A Study to Evaluate Efficacy and Safety of HS-10374 for Moderate to Severe Plaque Psoriasis

Hansoh Pharma

Status and phase: Enrolling; Phase 2

Conditions: Psoriasis

Treatments: Drug: HS-10374 tablets 1mg; Drug: HS-10374-matched placebo tablets; Drug: HS-10374 tablets 5mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT06077331

HS-10374-201

Details and patient eligibility

About

This study has been designed to explore the clinical efficacy and safety of HS-10374 in the treatment of moderate to severe plaque psoriasis. Additionally, this study is to find the optimal dosing for the future clinical development of HS-10374.

Full description

This is a 12-week, multi-center, randomized, double blind, placebo-controlled, Phase 2 study. The study duration includes a 4-week screening period, a 12-week treatment period, and a 4-week follow-up period. All eligible subjects will be randomly assigned to 1 of 3 treatment arms (HS-10374 Dose 1, HS-10374 Dose 2, and placebo) in an equal ratio.

Enrollment: 120 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. Eligible for phototherapy or systemic therapy
4. Plaque covering ≥ 10% of BSA
5. PASI ≥ 12, sPGA ≥3

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. History of lack of response to any therapeutic agent targeted to IL-12, IL-17 or IL-23 at approved doses after at least 3 months of therapy
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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120 participants in 3 patient groups

HS-10374 Dose 1

Experimental group

Treatment:

Drug: HS-10374-matched placebo tablets

Drug: HS-10374 tablets 5mg

Drug: HS-10374 tablets 1mg

HS-10374 Dose 2

Experimental group

Treatment:

Drug: HS-10374 tablets 5mg

Drug: HS-10374 tablets 1mg

Placebo

Active Comparator group

Treatment:

Drug: HS-10374-matched placebo tablets