Clinical trial · Interventional
Interleukin-17 (IL-17) Inhibitor in Combination With Tumor Necrosis Factor α (TNFα )Inhibitor for the Treatment of Ankylosing Spondylitis
Efficacy and Safety of Interleukin-17 Inhibitor in Combination With Tumor Necrosis Factor α Inhibitor in the Treatment of Ankylosing Spondylitis
NCT06833112CI-TRIAL-00086166not yet recruitingPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of the study is to investigate the efficacy and safety of adalimumab in combination with secukinumab for the treatment of ankylosing spondylitis.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ankylosing Spondylitis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adalimumab | Drug | — | UNRESOLVED |
| Secukinumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- treatment group
- description
- The subjects were treated with adalimumab (HS016) in combination with secukinumab
- interventionNames
- Drug: Secukinumab
- Drug: Adalimumab
Primary outcomes (4)
- measure
- Assessment of SpondyloArthritis International Society 40 (ASAS 40)
- timeFrame
- week 52
- description
- Proportion of subjects achieving ASAS 40 at Week 52. ASAS 40 is a response criterion used to evaluate the effectiveness of treatments in patients with ankylosing spondylitis. It measures the percentage of patients who achieve at least a 40% improvement in disease activity. Key Components of ASAS40: * Patient Global Assessment:Patient's overall assessment of disease activity * Pain: Assessment of spinal pain. * Function: Measured by the Bath Ankylosing Spondylitis Functional Index (BASFI). * Inflammation: Based on morning stiffness severity and duration. Calculation: A patient is considered an ASAS40 responder if they achieve at least a 40% improvement or an absolute improvement of ≥2 units (on a 0-10 scale) in at least 3 out of 4 domains, with no worsening in the remaining domain.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.