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

Hangzhou Highlightll Pharmaceutical

Status and phase: Enrolling; Phase 2

Conditions: Plaque Psoriasis

Treatments: Drug: TLL018 tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT05772520

TLL018-205

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

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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) ....

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 4 patient groups, including a placebo group

Cohort 1

Experimental group

Description:

TLL018 tables, 10 mg 1piece,BID

Treatment:

Drug: TLL018 tablets

Cohort 2

Experimental group

Description:

TLL018 tables, 20 mg 1piece,BID

Treatment:

Drug: TLL018 tablets

Cohort 3

Experimental group

Description:

TLL018 tables, 40 mg 1piece,BID

Treatment:

Drug: TLL018 tablets

Cohort 4

Placebo Comparator group

Description:

placebo, 1piece,BID

Treatment:

Drug: TLL018 tablets