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TLL018-205 Enrolling

Plaque Psoriasis Clinical Trial – Moderate-to-Severe (4 Months)


Treatment: Oral Age: 18 Years


Recruiting adults 18-75 years of age with a diagnosis of plaque psoriasis for a clinical trial. Eligible candidates must have a diagnosis of moderate-to-severe plaque psoriasis covering 10% or more of their body surface area (BSA) for the past 6 months or more, but not other forms of psoriasis.  A body mass index (BMI) of 18.0 – 35.0 kg/m2 is also required. Participants who have not received systemic treatment for plaque psoriasis, or who have received at least one conventional anti-psoriasis treatment, may be eligible to participate.

Participants will receive investigational oral treatment (active study drug) or placebo during the treatment period. Study treatment and study-related assessments will be provided at no cost.  Reimbursement for study-related expenses may be provided.

Study participation will last about 4 months and involve about 8 visits to the study centre.


Participating Locations

COUNTRY
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United States

Participating Experts

Dr. James Wang

Dermatologist

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The following information is from ClinicalTrials.gov

Last Update Posted: February 25, 2024

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

ClinicalTrials.gov ID

NCT05772520

Sponsor

Hangzhou Highlightll Pharmaceutical Co., Ltd

Study Description

  • 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 3 doses of TLL018 as therapy in 120 participants with moderate-to-severe PP.

  • Condition or Disease:

    Plaque Psoriasis

  • Intervention/Treatment:

    Drug: TLL018 tablets
    Drug: TLL018 tablets
    Drug: TLL018 tablets
    Drug: TLL018 tablets
  • Phase:

    Phase 2

  • Ages Eligible for Study:

    18 Years and 75 Years (Adult)

  • Sexes Eligible for Study:

    All

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.
Body mass index (BMI) of 18.0 to 35.0 kg/m2inclusive.
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.
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. 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). 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. 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. 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) ....


Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.



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