A Study of the Efficacy and Safety of SHR-1314 for Adult Active Psoriatic Arthritis

Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study ID
NCT06640257
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SHR-1314 injection — DRUG
    SHR-1314 injection
  • Placebo — DRUG
    Placebo

Study Details

This study is a randomized, double-blind, multicenter, placebo-controlled Phase III clinical study, consisting of a 4-week screening period, a 24-week core treatment period, a 24-week maintenance treatment period, and an 8-week safety follow-up period. It is planned to include 150 adult subjects with psoriatic arthritis.

Key Dates

First listed
Oct 15, 2024
Start date
Nov 4, 2024
Status verified
Oct 2024
Primary completion
Apr 30, 2026
Completion
Jun 30, 2026

Study Design

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

Arms

  • Experimental: SHR-1314 injection
  • Placebo Comparator: placebo

Primary Outcome Measure

Proportion of subjects achieving ACR 20 improvement at week 24 [ Time Frame: Week 24 ]

Central Contacts

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Psoriatic arthritis trialsRheumatology trialsAutoimmune disease trialsMusculoskeletal disorders trials

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