A Study to Evaluate the Efficacy and Safety of 608 in Adult Subjects With Active Ankylosing Spondylitis(AS)

Sponsor
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Study ID
NCT07261644
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • 608 dose — DRUG
    608 subcutaneous (SC) injection.
  • Placebo — DRUG
    Placebo subcutaneous (SC) injection.

Study Details

This study will evaluate the efficacy and safety of 608 in patients with AS.

Key Dates

Start date
Nov 7, 2025
Status verified
Dec 2025
Primary completion
Jan 14, 2027
Completion
Nov 18, 2027

Study Design

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

Arms

  • Experimental: 608 Dose
    608 subcutaneous (SC) injection.
  • Placebo Comparator: Placebo
    Placebo subcutaneous (SC) injection.

Primary Outcome Measure

The Percentage of Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 40 Response. [ Time Frame: Week 16. ]

Central Contacts

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