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

September 20, 2023 updated by: Hangzhou Highlightll Pharmaceutical Co., Ltd

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35244
    • California
      • Beverly Hills, California, United States, 90210
        • Recruiting
        • Moy, Fincher, Chipps
        • Contact:
        • Principal Investigator:
          • Ron Moy
      • Los Angeles, California, United States, 90017
        • Recruiting
        • Metropolis Derm
        • Contact:
        • Principal Investigator:
          • James Wang
      • Sacramento, California, United States, 95815
        • Recruiting
        • Integrative Skin
        • Contact:
        • Contact:
          • Yvonne Nong
          • Phone Number: 916-524-1216
        • Principal Investigator:
          • Raja Sivamani
      • San Diego, California, United States, 92117
        • Recruiting
        • Skin Surgical
        • Contact:
        • Principal Investigator:
          • Anne Truitt
    • Florida
      • Coral Springs, Florida, United States, 33071
        • Recruiting
        • Life Clinical Trials
        • Contact:
        • Contact:
          • Ruth Tecier:
          • Phone Number: 754-777-2714
        • Principal Investigator:
          • Eli Saleeby
        • Sub-Investigator:
          • Leeor Porges, DO
      • DeLand, Florida, United States, 33484
        • Recruiting
        • Palm Beach
        • Contact:
        • Contact:
          • Myesha Ponder
          • Phone Number: 561-559-1516
        • Principal Investigator:
          • Adam Plotkin
      • Doral, Florida, United States, 33122
        • Recruiting
        • D&H Doral Research Center LLC
        • Contact:
        • Contact:
        • Principal Investigator:
          • Anneyd M. Avalos
        • Sub-Investigator:
          • Anna Cury, MD
        • Sub-Investigator:
          • Brent M. Schillinger
      • Jacksonville, Florida, United States, 32256
        • Recruiting
        • CNS - Jacksonville
        • Contact:
        • Contact:
        • Principal Investigator:
          • Fadi Raji Chalhoub
        • Sub-Investigator:
          • Susan Angel, APRN
      • Lake Worth, Florida, United States, 33461
        • Recruiting
        • Altus Research
        • Principal Investigator:
          • Thomas Ross
        • Contact:
        • Contact:
          • Jim Goldberg
          • Phone Number: 561-641-0404
        • Sub-Investigator:
          • Samuel Lederman, MD
      • Pembroke Pines, Florida, United States, 33028
        • Withdrawn
        • AQUA - Riverchase
    • Iowa
      • Des Moines, Iowa, United States, 50265
        • Recruiting
        • Integrated Clinical Trial Services, Inc
        • Principal Investigator:
          • James Coggi
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Todd Treimer, DO
        • Sub-Investigator:
          • Mary Barkley, ARNP
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Recruiting
        • Lawrence Green
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lawrence Green
    • Massachusetts
      • Brighton, Massachusetts, United States, 02135
    • Michigan
    • Missouri
      • Troy, Missouri, United States, 48084
        • Recruiting
        • Revival Research Institute
        • Principal Investigator:
          • Ali Moiin
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Mohammad Zarka, DO
    • New York
    • Ohio
      • Columbus, Ohio, United States, 43215
        • Recruiting
        • Remington-Davis, Inc.
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michelle Chambers
        • Sub-Investigator:
          • Edward Cordasco, DO
    • Pennsylvania
      • Sugarloaf, Pennsylvania, United States, 18249
        • Recruiting
        • DermDox
        • Contact:
        • Contact:
        • Principal Investigator:
          • Stephen Schleicher
        • Sub-Investigator:
          • Zach Sabaday, PA
    • South Carolina
      • Charleston, South Carolina, United States, 29407
    • Texas
      • Austin, Texas, United States, 78759
        • Recruiting
        • Derm Research
        • Contact:
        • Contact:
        • Principal Investigator:
          • David Bushore
      • Cypress, Texas, United States, 77433
        • Recruiting
        • Studies in Dermatology, LLC
        • Contact:
        • Principal Investigator:
          • Lauren Campbell
        • Sub-Investigator:
          • Sharon R. Kim, MD
      • Pflugerville, Texas, United States, 78660
        • Recruiting
        • Austin Institute for Clinical Research
        • Principal Investigator:
          • Edward Lain
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Madeleine Gantz, MD
      • San Antonio, Texas, United States, 78213
        • Recruiting
        • Progressive Clinical Research Group, Inc.
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mark Lee
        • Sub-Investigator:
          • Theresia Lee, MD
      • Sugar Land, Texas, United States, 77479
        • Recruiting
        • Acclaim
        • Contact:
        • Principal Investigator:
          • Syed Ali
    • Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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) ....

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
TLL018 tables, 10 mg 1piece,BID
Drug: TLL018 tablets
oral tablets administered BID for 12weeks
Other Names:
  • TLL018 Placeboes
Experimental: Cohort 2
TLL018 tables, 20 mg 1piece,BID
Drug: TLL018 tablets
oral tablets administered BID for 12weeks
Other Names:
  • TLL018 Placeboes
Experimental: Cohort 3
TLL018 tables, 40 mg 1piece,BID
Drug: TLL018 tablets
oral tablets administered BID for 12weeks
Other Names:
  • TLL018 Placeboes
Placebo Comparator: Cohort 4
placebo, 1piece,BID
Drug: TLL018 tablets
oral tablets administered BID for 12weeks
Other Names:
  • TLL018 Placeboes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
proportion of participants achieving PASI-75
Time Frame: Week12

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants achieving PGA score of 0 or 1
Time Frame: From week 4 to Weeks 12
A patient was a responser if PGA score of 0 or 1 condition was reached, as listed: (0 Clear) No signs of psoriasis, but post-inflammatory discoloration may be present; (1 Almost clear): Only minimal plaque elevation, scaling, and erythema.
From week 4 to Weeks 12
Proportion of participants achieving PASI-75 (except Week 12)
Time Frame: From week 4 to Weeks 12(except Week 12)

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
From week 4 to Weeks 12(except Week 12)
Proportion of participants achieving PASI-90
Time Frame: From week 4 to Weeks 12

A patient was a responser if a minimum 90% 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
From week 4 to Weeks 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hangzhou Highlightll Pharmaceutical Co., Ltd

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 Major Dates

Study Start (Actual)

January 19, 2023

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

May 31, 2024

Study Registration Dates

First Submitted

March 6, 2023

First Submitted That Met QC Criteria

March 6, 2023

First Posted (Actual)

March 16, 2023

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 20, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TLL018-205

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Plaque Psoriasis

Clinical Trials on TLL018 tablets

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Benin

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe