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Home › Conditions › Ankylosing Spondylitis

Ankylosing Spondylitis

Part of Arthritis

9 published articles · Updated continuously

Clinical Trial Landscape

Clinical Trials for Ankylosing Spondylitis

79 trials tracked for Ankylosing Spondylitis: 33 in phase 3 or 4 and 12 with published results. The most-cited published study has 142 citations.

79Trials tracked
33Phase 3 & 4
0Recruiting
12With published results
Phase distribution
Phase 4 10 Phase 3 23 Phase 2 10 Phase 1 3 Other / NA 33
  1. Phase 3 Extension in AS: Sustainability of Benefits, Safety and Tolerability Completed · 142 cited
  2. Phase 3 A Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing Spondylitis Completed · 106 cited
  3. Phase 3 Study to Evaluate Maintenance of Sustained Remission of axSpA With CZP Compared to Placebo Completed · 71 cited
  4. Phase 3 A Study of Golimumab in Participants With Active Ankylosing Spondylitis Completed · 69 cited
  5. Phase 3 16-week Efficacy and 3-year Safety, Tolerability and Efficacy of Secukinumab in Active Ankylosing Spondylitis Patients Completed · 60 cited
  6. Phase 3 Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as Compared to GP2017 (Adalimumab Biosimilar) Completed · 51 cited
Show 44 more trials
  1. Phase 3 16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Ankylosing Spondylitis Completed · 38 cited
  2. Phase 3 16 Week Efficacy and 2 Year Long Term Safety and Efficacy of Secukinumab in Patients With Active Ankylosing Spondylitis Completed · 22 cited
  3. Phase 4 Etanercept Withdrawal And Retreament Study In Subjects With Nr-ax SpA Completed · 6 cited
  4. Phase 3 Efficacy and Safety of Tofacitinib in Subjects With Active Ankylosing Spondylitis (AS) Completed · 6 cited
  5. Phase 4 Study Estimating the Clinical Difference Between 300 mg and 150 mg of Secukinumab Following Dose Escalation to 300 mg in Patients With Ankylosing Spondylitis Completed · 3 cited
  6. Phase 4 Study to Examine the Clinical Efficacy and the Nonsteroidal Anti-inflammatory Drug (NSAID)-Sparing Effect of Secukinumab Over 16 Weeks in Patients With Ankylosing Spondylitis Completed · 1 cited
  7. Phase 4 The Incidence of Extra-Articular Manifestations in Participants With Ankylosing Spondylitis Treated With Golimumab (MK-8259-012) Completed
  8. Phase 4 A Study of Golimumab in the Treatment of Indian Participants With Active Spondyloarthropathy of Ankylosing Spondylitis or Psoriatic Arthritis Completed
  9. Phase 4 Study Evaluating Etanercept in Subjects With Ankylosing Spondylitis in Spain Completed
  10. Phase 4 Extension Study Evaluating Etanercept in Ankylosing Spondylitis Completed
  11. Phase 4 Study Evaluating Etanercept for the Treatment of Active, Severe, and Advanced Axial Ankylosing Spondylitis Completed
  12. Phase 4 Study Evaluating Etanercept and Sulphasalazine in Ankylosing Spondylitis Completed
  13. Phase 4 Analysis of the Peripheral Blood Mononuclear Cells of Patients With Ankylosing Spondylitis During Infliximab Treatment (Study P04465)(COMPLETED) Completed
  14. Phase 3 Study of Efficacy and Safety of Secukinumab in Japanese Patients With Active Ankylosing Spondylitis Completed
  15. Phase 3 Study to Demonstrate the Efficacy, Safety and Tolerability of an Intravenous Regimen of Secukinumab Compared to Placebo in Subjects With Active axSpA Completed
  16. Phase 3 Efficacy and Safety of Adalimumab in Adult Chinese Subjects With Active Ankylosing Spondylitis Completed
