A Study to Evaluate Efficacy and Safety of HS-10374 for Mild-to-moderate Plaque Psoriasis

Hansoh Pharma

Status and phase: Not yet enrolling; Phase 2

Conditions: Psoriasis

Treatments: Drug: HS-10374-matched placebo tablets; Drug: HS-10374 6mg tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT06926582

HS-10374-205

Details and patient eligibility

About

This study has been designed to explore the clinical efficacy and safety of HS-10374 in the treatment of mild-to-moderate plaque psoriasis.

Full description

This is a 12-week, multi-center, randomized, double-blind, placebo-controlled, Phase II study. The study duration includes a 4-week screening period, a 12-week placebo-controlled treatment period, and a 4-week follow-up period. All eligible subjects will be randomly assigned in a 2:2:1 ratio to receive HS-10374 Dose 1, HS-10374 Dose 2, or placebo.

Enrollment: 305 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female subjects between the ages of 18-70 years
2. Diagnosis of plaque psoriasis for at least 6 months
3. sPGA score of 2-3, BSA 2-15%, PASI score 2-15
4. Subject must be inadequately controlled with, or intolerant of at least one topical therapy

Exclusion criteria

1. Diagnosis of non-plaque psoriasis or drug-induced psoriasis
2. Recent history of infection, history or risk of serious infection
3. Any major illness or evidence of unstable condition of major organ systems including psychiatric disease
4. Any condition possibly affecting the PK process of the study drug
5. Evidence of other skin conditions that would interfere with the evaluation of psoriasis
6. History of hypersensitivity to the ingredients of study drugs, history of anaphylaxis
7. Prior exposure to TYK2 inhibitors
8. Have received the prohibited treatment during the protocol required washout period
9. Any significant laboratory or procedure abnormalities that might place the subject at unacceptable risk during this study period

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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305 participants in 3 patient groups, including a placebo group

HS-10374 Dose 1

Experimental group

Treatment:

Drug: HS-10374 6mg tablets

Drug: HS-10374-matched placebo tablets

HS-10374 Dose 2

Experimental group

Treatment:

Drug: HS-10374 6mg tablets

Placebo

Placebo Comparator group

Treatment:

Drug: HS-10374-matched placebo tablets