NCT06833112Not yet recruitingPhase 4
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
Source: ClinicalTrials.gov · Last updated 18 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The aim of the study is to investigate the efficacy and safety of adalimumab in combination with secukinumab for the treatment of ankylosing spondylitis.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 22 Jan 2025
- Start date
- Feb 2025
- Primary completion date
- Aug 2027
- Lead sponsor
- The Affiliated Hospital Of Guizhou Medical University
- Diseases
- Ankylosing spondylitis
- NCT number
- NCT06833112
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 10
- From Feb 2025 to the primary completion date, Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects who are participating in clinical research of other drugs;
Other illness
- With unstable vital signs, coma, mental and cognitive impairment;
- Patients with severe systemic diseases and other serious chronic diseases;
- History of malignant tumor in the past 5 years;
- Positive test for the following infection markers: human immunodeficiency virus (HIV), hepatitis B, hepatitis C, syphilis antibody;
- Patients with active or recurrent history of infection; With active tuberculosis or have a history of active tuberculosis in the past;
- Moderate to severe heart failure (New York Heart Association grade 3-4);
- Allergic to any of the components of adalimumab (HS016) or secukinumab;
Other
- Pregnant or lactating patients;
- In addition to the above, the investigator judged that there are other reasons that are not suitable for participating in this clinical study.
Who the study is looking for
- Male or female at least 18 years old;
- diagnosed with AS according to the 1984 New York Modified Criteria;
- Poor response after at least 2 NSAIDs (cumulative treatment ≥ 4 weeks), or contraindication or intolerance to NSAIDs therapy;
- BASDAI score of ≥ 4 and total back pain VAS score of ≥ 4 at baseline;
- 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;
- Voluntary treatment with adalimumab and secukinumab;
- Appropriate contraceptive measures for women of childbearing age;
- without other rheumatic diseases.
- Able to understand study requirements, provide written informed consent, and comply with trial protocol procedures (including required visits)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Affiliated Hospital of Guizhou Medical University Coordinator of this site? Confirm its status | Guiyang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.