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

Study Purpose

This is a Phase 2, multicenter, randomized, double-blinded, parallel dose group, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of 3 doses of TLL018 as therapy in 120 participants with moderate-to-severe PP.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Are between the ages of 18 and 75 years, inclusive, at time of informed consent. 2. Capable of giving informed consent and complying with study procedures. 3. Willing and able to adhere to study restrictions. 4. Laboratory and medical history parameters within the protocol defined ranges. 5. Body mass index (BMI) of 18.0 to 35.0 kg/m2inclusive. 6. Have had a diagnosis of moderate-to-severe PP for at least 6 months prior to Baseline. 7. 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:

1. Pregnant or nursing women. 2. 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. 3. Current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular, neurologic, or psychiatric disease. 4. 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. 5. 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. 6. 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. 7. 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. 8. 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. 9. Other types of psoriasis (such as erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, drug-induced psoriasis) ....

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05772520
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Hangzhou Highlightll Pharmaceutical Co., Ltd
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Plaque Psoriasis
Arms & Interventions

Arms

Experimental: Cohort 1

TLL018 tables, 10 mg 1piece,BID

Experimental: Cohort 2

TLL018 tables, 20 mg 1piece,BID

Experimental: Cohort 3

TLL018 tables, 40 mg 1piece,BID

Placebo Comparator: Cohort 4

placebo, 1piece,BID

Interventions

Drug: - TLL018 tablets

oral tablets administered BID for 12weeks

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Cahaba, Birmingham, Alabama

Status

Recruiting

Address

Cahaba

Birmingham, Alabama, 35244

Site Contact

Jennifer Perry

jennifer@vialtrials.com

205-778-1564

Moy, Fincher, Chipps, Beverly Hills, California

Status

Recruiting

Address

Moy, Fincher, Chipps

Beverly Hills, California, 90210

Site Contact

Ron Moy

Ronmoymd@gmail.com

310-274-5372

Metropolis Derm, Los Angeles, California

Status

Recruiting

Address

Metropolis Derm

Los Angeles, California, 90017

Site Contact

Felicia Moten

trials@metropolisderm.com

213-319-3339

Integrative Skin, Sacramento, California

Status

Recruiting

Address

Integrative Skin

Sacramento, California, 95815

Site Contact

Elaine Ladmirault

elaine@integrativeskinresearch.com

916-524-1216

Skin Surgical, San Diego, California

Status

Recruiting

Address

Skin Surgical

San Diego, California, 92117

Site Contact

Sarah Mohsen

smohsen@skinsurgerymed.com

858-292-5101 #110

Life Clinical Trials, Coral Springs, Florida

Status

Recruiting

Address

Life Clinical Trials

Coral Springs, Florida, 33071

Site Contact

Alondra Escoto

aescoto@lctresearch.com

754-777-2714

Palm Beach, DeLand, Florida

Status

Recruiting

Address

Palm Beach

DeLand, Florida, 33484

Site Contact

Sammy Ayoub

sammy@adamplotkin.com

561-559-1516

D&H Doral Research Center LLC, Doral, Florida

Status

Recruiting

Address

D&H Doral Research Center LLC

Doral, Florida, 33122

Site Contact

Marlon Hernandez

marlonher@dhtrc.com

786-698-8508

CNS - Jacksonville, Jacksonville, Florida

Status

Recruiting

Address

CNS - Jacksonville

Jacksonville, Florida, 32256

Site Contact

Ivy Gabon

igabon@cnshealthcare.com

904-281-5757

Altus Research, Lake Worth, Florida

Status

Recruiting

Address

Altus Research

Lake Worth, Florida, 33461

Site Contact

Florinda Francisco

ffrancisco@altusresearch.com

561-641-0404 #111

AQUA - Riverchase, Pembroke Pines, Florida

Status

Withdrawn

Address

AQUA - Riverchase

Pembroke Pines, Florida, 33028

Integrated Clinical Trial Services, Inc, Des Moines, Iowa

Status

Recruiting

Address

Integrated Clinical Trial Services, Inc

Des Moines, Iowa, 50265

Site Contact

Shelby Simpson

ssimpson@ictsiowa.com

515-229-1413

Lawrence Green, Rockville, Maryland

Status

Recruiting

Address

Lawrence Green

Rockville, Maryland, 20850

Site Contact

Jessica Baccouche

jessica@aederm.com

301-610-0663 #110

Metro Boston, Brighton, Massachusetts

Status

Recruiting

Address

Metro Boston

Brighton, Massachusetts, 02135

Site Contact

Stella Schandorf

sschandorf@metrobostoncp.com

781-444-0900

Grekin Skin, Warren, Michigan

Status

Recruiting

Address

Grekin Skin

Warren, Michigan, 48088

Site Contact

Claudia Attala

claudia.attala@adcsclinics.com

586-759-5525 #3

Revival Research Institute, Troy, Missouri

Status

Recruiting

Address

Revival Research Institute

Troy, Missouri, 48084

Site Contact

Yamini Donekal

ydonekal@rev-research.com

248-590-0298

Mount Sinai, New York, New York

Status

Recruiting

Address

Mount Sinai

New York, New York, 10003

Site Contact

Grace Ulerio

grace.ulerio@mssm.edu

212-844-8811

Remington-Davis, Inc., Columbus, Ohio

Status

Recruiting

Address

Remington-Davis, Inc.

Columbus, Ohio, 43215

Site Contact

Heather Lee, NP

hlee@remdavis.com

614-487-2560

DermDox, Sugarloaf, Pennsylvania

Status

Recruiting

Address

DermDox

Sugarloaf, Pennsylvania, 18249

Site Contact

Suzy Keagy

suzy.keagy@yahoo.com

717-439-6900

CRCC, Charleston, South Carolina

Status

Recruiting

Address

CRCC

Charleston, South Carolina, 29407

Site Contact

Gina Gregory

gina.gregory@dermandlaser.com

854-333-5455

Derm Research, Austin, Texas

Status

Recruiting

Address

Derm Research

Austin, Texas, 78759

Site Contact

Jeremiah Foretenberry

jeremiah@vialtrials.com

512-349-9889

Studies in Dermatology, LLC, Cypress, Texas

Status

Recruiting

Address

Studies in Dermatology, LLC

Cypress, Texas, 77433

Austin Institute for Clinical Research, Pflugerville, Texas

Status

Recruiting

Address

Austin Institute for Clinical Research

Pflugerville, Texas, 78660

Site Contact

Alivia Hernandez

ahernandez@atxresearch.com

512-279-2545 #774

San Antonio, Texas

Status

Recruiting

Address

Progressive Clinical Research Group, Inc.

San Antonio, Texas, 78213

Site Contact

Amber Rogers

arogers@progclin.com

210-614-5557

Acclaim, Sugar Land, Texas

Status

Recruiting

Address

Acclaim

Sugar Land, Texas, 77479

Site Contact

Carina Espinoza

research@acclaimderm.com

832-770-6388 #106

Premier Clinical Research, Spokane, Washington

Status

Recruiting

Address

Premier Clinical Research

Spokane, Washington, 99202

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