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

Last updated: October 31, 2024
Sponsor: Hansoh BioMedical R&D Company
Overall Status: Active - Not Recruiting

Phase

3

Condition

Rosacea

Warts

Rash

Treatment

HS-10374-matched placebo tablets

HS-10374 6mg tablets

Clinical Study ID

NCT06672393
HS-10374-301
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

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 includingpsychiatric disease

  • Any condition possibly affecting the PK process of the study drug

  • Evidence of other skin conditions that would interfere with the evaluation ofpsoriasis

  • History of hypersensitivity to the ingredients of study drugs, history ofanaphylaxis

  • 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 subjectat unacceptable risk during this study period

Study Design

Total Participants: 375
Treatment Group(s): 2
Primary Treatment: HS-10374-matched placebo tablets
Phase: 3
Study Start date:
November 04, 2024
Estimated Completion Date:
June 29, 2026

Study 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.

Connect with a study center

  • Huashan Hospital affiliated to Fudan University

    Shanghai, Shanghai
    China

    Site Not Available

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