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Axial spondyloarthritis – Trials in Disease

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Ongoing Clinical Trials for Axial Spondyloarthritis

Currently, 15 clinical trials are investigating new treatments for axial spondyloarthritis, a chronic inflammatory condition affecting the spine and sacroiliac joints. These studies are taking place across multiple countries in Europe and are testing various approaches including biologic medications, targeted synthetic drugs, and innovative imaging techniques to better diagnose and treat this condition.

Clinical trial locations

Study Comparing Infliximab and NSAID Drug Combination for Patients with Axial Spondyloarthritis

This trial is being conducted in Germany to compare two different treatment approaches for patients who have not responded well to standard anti-inflammatory medications in outpatient care.

Who can participate: Adults aged 18 and older who have been diagnosed with axial spondyloarthritis by a rheumatologist and meet specific classification criteria. Participants must have high disease activity, shown by specific scores, and inflammation visible on MRI scans. They should have previously tried and not benefited from standard NSAID therapy. Importantly, participants must not have received certain biologic medications before joining the study.

Who cannot participate: Patients without a confirmed diagnosis, those who responded adequately to NSAID therapy, and those outside the study age range cannot join.

What the trial involves: The study compares high-dose NSAID therapy with direct treatment using a TNF blocker called infliximab. Infliximab is available as a solution for injection and a powder for infusion. NSAIDs being studied include indometacin, etoricoxib, meloxicam, celecoxib, ibuprofen lysine, naproxen sodium, and diclofenac diethylamine. The trial lasts 24 weeks, during which disease activity is regularly monitored using the Ankylosing Spondylitis Disease Activity Score and MRI scans to check for inflammation in the spine and sacroiliac joints.

Study medications: The trial tests NSAIDs, which help reduce inflammation, pain, and fever, against biosimilar TNF blockers, which target a specific protein involved in causing inflammation.

Study of 18F-AlF-FAPI-74 PET/CT imaging compared to standard 18F-FDG PET/CT in patients with fever of unknown origin, IgG4-related disease, and axial spondyloarthritis

This Belgian study evaluates whether a new imaging tracer can work as well as or better than the current standard method in detecting and evaluating inflammatory conditions.

Who can participate: Adults aged 18 and older who can provide written informed consent. For patients with spine-related conditions, they must have inflammatory back pain lasting more than 3 months that worsens at night and improves with exercise, and must have tried two different anti-inflammatory medications for 2-4 weeks without adequate relief. Women participants must be post-menopausal, surgically unable to become pregnant, or using effective birth control with a negative pregnancy test.

Who cannot participate: People under 18, pregnant or breastfeeding women, those with known allergies to study medications or contrast agents, and those unable to lie still for approximately 30 minutes during scanning.

What the trial involves: Participants receive an intravenous injection of the new imaging tracer called 18F-AlF-FAPI-74 before undergoing PET/CT scanning. This is compared to standard 18F-FDG imaging. Some participants with spine conditions may need two scans, before and after three months of treatment. The maximum tracer dose is 100 MBq per scan, with a total maximum of 550 MBq over the entire study period.

Study medications: The trial uses 18F-AlF-FAPI-74, a novel tracer targeting fibroblasts involved in inflammation, and 18F-FDG, a standard tracer that accumulates in areas of high metabolic activity.

Study of Secukinumab for Maintaining Remission in Patients with Non-Radiographic Axial Spondyloarthritis

This multinational trial, conducted across Hungary, Germany, Romania, Poland, Belgium, Czechia, Netherlands, Italy, and France, investigates whether continuous treatment with secukinumab is better than a placebo at preventing symptom flare-ups in patients who have already achieved remission.

Who can participate: Adults aged 18 and older of any gender who have been diagnosed with the condition by a rheumatologist and meet specific classification criteria. Participants must have inflammatory back pain lasting at least 6 months that started before age 45, with evidence of sacroiliitis on MRI or a positive HLA-B-27 test with SpA features. They must have active disease with specific scores and have tried at least two different NSAIDs at the highest recommended dose for at least 4 weeks without adequate relief.

Who cannot participate: Those with radiographic evidence of sacroiliitis of grade 2 or higher on both sides or grade 3 or higher on one side, those taking high potency opioid analgesics, and those previously treated with secukinumab or other IL-17 targeting biologics.

What the trial involves: Participants who achieve remission are randomly assigned to either continue receiving secukinumab or switch to a placebo in a double-blind manner. The medication is given as a 150 mg injection under the skin using a pre-filled syringe. The study monitors how many participants remain flare-free over the study period.

