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NCT Number: NCT07770646

A Pragmatic Trial of Interleukin-17 Inhibition Versus Janus Kinase Inhibition After Tumor Necrosis Factor-alpha Inhibitor Failure in Axial Spondyloarthritis

The purpose of this study is to determine the feasibility of conducting a pragmatic trial of IL-17i versus JAKi in adults with axial spondyloarthritis (axSpA) who have failed at least one tumor necrosis factor-alpha inhibitor (TNFi), to estimate the effectiveness of IL-17i versus JAKi at 16 weeks and to determine additional effectiveness measures, safety, and treatment persistence of IL-17i versus JAKi

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Key information

Conditions

Axial Spondyloarthritis (AxSpA) Ankylosis Arthritis Axial Spondyloarthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • fulfill ASAS classification criteria for axSpA and/or modified New York classification criteria for AS
  • Active axSpA (ASDAS ≥ 2.1 and/or BASDAI ≥ 4)
  • Failure of or intolerance to ≥1 TNF
  • Participants of reproductive potential must agree to use any form of effective contraception during the study period, in accordance with standard clinical practice and FDA labeling for the assigned study medication
  • Ability to provide informed consent

Exclusion criteria

  • Previously received an IL-17i or JAKi
  • Active infection requiring antimicrobials
  • Contraindications to either treatment arm:
  • Inflammatory bowel disease (IBD)- Crohn's disease or Ulcerative Colitis
  • Active cancer or cancer remission within the past 3 years (apart from non-melanoma skin cancer (NMSC) and cervical intraepithelial neoplasia (CIN)
  • History of stroke, heart attack, or blood clots (venous or arterial)
  • Cirrhosis
  • End-stage renal disease (GFR <15) or dialysis
  • Human Immunodeficiency Virus (HIV) positive
  • Pregnant or lactating
  • Concomitant use of other biologic or targeted synthetic disease-modifying anti-rheumatic drug (tsDMARD) therapy

Treatment and study plan

Secukinumab (IL-17i )

Drug

Secukinumab is a fully humananized monoclonal antibody targeting interleukin-17A. Secukinumab will be given as a prefilled syringe or autoinjector for subcutaneous administration. Dosing is 150 mg subcutaneously at weeks 0, 1, 2, 3, and 4 followed by 150mg every 4 weeks thereafter for a total of 16 weeks.

Upadacitinib (JAKi)

Drug

Upadacitinib is an oral selective inhibitor of janus kinase 1 (JAK1). Participants will take upadacitinib 15mg orally once daily for 16 weeks.

Primary outcomes

  1. Feasibility as determined by enrollment of ≥60% of eligible patients

    Time frame: end of treatment (week 16)

  2. Feasibility as determined by ≥80% retention of randomized participants

    Time frame: end of treatment (week 16)

  3. Feasibility as determined by ≥90% completeness of primary clinical data

    Time frame: end of treatment (week 16)

  4. Change in the Ankylosing Spondylitis Disease Activity Score (ASDAS) reported as a mean (SD)

    Time frame: Baseline, week 16

    This is a 4 item questionnaire and one lab result (CRP). The first 4 questions are scored from 0-10. The result is a single numerical score, typically ranging from about 0 to 6, with higher scores indicating more active disease.

Secondary outcomes

  1. Number of patients showing an improvement of ≥1.1 and ≥2.0 on the ASDAS score

    Time frame: end of treatment (week 16)

  2. Percentage of patients showing an improvement of ≥1.1 and ≥2.0 on the ASDAS score

    Time frame: end of treatment (week 16)

  3. Number of participants in the different categories of disease activity as assessed by the ASDAS

    Time frame: end of treatment (week 16)

    The ASDAS categories are:

    Inactive disease (<1.3) Low disease activity (1.3-<2.1) High disease activity (2.1-3.5) Very high disease activity (>3.5)

  4. Percentage of participants in the different categories of disease activity as assessed by the ASDAS

    Time frame: end of treatment (week 16)

    The ASDAS categories are:

    Inactive disease (<1.3) Low disease activity (1.3-<2.1) High disease activity (2.1-3.5) Very high disease activity (>3.5)

  5. Number of participants that have an ASDAS score of <2.1 and ≥2.1

    Time frame: end of treatment (week 16)

  6. Percentage of participants that have an ASDAS score of <2.1 and ≥2.1

    Time frame: end of treatment (week 16)

  7. Change in patient global disease activity measured as a mean (SD)

    Time frame: Baseline, week 16

    Disease activity is measured using a Numerical Rating Scale (NRS) from 0 (no disease) to 10 (very severe disease)

