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

Sunshine Guojian Pharmaceutical

Status and phase: Enrolling; Phase 3

Conditions: Ankylosing Spondylitis

Treatments: Drug: Placebo; Drug: 608 dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT07261644

SSGJ-608-AS-III-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Able to understand and comply with the protocol requirements, participate and sign the informed consent form (ICF) voluntarily;
2. At least 18 years of age at the time of signing the ICF, with no gender restrictions;
3. Meet the 1984 modified New York criteria for ankylosing spondylitis (AS);
4. Have inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs) or have contraindications/intolerance to NSAIDs treatment;
5. 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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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500 participants in 2 patient groups, including a placebo group

608 Dose

Experimental group

Description:

608 subcutaneous (SC) injection.

Treatment:

Drug: 608 dose

Placebo

Placebo Comparator group

Description:

Placebo subcutaneous (SC) injection.

Treatment:

Drug: Placebo