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Recruiting NCT07261644

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

Phase III Interventional Ankylosing Spondylitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 608 dose, Placebo.
Who it may be relevant to
Registry conditions: Ankylosing Spondylitis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of 608 in Adult Subjects With Active Ankylosing Spondylitis (AS)

Overview

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

Detailed description

The purpose of this trial is to demonstrate the clinical efficacy at week 16; and to demonstrate safety and tolerability of 608 compared to placebo in patients with ankylosing spondylitis at week 16 and long term safety up to Week 60.

Interventions

  • Drug 608 dose
    608 subcutaneous (SC) injection.
  • Drug Placebo
    Placebo subcutaneous (SC) injection.

Primary outcome measures

  • The Percentage of Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 40 Response. [Time frame: Week 16.]
Secondary outcome measures (1)
  • The Percentage of Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 20 Response. [Time frame: Week 16.]

Eligibility criteria

Inclusion criteria

  • Able to understand and comply with the protocol requirements, participate and sign the informed consent form (ICF) voluntarily;
  • At least 18 years of age at the time of signing the ICF, with no gender restrictions;
  • Meet the 1984 modified New York criteria for ankylosing spondylitis (AS);
  • Have inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs) or have contraindications/intolerance to NSAIDs treatment;
  • Willing to practice contraception and have no plans for pregnancy, sperm donation, or egg donation from the screening period until at least 6 months after the last dose.

Exclusion criteria

  • Patients with other uncontrolled active inflammatory diseases.
  • Clinical laboratory tests and other tests that reveal abnormalities with clinical significance
  • Patients who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
  • History of cancer.
  • Known or suspected history of immunosuppression.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Site 01 — Beijing

Identifiers

NCT: NCT07261644 · SSGJ-608-AS-III-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