  8. Change in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) measured as a mean (SD)

    Time frame: Baseline, Week 16

    The BASDAI is a self-administered 6-question instrument covering fatigue, spinal (axial) pain, peripheral joint pain/swelling, localized tenderness (enthesitis), and the severity and duration of morning stiffness. Each question is scored 0-10. The final result is a single numerical score ranging from 0 to 10, with higher scores indicating more active disease

  9. Change in fatigue as assessed by BASDAI Q1 measured as a mean (SD)

    Time frame: Baseline, week 16

  10. Change in total back pain as assessed by BASDAI Q2 measured as a mean (SD)

    Time frame: Baseline, week 16

  11. Change in mean stiffness severity as assessed by BASDAI Q5 measured as a mean (SD)

    Time frame: Baseline, week 16

  12. Change in physical functioning as assessed by the Bath Ankylosing Spondylitis Functional Index (BASFI) measured as a mean (SD)

    Time frame: Baseline, week 16

    The Bath Ankylosing Spondylitis Functional Index (BASFI) is a self-administered 10-item questionnaire. It comprises 8 questions on function specific to axSpA and 2 questions on the patient's ability to cope with everyday life, each scored 0-10 on a visual analog scale. The final BASFI score is the mean of the 10 items, ranging from 0 (good function) to 10 (poor function), with higher scores indicating worse physical function.

  13. Number of participants who met the Assessment of SpondyloArthritis International Society 20% response (ASAS20) criteria

    Time frame: end of treatment (week 16 )

    A participant achieves an ASAS20 response if they have:

    ≥20% improvement and an absolute improvement of ≥1 unit (on a 0-10 scale) in at least 3 of the following 4 domains, with no worsening (≥20% and ≥1 unit) in the remaining domain.

    The four domains are:

    Patient global assessment Spinal pain Physical function (measured by BASFI) Inflammation (average of the two BASDAI morning stiffness questions) Higher percentages indicate a greater proportion of patients experienced clinically meaningful improvement.

  14. Percentage (%) of participants who met the ASAS20 response criteria

    Time frame: end of treatment (week 16)

    A participant achieves an ASAS20 response if they have:

    ≥20% improvement and an absolute improvement of ≥1 unit (on a 0-10 scale) in at least 3 of the following 4 domains, with no worsening (≥20% and ≥1 unit) in the remaining domain.

    The four domains are:

    Patient global assessment Spinal pain Physical function (measured by BASFI) Inflammation (average of the two BASDAI morning stiffness questions) Higher percentages indicate a greater proportion of patients experienced clinically meaningful improvement.

  15. Number of participants who met the Assessment of SpondyloArthritis International Society 40% response (ASAS40) criteria

    Time frame: end of treatment (week 16)

    A participant achieves an ASAS40 response if they have:

    ≥40% improvement and an absolute improvement of ≥2 units in at least 3 of the 4 domains, with No worsening in the remaining domain.

    Higher percentages indicate a greater proportion of patients experienced clinically meaningful improvement.

  16. Percentage of participants who met the ASAS40 response criteria

    Time frame: end of treatment (week 16)

    A participant achieves an ASAS40 response if they have:

    ≥40% improvement and an absolute improvement of ≥2 units in at least 3 of the 4 domains, with No worsening in the remaining domain.

    Higher percentages indicate a greater proportion of patients experienced clinically meaningful improvement.

  17. Change in the impact of axSpA on health and functioning as assessed by the ASAS Health Index (ASAS HI) measured as a mean (SD)

    Time frame: Baseline, week 16

    The ASAS Health Index is a self-reported 17-item questionnaire assessing functioning, disability, and overall health in spondyloarthritis. Each item is answered dichotomously and scored 1 (agree) or 0 (do not agree), producing a summed total score ranging from 0 to 17, with higher scores indicating worse health/greater impairment.

  18. Number of patients with improvement ≥3 on the ASAS HI score

    Time frame: end of treatment (week 16)

  19. Percentage of patients with improvement ≥3 on the ASAS HI score

    Time frame: end of treatment (week 16)

  20. Change in peripheral joint inflammation as assessed by the 44 Tender Joint Count (TJC44) measured as a mean(SD)

    Time frame: Baseline, week 16

    Tender Joint Count (TJC44); each of the 44 joints are scored as 0(not tender) or 1(tender) . The total score ranges from 0-44. Higher scored indicate more active peripheral arthritis.

  21. Change in peripheral joint inflammation as assessed by the 44 Swollen Joint Count (SJC44) measured as a mean(SD)

    Time frame: Baseline, week 16

    Swollen Joint Count (SJC44): each of the 44 joints are scored as 0(Not swollen) or 1(Swollen). The total score ranges from 0-44. Higher scored indicate more active peripheral arthritis.

