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Unknown

TLL018 Tablets for Plaque Psoriasis

Phase 2
Recruiting
Research Sponsored by Hangzhou Highlightll Pharmaceutical Co., Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age between 18 and 75 years at time of informed consent
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from week 4 to weeks 12(except week 12)
Awards & highlights

Study Summary

This trial tests if a drug is safe and effective for people with severe skin conditions.

Who is the study for?
Adults aged 18-75 with a BMI of 18.0 to 35.0, diagnosed with moderate-to-severe plaque psoriasis covering at least 10% body surface for over six months can join this trial. They must have certain severity scores and be able to follow the study rules but cannot participate if pregnant, nursing, or have recent substance abuse history, significant infections, hepatitis B/C, HIV, TB exposure or other autoimmune diseases (except psoriatic arthritis).Check my eligibility
What is being tested?
The trial is testing TLL018 tablets' effectiveness and safety in treating moderate-to-severe plaque psoriasis compared to a placebo. It's a Phase 2 study where participants are randomly assigned into groups receiving different doses of TLL018 or placebo without knowing which one they're getting.See study design
What are the potential side effects?
While specific side effects for TLL018 aren't listed here, common side effects for treatments like these may include skin reactions at the site of treatment, gastrointestinal issues such as nausea or diarrhea, potential liver function changes and an increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 75 years old.
Select...
My psoriasis covers more than 10% of my body and is moderately to severely severe.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from week 4 to weeks 12(except week 12)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from week 4 to weeks 12(except week 12) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
proportion of participants achieving PASI-75
Secondary outcome measures
Proportion of participants achieving PASI-75 (except Week 12)
Proportion of participants achieving PASI-90
Proportion of participants achieving PGA score of 0 or 1

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Cohort 3Experimental Treatment1 Intervention
TLL018 tables, 40 mg 1piece,BID
Group II: Cohort 2Experimental Treatment1 Intervention
TLL018 tables, 20 mg 1piece,BID
Group III: Cohort 1Experimental Treatment1 Intervention
TLL018 tables, 10 mg 1piece,BID
Group IV: Cohort 4Placebo Group1 Intervention
placebo, 1piece,BID
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TLL018 tablets
2022
Completed Phase 1
~120

Find a Location

Who is running the clinical trial?

Hangzhou Highlightll Pharmaceutical Co., LtdLead Sponsor
6 Previous Clinical Trials
693 Total Patients Enrolled

Media Library

TLL018 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05772520 — Phase 2
Plaque Psoriasis Research Study Groups: Cohort 4, Cohort 2, Cohort 3, Cohort 1
Plaque Psoriasis Clinical Trial 2023: TLL018 Highlights & Side Effects. Trial Name: NCT05772520 — Phase 2
TLL018 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05772520 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants of this research endeavor above the age of 25 being considered?

"This research is only open to individuals aged 18-75. There are 32 clinical trials available for minors and 138 studies that cater to elderly participants."

Answered by AI

What health risks might be posed to individuals participating in Cohort 1?

"Taking into account the fact that this is a Phase 2 trial and there is supportive data for safety but not efficacy, our team has rated Cohort 1's security as a score of 2."

Answered by AI

How many individuals have enrolled in this clinical experiment?

"Yes, the information available on clinicaltrials.gov specifies that this medical study is currently open for recruitment. The trial was first published on January 19th 2023 and last modified on March 6th 2023; with a requirement of 120 participants from one site."

Answered by AI

What qualifications must an individual meet to participate in the research project?

"To qualify for this trial, individuals should exhibit symptoms of plaque psoriasis and be between the ages 18-75. A total of 120 participants are needed to complete this study."

Answered by AI

Is enrollment for this experimental program available presently?

"Affirmative. According to clinicaltrials.gov, this investigation is currently seeking participants after being first posted on January 19th 2023 and most recently updated on March 6th of the same year. One hundred twenty individuals are required for the trial from one location only."

Answered by AI

Who else is applying?

What site did they apply to?
Life Clinical Trials
Skin Surgical
Mount Sinai
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Mount Sinai: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
The Efficacy and Safety of TLL018 in Moderate-to-severe Plaque Psoriasis
2023. "The Efficacy and Safety of TLL018 in Moderate-to-severe Plaque Psoriasis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05772520.
All > Psoriasis > Spokane
~53 spots leftby Apr 2025
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