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

Hansoh Pharma

Status and phase: Not yet enrolling; Phase 3

Conditions: Psoriasis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06672393

HS-10374-301

Details and patient eligibility

About

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

Full description

This is a 52-week, multi-center, randomized, double-blind, placebo-controlled, Phase 3 study. The study duration includes a 4-week screening period, a 16-week placebo-controlled treatment period, a 36-week study drug treatment period, and a 4-week follow-up period. All eligible subjects will be randomly assigned in a 2:1 ratio to receive HS-10374 or placebo QD. At Week 16, subjects receiving placebo will be switched to HS-10374 QD.

Enrollment: 375 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female subjects aged 18 years and older
• Diagnosis of plaque psoriasis for at least 6 months
• Eligible for phototherapy or systemic therapy
• Plaque covering ≥ 10% of BSA
• PASI ≥ 12, sPGA ≥3

Exclusion criteria

• Diagnosis of non-plaque psoriasis or drug-induced psoriasis
• Recent history of infection, history or risk of serious infection
• Any major illness or evidence of unstable condition of major organ systems including psychiatric disease
• Any condition possibly affecting the PK process of the study drug
• Evidence of other skin conditions that would interfere with the evaluation of psoriasis
• History of hypersensitivity to the ingredients of study drugs, history of anaphylaxis
• Prior exposure to TYK2 inhibitors
• Have received the prohibited treatment during the protocol required washout period
• 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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375 participants in 2 patient groups, including a placebo group

HS-10374

Experimental group

Description:

Subjects will receive HS-10374 from Week 0 through Week 52.

Treatment:

Drug: HS-10374 6mg tablets

Placebo

Placebo Comparator group

Description:

Subjects will receive HS-10374 matching placebo from Week 0 through Week 16, and HS-10374 from Week 16 through Week 52.

Treatment:

Drug: HS-10374-matched placebo tablets

Drug: HS-10374 6mg tablets