TLL018 Tablets for Plaque Psoriasis

Recruiting in Palo Alto (17 mi)

+36 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Hangzhou Highlightll Pharmaceutical Co., Ltd

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This is a Phase 2, multicenter, randomized, double-blinded, parallel dose group, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of 2 doses of TLL018 as therapy in approximately 90 participants with moderate-to-severe PP.

Research Team

Eligibility Criteria

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).

Inclusion Criteria

Your BMI lies between 18.0 and 35.0 kg/m2, inclusive.

I have had moderate-to-severe plaque psoriasis for at least 6 months.

I am between 18 and 75 years old.

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Exclusion Criteria

You have a history of alcohol or drug abuse in the last 6 months before screening.

I do not have any severe or worsening health issues affecting my kidneys, liver, blood, stomach, hormones, lungs, heart, brain, or mental health.

I have no cancer history, except possibly cured skin or early cervical cancer.

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Treatment Details

Interventions

TLL018 (Unknown)

Trial OverviewThe 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.

Participant Groups

3Treatment groups

Experimental Treatment

Group I: Cohort 4Experimental Treatment1 Intervention

placebo, 1piece,BID

Group II: Cohort 3Experimental Treatment1 Intervention

TLL018 tables, 40 mg 1piece,BID

Group III: Cohort 2Experimental Treatment1 Intervention

TLL018 tables, 20 mg 1piece,BID