Des Moines, Iowa, 50265, United States

Location

IMA Clinical Research

Monroe, Louisiana, 71201, United States

Location

Lawrence Green

Rockville, Maryland, 20850, United States

Location

Metro Boston

Brighton, Massachusetts, 02135, United States

Location

Oakland Hills Dermatology

Auburn Hills, Michigan, 48326, United States

Location

Revival Research Institute

Troy, Michigan, 48084, United States

Location

Grekin Skin

Warren, Michigan, 48088, United States

Location

Minnesota Clinical Study Center

New Ulm, Minnesota, 55112, United States

Location

Mount Sinai

New York, New York, 10003, United States

Location

Sadick Research Group

New York, New York, 10075, United States

Location

Remington-Davis, Inc.

Columbus, Ohio, 43215, United States

Location

DermDox

Sugarloaf, Pennsylvania, 18249, United States

Location

CRCC

Charleston, South Carolina, 29407, United States

Location

Dermatology Associates of Knoxville

Knoxville, Tennessee, 37909, United States

Location

Derm Research

Austin, Texas, 78759, United States

Location

Studies in Dermatology, LLC

Cypress, Texas, 77433, United States

Location

Austin Institute for Clinical Research

Pflugerville, Texas, 78660, United States

Location

Progressive Clinical Research Group, Inc.

San Antonio, Texas, 78213, United States

Location

Acclaim

Sugar Land, Texas, 77479, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 16, 2023
• Study Start: January 19, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 23, 2024
• Last Updated: December 27, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (35)