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

Last updated: November 30, 2023
Sponsor: Hansoh BioMedical R&D Company
Overall Status: Active - Recruiting

Phase

2

Condition

Warts

Rosacea

Scalp Disorders

Treatment

HS-10374-matched placebo tablets

HS-10374 tablets 1mg

HS-10374 tablets 5mg

Clinical Study ID

NCT06077331
HS-10374-201
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 includingpsychiatric 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 ofpsoriasis
  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-23at 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 atunacceptable risk during this study period

Study Design

Total Participants: 120
Treatment Group(s): 3
Primary Treatment: HS-10374-matched placebo tablets
Phase: 2
Study Start date:
September 28, 2023
Estimated Completion Date:
August 31, 2024

Study 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.

Connect with a study center

  • Huashan Hospital of Fudan University

    Shanghai, Shanghai 200040
    China

    Active - Recruiting

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