Efficacy and Safety of HS-10374 Compared to Placebo in Adults With Active Psoriatic Arthritis

Sponsor
Hansoh BioMedical R&D Company
Study ID
NCT06176508
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • HS-10374 — DRUG
    Administered orally QD for 16 weeks
  • HS-10374-matched placebo tablets — DRUG
    Administered orally QD for 16 weeks
  • Tofacitinib 5Mg Tab,Oral — DRUG
    Administered orally BID for 16 weeks

Study Details

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

Key Dates

Start date
Feb 26, 2024
Status verified
Jul 2024
Primary completion
Apr 28, 2026
Completion
Aug 28, 2026

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HS-10374 Dose 1
  • Experimental: HS-10374 Dose 2
  • Placebo Comparator: Placebo
  • Active Comparator: tofacitinib

Primary Outcome Measure

Proportion of participants meeting American College of Rheumatology improvement of 20% (ACR20) response at Week 16 [ Time Frame: At week 16 ]

Central Contacts

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