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NCT06077331 | RECRUITING | Psoriasis

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

Hansoh BioMedical R&D Company

Brief Summary:

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.

Condition or disease

Psoriasis

Intervention/treatment

HS-10374 tablets 1mg

HS-10374 tablets 5mg

HS-10374-matched placebo tablets

Phase

PHASE2

Detailed 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 120 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : A Multi-Center, Randomized, Double Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of HS-10374 in Adult Subjects With Moderate To Severe Plaque Psoriasis
Actual Study Start Date : 2023-09-28
Estimated Primary Completion Date : 2024-07-31
Estimated Study Completion Date : 2024-08-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
A Study to Evaluate Efficacy and Safety of HS-10374 for Moderate to Severe Plaque Psoriasis

Location Details

NCT06077331

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How to Participate

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Locations

RECRUITING

China, Shanghai

Huashan Hospital of Fudan University

Shanghai, Shanghai, China, 200040