The Efficacy and Safety of TLL018 in 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 3 doses of TLL018 as therapy in 120 participants with moderate-to-severe PP.
Conditions:
🦠 Plaque Psoriasis
🗓️ Study Start (Actual) 19 January 2023
🗓️ Primary Completion (Estimated) 1 April 2024
✅ Study Completion (Estimated) 31 May 2024
👥 Enrollment (Estimated) 120
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Birmingham, Alabama, United States
📍 Beverly Hills, California, United States
📍 Los Angeles, California, United States
📍 Sacramento, California, United States
📍 San Diego, California, United States
📍 Coral Springs, Florida, United States
📍 DeLand, Florida, United States
📍 Doral, Florida, United States
📍 Jacksonville, Florida, United States
📍 Lake Worth, Florida, United States
📍 Pembroke Pines, Florida, United States
📍 Des Moines, Iowa, United States
📍 Rockville, Maryland, United States
📍 Brighton, Massachusetts, United States
📍 Warren, Michigan, United States
📍 Troy, Missouri, United States
📍 New York, New York, United States
📍 Columbus, Ohio, United States
📍 Sugarloaf, Pennsylvania, United States
📍 Charleston, South Carolina, United States
📍 Austin, Texas, United States
📍 Cypress, Texas, United States
📍 Pflugerville, Texas, United States
📍 San Antonio, Texas, United States
📍 Sugar Land, Texas, United States
📍 Spokane, Washington, United States

📋 Eligibility Criteria

Description

    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) ....
Ages Eligible for Study: 18 Years to 75 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 6 March 2023
  • First Submitted that Met QC Criteria 6 March 2023
  • First Posted 16 March 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 20 September 2023
  • Last Update Posted 22 September 2023
  • Last Verified September 2023