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NCT04957550

To Evaluate the Efficacy and Safety of SHR0302 Tablet in Subjects of Active Psoriatic Arthritis

StatusActive, Not Recruiting
PhasePhase 3
Primary completion (estimated)
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Record History

All 4 versions: 4 with changes below.

  1. Primary and study completion dates: Nov 13, 2024 to Dec 13, 2026
    • Trial status: Enrolling by Invitation to Active, Not Recruiting
    • Enrollment target: estimated 444 to confirmed 418
    v4
  2. Trial status: Recruiting to Enrolling by Invitation
    • Site details revised
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Nov 13, 2023 to Nov 13, 2024
    • Start date changed from estimate of Aug 5, 2021 to Aug 30, 2021
    • Site details revised
    v2
  4. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

ACR20 response rate at week 24
Timeframe: Week 24

Secondary (3)

ACR20 response rate at week 48
ACR50/70 response rate at week 24 and week 48
Change from baseline in DAS28-CRP week 24 and week 48

Arms and interventions

Treatment group AExperimental

SHR0302 tablets dose 1+ Placebo dose 2

Treatment group BExperimental

SHR0302 tablets dose 2+ Placebo dose 1

Treatment group CPlacebo comparator

Placebo dose1 + placebo dose 2

Drugs: SHR0302 tablets、Placebo, Placebo

Sites

1 site in 1 country

  • Peking University HospitalBeijing, Beijing Municipality, China