In short
There are currently 2 ongoing clinical trials for ankylosing spondylitis, a type of inflammatory arthritis that primarily affects the spine. These trials are testing different medications to help reduce pain, inflammation, and other symptoms associated with this condition. The studies are being conducted across multiple European countries and aim to evaluate both the effectiveness and long-term safety of the treatments being investigated.
Clinical trial locations
- Belgium
- Bulgaria
- Czechia
- France
- Germany
- Hungary
- Italy
- Poland
- Portugal
- Slovakia
- Spain
Study on Long-Term Safety of Secukinumab for Patients with Psoriatic Arthritis, Ankylosing Spondylitis, and Severe Chronic Plaque Psoriasis
This trial is evaluating the long-term safety of secukinumab, a medication administered through subcutaneous injections (under the skin). The study is specifically designed for patients who have already participated in a previous secukinumab trial and are believed to benefit from continued treatment.
Main inclusion criteria: To participate, you must provide signed informed consent. If you are under 18, written parental permission is required. You must have completed a previous Novartis study involving secukinumab and be currently benefiting from the treatment. Your study doctor must believe that continuing secukinumab will provide more benefits than risks. Additionally, you must not have access to secukinumab through local prescription or standard healthcare coverage.
Main exclusion criteria: Despite the trial's name, the exclusion criteria list several conditions that cannot participate, including psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, severe chronic plaque psoriasis, moderate to severe chronic plaque psoriasis, and juvenile idiopathic arthritis. This appears to be a data inconsistency in the source material.
Focus of the trial: The study will monitor participants for up to 104 weeks to assess the long-term safety of secukinumab. Healthcare professionals will closely observe any serious adverse events or unwanted effects that may occur during treatment. Regular check-ups are scheduled to assess your response to treatment and ensure your safety throughout the study period.
Investigational drug: Secukinumab works by blocking a specific protein called interleukin-17A, which plays a role in inflammation and immune response in the body. By targeting this protein, the medication aims to reduce symptoms like redness, swelling, and pain associated with inflammatory conditions.
Study on Upadacitinib for Adults with Active Axial Spondyloarthritis
This trial is studying the effects of upadacitinib on axial spondyloarthritis, which includes both ankylosing spondylitis and non-radiographic axial spondyloarthritis. The study is designed as a double-blind trial, meaning neither participants nor researchers will know who receives the actual medication versus a placebo (an inactive substance).
Main inclusion criteria: Participants must be at least 18 years old and willing to keep their current medications stable during the study. You must understand and agree to follow all study requirements and sign an approved consent form. For Study 1, you must have a clinical diagnosis of ankylosing spondylitis meeting specific criteria and have previously tried 1 or 2 biologic medications (including at least one TNF inhibitor or IL-17 inhibitor) that did not work well or caused intolerance. For Study 2, you must have non-radiographic axial spondyloarthritis with signs of active inflammation on an MRI scan or elevated CRP levels in your blood. Participants must also have specific symptom scores indicating active disease.
Main exclusion criteria: You cannot participate if you have a history of severe allergic reactions to the study medication, active infections such as tuberculosis, cancer within the last 5 years (except certain skin cancers), liver disease or abnormal liver function, certain blood disorders like low white blood cell count, or if you are pregnant or breastfeeding. Those with a history of drug or alcohol abuse within the past year are also excluded, as are patients who have received certain treatments within specific timeframes before the study begins.
Focus of the trial: The study aims to evaluate how well upadacitinib works in reducing the signs and symptoms of axial spondyloarthritis compared to placebo. Participants will be monitored through regular check-ups that may include physical exams, questionnaires, and blood tests. The trial also includes a remission-withdrawal period for those who respond well to treatment, to observe if they can maintain improvement over time.
Investigational drug: Upadacitinib is taken orally once daily as a tablet. It works by inhibiting enzymes called Janus kinases (JAKs), which play a role in the inflammatory process. By blocking these enzymes, upadacitinib aims to decrease inflammation and pain, potentially improving quality of life for people with this condition.
Summary
The two ongoing clinical trials for ankylosing spondylitis represent different approaches to managing this inflammatory condition. Both trials are being conducted across multiple European countries, with particularly strong representation in Bulgaria, Czechia, Poland, and Spain, where both studies are taking place.
The trials are testing two different types of medications with distinct mechanisms of action. The secukinumab trial focuses on long-term safety monitoring for patients who have already been using this biologic medication and are benefiting from it. This study is designed as an extension trial for up to 104 weeks. The upadacitinib trial, on the other hand, is evaluating a JAK inhibitor medication in a double-blind, placebo-controlled design to determine both effectiveness and safety.
Notably, these trials target slightly different patient populations. The secukinumab trial is for patients already experiencing benefits from previous treatment, while the upadacitinib trial includes patients who have had inadequate responses to or could not tolerate previous biologic treatments. This reflects the ongoing need for treatment options for patients at different stages of their disease management journey.
