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RECRUITINGPHASE3

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

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)

NCT07261644•Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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.

Locations (1)

Site 01

Beijing, Beijing Municipality, China

Key Dates

Start Date

November 7, 2025

Primary Completion Date

January 14, 2027

Completion Date

November 18, 2027

Last Updated

December 10, 2025

Enrollment

500

ESTIMATED participants

Conditions

Ankylosing Spondylitis

Interventions

608 dose

DRUG

Placebo

DRUG

Contacts

Qing hong Zhou

CONTACT

+86 18911301578 zhouqinghong@3sbio.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Rheumatology Patient Registry and Biorepository

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