Study medication: Secukinumab is a biologic medication that works by blocking interleukin-17A, a protein involved in inflammation, helping to reduce pain and swelling in affected joints.

Study on Axial Spondyloarthritis Treatment Using Technetium-Labeled Certolizumab Pegol for Patients with Axial Spondyloarthritis

This Belgian study uses a special imaging technique to improve assessment of disease activity and predict treatment response.

Who can participate: Adults aged 18 to 85 with a documented diagnosis meeting specific classification criteria. Participants must meet Belgian guidelines for starting certain medications, with the decision to start therapy being a shared one between patient and rheumatologist. An MRI must have been performed within 3 months before screening, and the CRP level must be greater than 5 mg/L. Participants must have documented insufficient response to two NSAIDs at optimal doses.

Who cannot participate: Those without a confirmed diagnosis, those outside the specified age range, and vulnerable populations.

What the trial involves: Participants undergo imaging using 99mTc Certolizumab Pegol, a solution injected into a vein to help visualize inflammation. Based on imaging results and rheumatologist consultation, treatment with a biologic or targeted synthetic medication is started. Follow-up assessments occur at approximately 12 and 24 weeks, evaluating response using disease activity scores and questionnaires.

Study medication: Certolizumab Pegol is a biologic TNF inhibitor injected under the skin that blocks tumor necrosis factor-alpha, reducing inflammation and improving joint function.

Study on Fecal Microbiota Transplantation for Patients with Axial Spondyloarthritis Resistant to Conventional Treatment

This French trial explores whether fecal microbiota transplantation can help patients who have not responded well to conventional treatments.

Who can participate: Adults aged 18 to 75 with a diagnosis of the condition for at least 6 months, meeting specific criteria. They must have active symptoms with a BASDAI score of 4 or higher and back pain score of 4 or higher despite trying at least two different NSAIDs at the highest tolerated dose for at least 2 months. Participants must have tried at least one biotherapy or JAK inhibitor for at least 4 months. Current medications can be continued if doses have been stable for specified periods.

Who cannot participate: Those with other serious health conditions, pregnant or breastfeeding women, those with recent or current infections, those taking antibiotics, those with severe allergies, recent clinical trial participants, those with recent major surgery, and those with compromised immune systems.

What the trial involves: Participants receive either FMT treatment in the form of MaaT033 prolonged-release capsules or a placebo. The treatment involves transferring healthy bacteria from donor stool into the patient’s gut to restore balanced microbiota. MOVIPREP, an osmotic laxative, is used to prepare the intestines. Participants are monitored at multiple intervals over several months.

Study medication: MaaT033 contains pooled allogeneic fecal microbiota aimed at correcting imbalances in gut bacteria that may contribute to symptoms.

Study on Ixekizumab for Rapid Pain Relief in Patients with Axial Spondyloarthritis

This German trial evaluates how quickly ixekizumab can control pain by observing changes in brain activity through functional MRI scans.

Who can participate: Adults aged 18 and older who understand and sign a consent form agreeing to participate and follow study instructions. Women of childbearing potential must have a negative pregnancy test and use reliable birth control during the study and for at least 10 weeks after treatment ends. Participants must meet ASAS classification criteria with BASDAI score greater than 4 and pain score greater than 4 on a 0-10 scale. They must need biologic treatment due to active disease not responding well to two NSAIDs at highest tolerated dose. Current NSAID or pain medication doses must be stable for at least 2 weeks before and during the study.

Who cannot participate: The study excludes those who don’t meet the diagnostic and disease activity criteria specified.

What the trial involves: The medication is given through subcutaneous injection using a pre-filled pen. The study lasts 24 weeks, monitoring disease activity at various intervals. Brain activity changes are detected using fMRI to understand how the medication affects pain response. Regular assessments include MRI scans, physical examinations, and monitoring for side effects.

Study medication: Ixekizumab works by blocking certain proteins in the body that cause inflammation and pain, potentially providing relief by targeting and neutralizing interleukin-17A.

Study on Long-Term Safety of Secukinumab for Patients with Psoriatic Arthritis, Ankylosing Spondylitis, and Severe Chronic Plaque Psoriasis

This trial across Bulgaria, Czechia, Spain, Poland, Portugal, and Italy assesses the long-term safety of secukinumab in patients who have previously participated in related studies and are believed to benefit from continued treatment.

Who can participate: Participants must provide signed informed consent (with parental permission for minors). They must have completed a previous Novartis secukinumab study, be benefiting from treatment, and the investigator must believe continuing treatment will be more beneficial than risky. Participants must not have access to marketed secukinumab through local prescription or reimbursement guidelines.