  17. Phase 3 Study of the Safety and Efficacy of Golimumab in Chinese Patients With Ankylosing Spondylitis Completed
  18. Phase 3 A Study of the Safety and Efficacy of Golimumab in Subjects With Active Ankylosing Spondylitis Completed
  19. Phase 3 Effect of Golimumab in Participants With Active Axial Spondyloarthritis (P07642, MK-8259-006) Completed
  20. Phase 3 A Two-Part 26-Week Study of Etoricoxib as Treatment for Ankylosing Spondylitis (AS) (MK-0663-108) Completed
  21. Phase 3 Study Comparing Etanercept (ETN) Against a Placebo for Etanercept on a Background Nonsteroidal Anti Inflammatory Drug (NSAIDs) in the Treatment of Early Spondyloarthritis (SpA) Patients Who do Not Have X-ray Structural Changes Completed
  22. Phase 3 A Study of Adalimumab in Japanese Subjects With Active Ankylosing Spondylitis Completed
  23. Phase 3 Human Anti-tumor Necrosis Factor (TNF) Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing Spondylitis Completed
  24. Phase 3 Study Of Celecoxib Or Diclofenac For Efficacy and Safety In Chinese Patients With Ankylosing Spondylitis Completed
  25. Phase 3 Assessment of the Response to Etoricoxib in Patients With Ankylosing Spondylitis and Inadequate Response to ≥2 NSAIDs Completed
  26. Phase 3 Safety and Efficacy of Adalimumab in Patients With Active Ankylosing Spondylitis Completed
  27. Phase 3 Infliximab for Treatment of Axial Spondyloarthritis (P05336 AM1) Completed
  28. Phase 2 Dose-Ranging Study Of Tofacitinib In Adults With Active Ankylosing Spondylitis Completed
  29. Phase 2 Double Blind, Placebo Controlled Study to Assess Efficacy of AIN457 in Moderate to Severe Ankylosing Spondylitis Completed
  30. Phase 2 Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis Completed
  31. Phase 2 A Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing Spondylitis Completed
  32. Phase 2 A Study to Test the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Patients With Active Ankylosing Spondylitis Completed
  33. Phase 2 Spondylitis Trial of Apremilast for Better Rheumatic Therapy Completed
  34. Phase 2 Safety and Effectiveness of Live Zoster Vaccine in Anti-Tumor Necrosis Factor (TNF) Users (VERVE Trial) Completed
  35. Phase 2 Safety and Tolerability of AIN457 in Adults (18-65 Years) With Moderate to Severe Ankylosing Spondylitis Completed
  36. Phase 2 Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males With Active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, or Non-radiographic Axial Spondyloarthritis Completed
  37. Phase 2 A Study to Evaluate the Efficacy and Safety of Different Doses of Bimekizumab in Subjects With Active Ankylosing Spondylitis Completed
  38. Phase 1 Comparative Evaluation of Pharmacokinetics and Safety of BCD-055 and Remicade in Patients With Ankylosing Spondylitis Completed
  39. Phase 1 A Multicener, Postmarketing Study Evaluating the Transfer of Cimzia From the Mother to the Infant Via the Placenta Completed
  40. Phase 1 A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers Completed
  41. N/A Clinical and Radiological Manifestations of Coxitis in Patients With Ankylosing Spondylitis Treated With Golimumab Completed
  42. N/A T Cells and TNF (Tumor Necrosis Factor): The Impact of TNF Blockade Completed
  43. N/A Remicade Safety Line (Ankylosing Spondylitis)(Study P03275)(COMPLETED) Completed
  44. N/A National Observational Study On The Use Of Inflectra™ An Infliximab Biosimilar In Real Life Completed