  22. Change in peripheral joint inflammation assessed by the Disease Activity Index for Psoriatic Arthritis (DAPSA44) measured as a mean (SD)

    Time frame: Baseline, week 16

    The DAPSA44 is calculated as the simple sum of five components: the 44 Tender Joint Count (TJC44, 0-44), the 44 Swollen Joint Count (SJC44, 0-44), the patient's assessment of peripheral pain (0-10 numeric scale, using BASDAI Q3), the patient's global assessment of disease activity (0-10 numeric scale), and C-reactive protein (mg/dL). The result is a single continuous score, with higher scores indicating greater peripheral disease activity

  23. Change in severity of enthesitis as assessed by the Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) measured as a mean (SD)

    Time frame: Baseline, week 16

    The Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) is an enthesitis index, in which 13 entheseal sites are examined for tenderness and each scored as 0 (no tenderness) or 1 (tenderness present). The total score ranges from 0 to 13, with higher scores indicating greater entheseal involvement.

  24. Change in number of digits with active dactylitis as assessed by the Dactylitis Count measured as a mean(SD)

    Time frame: Baseline, week 16

    The simple dactylitis count assesses each of the 20 digits (10 fingers and 10 toes), scoring each as present (1) or absent (0) for dactylitis. The total score ranges from 0 to 20, with higher scores indicating a greater number of involved digits.

  25. Number of patients who developed psoriasis after starting treatment

    Time frame: Baseline to week 16

  26. Percentage of patients who developed psoriasis after starting treatment

    Time frame: Baseline to week 16

  27. Number of patients who had an occurrence of acute anterior uveitis (AAU) episode since starting treatment

    Time frame: Baseline to week 16

  28. Percentage of patients who had an occurrence of acute anterior uveitis (AAU) since starting treatment

    Time frame: Baseline to week 16

  29. Number of patients who developed Inflammatory Bowel Disease (IBD) during treatment

    Time frame: Baseline to week 16

  30. Percentage of patients who developed Inflammatory Bowel Disease (IBD) during treatment

    Time frame: Baseline to week 16

  31. Number of patients who had an adverse event by category during treatment

    Time frame: Baseline to week 16

    Adverse event categories include:

    • Blood and lymphatic system disorders
    • Cardiac disorders
    • Ear and labyrinth disorders
    • Endocrine disorders
    • Eye disorders
    • Gastrointestinal disorders
    • General disorders and administration site conditions
    • Hepatobiliary disorders
    • Immune system disorders
    • Infections and infestation
    • Injury, poisoning and procedural complications
    • Lab abnormalities
    • Metabolism and nutrition disorders
    • Musculoskeletal and connective tissue disorders
    • Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    • Nervous system disorders
    • Psychiatric disorders
    • Renal and urinary disorders
    • Reproductive system and breast disorders
    • Respiratory, thoracic and mediastinal disorders
    • Skin and subcutaneous tissue disorders
    • Vascular disorders

  32. Percentage of patients who had an adverse event by category during treatment

    Time frame: from baseline to week 16

    Adverse event categories include:

    • Blood and lymphatic system disorders
    • Cardiac disorders
    • Ear and labyrinth disorders
    • Endocrine disorders
    • Eye disorders
    • Gastrointestinal disorders
    • General disorders and administration site conditions
    • Hepatobiliary disorders
    • Immune system disorders
    • Infections and infestation
    • Injury, poisoning and procedural complications
    • Lab abnormalities
    • Metabolism and nutrition disorders
    • Musculoskeletal and connective tissue disorders
    • Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    • Nervous system disorders
    • Psychiatric disorders
    • Renal and urinary disorders
    • Reproductive system and breast disorders
    • Respiratory, thoracic and mediastinal disorders
    • Skin and subcutaneous tissue disorders
    • Vascular disorders

  33. Change in Erythrocyte Sedimentation Rate (ESR) measured as a mean(SD)

    Time frame: Baseline, week 16

    Higher values generally indicate greater systemic inflammation.

  34. Change in C-reactive Protein (CRP) measured as a mean(SD)

    Time frame: Baseline, week 16

    Higher values generally indicate greater inflammatory activity..

  35. Treatment persistence at week 16

    Time frame: Week 16

    Treatment persistence is defined as a patient who remains on randomzied therapy at week 16.

  36. Treatment persistence at week 52

    Time frame: End of study (week 52)

    Treatment persistence at week 52 is defined as patients who remain on randomized therapy at week 52

Study contacts

Contact information is provided by the study sponsor or research team.

Mark C Hwang, MD

CONTACT

[email protected]

(713) 500-6597

Savannah M Bowman, MD

CONTACT

[email protected]

(713) 500-6883

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

A Pragmatic Randomized Pilot Trial of Interleukin-17 Inhibition Versus Janus Kinase Inhibition After Tumor Necrosis Factor-alpha Inhibitor Failure in Axial Spondyloarthritis

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Aug 18, 2026
Registry last updated
Aug 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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