Who cannot participate: Those with various conditions including psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, severe chronic plaque psoriasis, moderate to severe chronic plaque psoriasis, and juvenile idiopathic arthritis are excluded from this particular long-term safety extension.

What the trial involves: The study continues for up to 104 weeks. Participants receive secukinumab through subcutaneous injections at intervals determined by the study protocol. Healthcare professionals closely monitor for serious adverse events, adverse events, and injection site reactions throughout the study.

Study medication: Secukinumab is administered as an injection under the skin, targeting and blocking interleukin-17A to help reduce inflammation and improve symptoms.

Study on the Effects of Risankizumab in Patients with Very Early Axial Spondyloarthritis

This German study investigates risankizumab’s effects on disease activity in patients with very early signs of active disease.

Who can participate: Adults aged 18 to 40 at screening with documented diagnosis of very early disease with symptoms lasting at least 3 months but less than 2 years. Participants must have active disease defined by BASDAI score of 4 or higher and spinal pain of 4 or higher, with either elevated CRP or current MRI evidence of sacroiliitis within 3 months prior to baseline. They must be HLA-B27 positive and have shown intolerance or inadequate response to at least 2 NSAIDs. No previous treatment with biologic or targeted synthetic medications is allowed.

Who cannot participate: Those with other serious interfering health conditions, current participation in another trial, recent infection requiring antibiotics, history of allergic reactions to similar medications, pregnancy or breastfeeding, drug or alcohol abuse history, recent vaccination, history of cancer (except certain skin cancers), certain blood disorders, or weakened immune system.

What the trial involves: Participants receive either 150 mg Skyrizi (risankizumab) or placebo as subcutaneous injection using a pre-filled pen over 28 weeks. The primary assessment occurs 4 weeks after the last injection at week 32, measuring the proportion achieving low disease activity. Various assessments include MRI-related inflammatory lesions, clinical function, and disease activity scores. A follow-up phase monitors maintenance of low disease activity for at least 6 months after treatment withdrawal.

Study medication: Risankizumab inhibits interleukin-23, a protein involved in inflammation, aiming to reduce disease activity and potentially modify the disease course.

Study on the Effects of Upadacitinib for Patients with Active Psoriatic Arthritis and Axial Spondyloarthritis

This trial in Czechia, Poland, and Belgium evaluates upadacitinib’s ability to reduce symptoms such as inflammation and pain in the spine and joints of patients with active symptoms.

Who can participate: Adults aged 18 to 64 with psoriatic arthritis diagnosis by a rheumatologist, meeting specific classification criteria including evidence of psoriasis or family history. Participants must have axial involvement shown by previous imaging, active inflammation on MRI, chronic back pain for at least 3 months, and active disease with specific scores. They must have tried at least two NSAIDs for 4 weeks without adequate relief or have reasons preventing NSAID use.

Who cannot participate: Those with other arthritis types, lacking 3 months of chronic back pain, BASDAI score less than 4, back pain score less than 4, no active inflammation on MRI, or degenerative disc disease at affected areas.

What the trial involves: The 12-week study involves oral administration of 15 mg upadacitinib modified-release tablets once daily or matching placebo. Regular follow-up visits monitor health and response through physical examinations, laboratory tests, and imaging. Assessments include MRI scans and questionnaires evaluating disease activity changes at weeks 12 and 24.

Study medication: Upadacitinib is a Janus kinase inhibitor targeting specific pathways in the immune system involved in inflammation, helping to reduce pain and inflammation.

Study to measure bimekizumab concentration in breast milk of breastfeeding mothers with psoriasis, psoriatic arthritis, axial spondyloarthritis, or hidradenitis suppurativa

This study in Spain and Germany investigates how much bimekizumab passes into breast milk in mothers receiving this treatment for various chronic inflammatory conditions.

Who can participate: Women aged 18 or older currently receiving bimekizumab treatment according to approved guidelines, actively breastfeeding with plans to continue throughout the study. The decision to use bimekizumab and breastfeed must have been made before agreeing to participate. Participants must have been using bimekizumab for at least 12 weeks after delivery and must not be pregnant or planning to become pregnant during the study.

Who cannot participate: Males, those under 18 or over 55, those not currently breastfeeding, those without diagnosis of qualifying conditions, those with history of allergic reactions to similar medications, current participation in other trials, significant medical conditions interfering with the study, inability to follow procedures or attend visits, and unwillingness to provide breast milk samples.

What the trial involves: Breast milk samples are collected over two weeks, with timing dependent on dosing schedule (two-week, four-week, or eight-week intervals). Samples are taken on days 1 (before scheduled dose), 2, 3, 5, 7, 9, 11, 13, and 15, with additional samples on day 29 or 57 for longer dosing schedules. Both mothers and infants are monitored for side effects. The medication continues as prescribed by the participant’s doctor.

Study medication: Bimekizumab (Bimzelx) is a monoclonal antibody administered through subcutaneous injection that blocks IL-17A and IL-17F inflammatory proteins, available in pre-filled syringes or pens with doses of 160 mg or 320 mg.

Study on Long-Term Safety and Effectiveness of Bimekizumab for Adults with Active Axial Spondyloarthritis

This trial across Czechia, Germany, Poland, France, Hungary, Spain, and Belgium monitors the long-term safety and effectiveness of bimekizumab.

Who can participate: Participants of any gender who are considered reliable and capable of following the study protocol, completing questionnaires, attending visits, and taking medication as instructed. The study doctor must believe the participant will benefit from participation. Participants must have completed the previous AS0010 or AS0011 study, unless stopped for non-safety or non-effectiveness reasons.

Who cannot participate: Those without active disease, those outside specified age ranges, and vulnerable populations.

What the trial involves: Participants receive bimekizumab solution for injection administered subcutaneously at intervals determined by the study protocol. Regular visits monitor health and medication effects, with assessments at weeks 28, 52, and 112 evaluating response improvements, quality of life changes, and disease activity. Safety monitoring includes tracking adverse events throughout the study.

Study medication: Bimekizumab is a monoclonal antibody targeting specific proteins involved in inflammation, administered as injection under the skin to help reduce symptoms and improve quality of life.

Summary

The 15 ongoing clinical trials for axial spondyloarthritis represent a diverse range of therapeutic approaches being studied across Europe. Germany leads with the highest concentration of trials, reflecting significant research activity in this field. The studies primarily focus on biologic medications, particularly TNF blockers, IL-17 inhibitors, and newer agents like IL-23 inhibitors, as well as JAK inhibitors representing the targeted synthetic medication class.

Several trials are investigating treatment in specific patient populations, including those with very early disease and patients who have not responded to NSAIDs. Novel approaches are also being explored, such as fecal microbiota transplantation and advanced imaging techniques using specialized tracers for better disease assessment. Long-term safety studies ensure that effective treatments remain safe over extended periods.

Many trials employ sophisticated imaging techniques, particularly MRI and PET/CT scanning, to objectively measure inflammation and treatment response. The studies generally target adults aged 18 and older, with some focusing on younger adults or those with recent disease onset. Common eligibility criteria include documented diagnosis, evidence of active inflammation, and inadequate response to conventional NSAIDs.

These trials collectively aim to expand treatment options and improve outcomes for people living with axial spondyloarthritis, addressing unmet needs in both early and established disease.

Ongoing Clinical Trials on Axial spondyloarthritis

  • Study of Janus kinase inhibitor dose reduction in patients with rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis who have achieved low disease activity

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study on the Effects of Upadacitinib for Patients with Active Psoriatic Arthritis and Axial Spondyloarthritis

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Poland

  • Study of 18F-AlF-FAPI-74 PET/CT imaging compared to standard 18F-FDG PET/CT in patients with fever of unknown origin, IgG4-related disease, and axial spondyloarthritis

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium

  • Study on the Effects of Sonelokimab in Patients with Active Psoriatic Arthritis or Axial Spondyloarthritis

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study Comparing Infliximab and NSAID Drug Combination for Patients with Axial Spondyloarthritis

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study on Fecal Microbiota Transplantation for Patients with Axial Spondyloarthritis Resistant to Conventional Treatment

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study of Ixekizumab Treatment Effects on Joint and Bone Inflammation in Patients with Axial Spondyloarthritis and Psoriatic Arthritis Using Advanced Imaging Methods

    Recruiting

    1 1 1 1
    Investigated diseases:
    Denmark

  • Study on Axial Spondyloarthritis Treatment Using Technetium-Labeled Certolizumab Pegol for Patients with Axial Spondyloarthritis

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium

  • A study comparing bimekizumab and adalimumab for treating chest pain in patients with active axial spondyloarthritis who do not respond well to non-steroidal anti-inflammatory drugs.

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study to evaluate the effect of upadacitinib on the frequency of eye inflammation in patients with axial spondyloarthritis.

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria France Germany The Netherlands Poland Spain

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