A Study to Evaluate 608 in Patients with Ankylosing Spondylitis (AS)

Sponsor
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Study ID
NCT06242652
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • 608 Dose A — DRUG
    608 subcutaneous (SC) injection.
  • 608 Dose B — DRUG
    608 subcutaneous (SC) injection.
  • 608 Dose C — DRUG
    608 subcutaneous (SC) injection.
  • Adalimumab — DRUG
    Adalimumab subcutaneous (SC) injection.
  • Placebo — DRUG
    Placebo subcutaneous (SC) injection.

Study Details

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

Key Dates

Start date
Mar 19, 2024
Status verified
Feb 2024
Primary completion
Feb 27, 2025
Completion
Jun 15, 2025

Study Design

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

Arms

  • Experimental: 608 Dose A
    608 Dose A subcutaneous (SC) injection.
  • Experimental: 608 Dose B
    608 Dose B subcutaneous (SC) injection.
  • Experimental: 608 Dose C
    608 Dose C subcutaneous (SC) injection.
  • Active Comparator: Positive control group
    Adalimumab 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) 20 Response. [ Time Frame: Week 16. ]

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