Showing the 50 most-cited and recently-updated of 79 trials. Browse the full registry →

Trial data sourced from ClinicalTrials.gov. Counts describe the research landscape and are not a treatment recommendation. Informational only — not medical advice.

What the trials found For clinicians

Ankylosing Spondylitis: what the trials found

Several biologic therapies have demonstrated efficacy in improving clinical outcomes in ankylosing spondylitis (AS). Etanercept significantly increased ASAS20 response rates compared to placebo (p<0.001) 6, though some studies showed no significant difference in ASAS20 (p=0.6031) 10 or BASDAI50 (p=0.098) 8. Golimumab reduced the annual incidence of uveitis attacks (p<0.0001) 5 and achieved ASAS20 in 74.5% at week 14 4. Secukinumab showed significant improvements in ASAS20 (p<0.0001) 18 and ASAS40 (p<0.0001) 20 compared to placebo, with similar results for bimekizumab (ASAS40 p<0.001) 12 and tofacitinib (ASAS20 p<0.0001) 19. Certolizumab pegol reduced flare rates (p<0.001) 13. However, some trials reported non-significant p-values for certain outcomes, such as ASAS20 for secukinumab (p=0.3512) 3 and healthcare resource use for etanercept (p=0.743) 7.

Quality of life and disease activity measures also improved with treatment. Etanercept showed changes in ASQoL but not significantly (p=0.719) 6. Secukinumab improved SF-36 PCS and ASQoL scores 21. Tofacitinib significantly reduced BASDAI (p<0.0001) 19. Radiographic progression over 104 weeks showed no significant difference between treatment groups (p=0.7164) 17. Golimumab reduced uveitis attacks (p<0.0001) 5. Overall, while many biologics show benefit, some outcomes have conflicting or non-significant results, indicating variability in response.

Recent results — preliminary, needs further review

  • Bimekizumab, a newer biologic, demonstrated significant ASAS40 response at week 16 (44.8% vs 22.5%, p<0.001) in a phase 3 trial 12.
  • Tofacitinib, a JAK inhibitor, showed significant ASAS20 and ASAS40 responses at week 16 (p<0.0001) in a phase 3 trial 19.
  • Certolizumab pegol significantly reduced flare rates (p<0.001) and achieved sustained remission in 43.9% at week 48 13.
  • Secukinumab in a phase 3 trial showed significant ASAS40 response (40.85% vs 22.94%, p<0.0001) and ASDAS major improvement (p<0.0001) 20.
  • No significant difference in radiographic progression was observed over 104 weeks with secukinumab vs placebo (p=0.7164) 17.

For the clinician treating this condition

  • Etanercept, secukinumab, bimekizumab, tofacitinib, and certolizumab pegol have shown significant improvements in ASAS response rates compared to placebo.
  • Golimumab reduced uveitis attacks and improved ASAS20 response in AS patients.
  • Radiographic progression over 2 years was not significantly different between secukinumab and placebo, suggesting limited impact on structural damage.

AI synthesis of 14 cited trials, updated Jun 24, 2026. Informational only — not medical advice; trial data sourced from ClinicalTrials.gov. How we use AI.

