Clinical trial NCT06833112: Interleukin-17 (IL-17) Inhibitor in Combination With Tumor Necrosis Factor α (TNFα )Inhibitor for the Treatment of Ankylosing Spondylitis
Official title: Efficacy and Safety of Interleukin-17 Inhibitor in Combination With Tumor Necrosis Factor α Inhibitor in the Treatment of Ankylosing Spondylitis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Ankylosing Spondylitis
Keywords: ankylosing spondylitis
Secukinumab
adalimumab
Lead sponsor: The Affiliated Hospital Of Guizhou Medical University
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to investigate the efficacy and safety of adalimumab in combination with secukinumab for the treatment of ankylosing spondylitis.


Eligibility criteria: Inclusion Criteria:

1. Male or female at least 18 years old;
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:

1. With unstable vital signs, coma, mental and cognitive impairment;
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.

Primary outcomes:
measure: Assessment of SpondyloArthritis International Society 40 (ASAS 40)
timeFrame: week 52
measure: ASAS40
timeFrame: week 104
measure: Modified Stoke Ankylosing Spondylitis Spine Score (mSASSS)
timeFrame: week 104
measure: Spondyloarthritis Research Consortium of Canada (SPARCC)
timeFrame: week 104
Secondary outcomes:
measure: Assessment of SpondyloArthritis International Society 20 (ASAS20)
timeFrame: week 12, week 24, week 52
measure: Assessment of SpondyloArthritis International Society 5/6 (ASAS5/6)
timeFrame: week 12, week 24, week 52
measure: Assessment in Ankylosing Spondylitis international Society Partial Release (ASAS PR)
timeFrame: week 12, week 24, week 52
measure: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50
timeFrame: week 12, week 24, week 52
measure: BASDAI
timeFrame: week 12, week 24, week 52
measure: Bath Ankylosing Spondylitis Functional Index (BASFI)
timeFrame: week 12, week 24, week 52
measure: Visual Analogue Scale (VAS)
timeFrame: week 12, week 24, week 52
measure: Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)
timeFrame: week 12, week 24, week 52
measure: tender joint count (TJC), swollen joint count(SJC)
timeFrame: week 12, week 24, week 52
measure: Ankylosing Spondylitis Disease Activity Score based on C-reactive Protein (ASDAS-CRP)
timeFrame: week 12, week 24, week 52
measure: Ankylosing Spondylitis Disease Activity Score based on Erythrocyte Sedimentation Rate (ASDAS-ESR)
timeFrame: week 12, week 24, week 52
measure: Ankylosing Spondylitis Quality of Life (ASQoL)
timeFrame: week 12, week 24, week 52
measure: Adverse event (AE)
timeFrame: week 12, week 24, week 52，week 104
Other outcomes:
Locations:
city: Guiyang
country: China
facility: The Affiliated Hospital of Guizhou Medical University
state: Guizhou
Study officials:
affiliation: The Affiliated Hospital Of Guizhou Medical University
name: Jiashun Zeng, Medical Doctor
role: PRINCIPAL_INVESTIGATOR
References: