Interleukin-17 (IL-17) Inhibitor in Combination With Tumor Necrosis Factor α (TNFα )Inhibitor for the Treatment of Ankylosing Spondylitis
NCT ID: NCT06833112
Last Updated: 2025-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
10 participants
INTERVENTIONAL
2025-02-28
2028-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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treatment group
The subjects were treated with adalimumab (HS016) in combination with secukinumab
Secukinumab
The subjects were treated with secukinumab for 104 weeks. Secukinumab:150mg，q8w，subcutaneous injection.
Adalimumab
The subjects were treated with adalimumab for 104 weeks. adalimumab: 40mg，q4w，subcutaneous injection.
Interventions
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Secukinumab
The subjects were treated with secukinumab for 104 weeks. Secukinumab:150mg，q8w，subcutaneous injection.
Adalimumab
The subjects were treated with adalimumab for 104 weeks. adalimumab: 40mg，q4w，subcutaneous injection.
Eligibility Criteria
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Inclusion Criteria
2. diagnosed with AS according to the 1984 New York Modified Criteria;
3. Poor response after at least 2 NSAIDs (cumulative treatment ≥ 4 weeks), or contraindication or intolerance to NSAIDs therapy;
4. BASDAI score of ≥ 4 and total back pain VAS score of ≥ 4 at baseline;
5. Subjects who need to take NSAIDs (including COX-1 or COX-2 inhibitors) as established treatment for AS, and the NSAIDs should be on a stable dose for at least 2 weeks (inclusive) before screening and the dose is expected to be stable during the study;
6. Voluntary treatment with adalimumab and secukinumab;
7. Appropriate contraceptive measures for women of childbearing age;
8. without other rheumatic diseases.
9. Able to understand study requirements, provide written informed consent, and comply with trial protocol procedures (including required visits)
Exclusion Criteria
2. Patients with severe systemic diseases and other serious chronic diseases;
3. Pregnant or lactating patients;
4. History of malignant tumor in the past 5 years;
5. Positive test for the following infection markers: human immunodeficiency virus (HIV), hepatitis B, hepatitis C, syphilis antibody;
6. Patients with active or recurrent history of infection; With active tuberculosis or have a history of active tuberculosis in the past;
7. Moderate to severe heart failure (New York Heart Association grade 3-4);
8. Allergic to any of the components of adalimumab (HS016) or secukinumab;
9. Subjects who are participating in clinical research of other drugs;
10. In addition to the above, the investigator judged that there are other reasons that are not suitable for participating in this clinical study.
18 Years
ALL
No
Sponsors
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The Affiliated Hospital Of Guizhou Medical University
OTHER
Responsible Party
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Principal Investigators
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Jiashun Zeng, Medical Doctor
Role: PRINCIPAL_INVESTIGATOR
The Affiliated Hospital Of Guizhou Medical University
Locations
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The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024114K
Identifier Type: -
Identifier Source: org_study_id
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