HCP Mode — summaries include clinical detail, trial data, and statistical outcomes.
Patient Mode — summaries use plain language, avoiding clinical jargon.
Adalimumab and its biosimilar IBI303 show distinct response clusters in ankylosing spondylitis
Allergy & Immunology RCT
Adalimumab and its biosimilar IBI303 show distinct response clusters in ankylosing spondylitis Trial shows two different ways patients respond to adalimumab
This Phase III randomized controlled trial of 438 patients with active ankylosing spondylitis identified two longitudinal response clusters.…
A new study identifies two distinct groups of people with ankylosing spondylitis who react differently to the same treatment.
Frontiers Jul 5, 2026
Axial psoriatic arthritis is associated with significantly lower HLA-B27 positivity than axial spondyloarthritis
Gastroenterology Meta-analysis
Axial psoriatic arthritis is associated with significantly lower HLA-B27 positivity than axial spondyloarthritis Genetic Markers Help Distinguish Psoriatic Arthritis From Spondylitis
This meta-analysis compared clinical features between patients with axial psoriatic arthritis (ax-PsA) and axial spondyloarthritis (ax-SpA).…
A large review of over 10,000 patients shows that specific genetic markers can help doctors tell two similar types of arthritis apart.
Frontiers Jun 23, 2026
Large meta-analysis identifies 30 new genetic loci for ankylosing spondylitis risk
Gastroenterology Meta-analysis
Large meta-analysis identifies 30 new genetic loci for ankylosing spondylitis risk Scientists found genetic links to ankylosing spondylitis in large health data groups
This meta-analysis of 7,551 AS cases and 1,258,581 controls from three biobanks identified 30 genome-wide significant loci and 64 causal-can…
A big study looked at DNA from many people to find genes linked to ankylosing spondylitis. It found specific spots in our genes that might h…
Frontiers Jun 2, 2026
Vunakizumab improves ASAS20 response in active radiographic axial spondyloarthritis at 16 weeks
Rheumatology RCT
Vunakizumab improves ASAS20 response in active radiographic axial spondyloarthritis at 16 weeks New Drug Offers Hope for Ankylosing Spondylitis Patients
This randomized, double-blind, placebo-controlled phase 2 to 3 trial included 548 adults with active r-axSpA in China. At week 16, the vunak…
If you live with the daily stiffness and pain of ankylosing spondylitis, a new treatment option may be on the horizon that works better than…
May 8, 2026
FDA Approves Hadlima (adalimumab) for Multiple Inflammatory Indications
Rheumatology FDA Approval
FDA Approves Hadlima (adalimumab) for Multiple Inflammatory Indications FDA approves Hadlima, a new biosimilar for several inflammatory diseases.
The FDA approved Hadlima (adalimumab) for several inflammatory conditions including rheumatoid arthritis, juvenile idiopathic arthritis, pso…
The FDA approved Hadlima (adalimumab) for treating conditions like rheumatoid arthritis, psoriasis, and Crohn's disease. It is a biosimilar,…
FDA May 5, 2026
Systematic review explores the role of RNA methylation in autoimmune rheumatic diseases
Rheumatology Sys. Review
Systematic review explores the role of RNA methylation in autoimmune rheumatic diseases RNA Methylation Could Change How We Treat Joint Pain
This systematic review examines the impact of RNA methylation on various autoimmune rheumatic diseases, including rheumatoid arthritis and s…
A new review explains how tiny chemical tags on RNA control inflammation and could lead to better treatments for painful autoimmune diseases…
Frontiers May 2, 2026
Biosimilar switching maintains disease control in stable ankylosing spondylitis patients
Drug Pipeline RCT
Biosimilar switching maintains disease control in stable ankylosing spondylitis patients Cheaper Arthritis Drugs Work Just as Well
This structured narrative review of patients with stable ankylosing spondylitis found that switching from reference biologics to biosimilars…
Switching to cheaper arthritis drugs keeps patients just as healthy while cutting treatment costs in half without losing results.
Frontiers Apr 19, 2026
Sudden sensorineural hearing loss risk factors in ankylosing spondylitis patients on adalimumab plus methotrexate
Neurology Cohort
Sudden sensorineural hearing loss risk factors in ankylosing spondylitis patients on adalimumab plus methotrexate Could long-term arthritis treatment raise your risk of sudden hearing loss?
This retrospective case-control analysis drew on 2,564 ankylosing spondylitis patients at Henan Provincial People's Hospital (2015-2024), co…
Patients with long-term ankylosing spondylitis taking adalimumab and methotrexate are more likely to experience sudden hearing loss than tho…
Frontiers Apr 16, 2026
Phase III trial of AK111 for active ankylosing spondylitis completed with 510 patients
Rheumatology Phase III
Phase III trial of AK111 for active ankylosing spondylitis completed with 510 patients Can a new drug help people with painful spinal arthritis move more freely?
A Phase III, randomized, double-blind, placebo-controlled, multicenter study evaluated AK111 in 510 patients with active ankylosing spondyli…
A new drug called AK111 aims to help people with painful spinal arthritis move more freely by improving symptoms like pain and stiffness.
CT.gov Mar 30, 2026

Questions about Ankylosing Spondylitis

Does switching to a biosimilar maintain disease control in stable ankylosing spondylitis?

Yes, switching to a biosimilar maintains disease control in stable ankylosing spondylitis, with comparable efficacy and safety based on randomized trials and real-world data.

Full answer →
Is Hadlima approved by the FDA for treating ankylosing spondylitis?

Yes, the FDA has approved Hadlima (adalimumab) for treating active ankylosing spondylitis in adults.

Full answer →