Axial Spondyloarthritis (AxSpA)Phase 4NCT07770646
A Pragmatic Trial of Interleukin-17 Inhibition Versus Janus Kinase Inhibition After Tumor Necrosis Factor-alpha Inhibitor Failure in Axial Spondyloarthritis
A Phase 4 study testing Secukinumab (IL-17i ) and Upadacitinib (JAKi) in people with Axial Spondyloarthritis (AxSpA), run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Axial Spondyloarthritis (AxSpA)
- What is being tested?
- Secukinumab (IL-17i ) and Upadacitinib (JAKi)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 15 Sep 2029
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The University of Texas health Science Center at Houston
Houston, Texas, 77030
Savannah Bowman, MD, (713) 500-6883, Savannah.Bowman@uth.tmc.edu
Mark C Hwang, (713) 500-6597, Mark.C.Hwang@uth.tmc.edu
About this study
Official title: A Pragmatic Randomized Pilot 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
- Conditions
- Axial Spondyloarthritis (AxSpA)
- Being tested
- Secukinumab (IL-17i ), Upadacitinib (JAKi)
- Keywords
- comparative effectiveness, axial spondyloarthritis, secukinumab, upadacitinib
- Medical subject headings
- Axial Spondyloarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Secukinumab (IL-17i )Drug
Secukinumab is a fully humanized 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.
| Study group | Role | What they receive |
|---|---|---|
| Secukinumab (IL-17i ) | Experimental | Not described Receives: Drug: Secukinumab (IL-17i ) |
| Upadacitinib (JAKi) | Experimental | Not described Receives: Drug: Upadacitinib (JAKi) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as determined by enrollment of ≥60% of eligible patients
Measured: end of treatment (week 16)
Feasibility as determined by ≥80% retention of randomized participants
Measured: end of treatment (week 16)
Feasibility as determined by ≥90% completeness of primary clinical data
Measured: end of treatment (week 16)
Change in the Ankylosing Spondylitis Disease Activity Score (ASDAS) reported as a mean (SD)
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.
Measured: Baseline, week 16
Secondary outcomes (36)
Number of patients showing an improvement of ≥1.1 and ≥2.0 on the ASDAS score
Measured: end of treatment (week 16)
Percentage of patients showing an improvement of ≥1.1 and ≥2.0 on the ASDAS score
Measured: end of treatment (week 16)
Number of participants in the different categories of disease activity as assessed by the ASDAS
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)
Measured: end of treatment (week 16)
Percentage of participants in the different categories of disease activity as assessed by the ASDAS
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)
Measured: end of treatment (week 16)
Number of participants that have an ASDAS score of <2.1 and ≥2.1
Measured: end of treatment (week 16)
Percentage of participants that have an ASDAS score of <2.1 and ≥2.1
Measured: end of treatment (week 16)
Change in patient global disease activity measured as a mean (SD)
Disease activity is measured using a Numerical Rating Scale (NRS) from 0 (no disease) to 10 (very severe disease)
Measured: Baseline, week 16
Change in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) measured as a mean (SD)
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
Measured: Baseline, Week 16
Change in fatigue as assessed by BASDAI Q1 measured as a mean (SD)
Fatigue will be assessed using Question 1of the BASDAI and this will be scored on a 0-10 numerical rating scale, where 0 = none and 10 = very severe. The outcome will be reported as the mean (SD). A negative change indicates improvement (reduction in fatigue), while a positive change indicates worsening fatigue
Measured: Baseline, week 16
Change in total back pain as assessed by BASDAI Q2 measured as a mean (SD)
Total back pain will be assessed using Question 2 of the BASDAI and this will be scored on a 0-10 numerical rating scale, where 0 = none and 10 = very severe. The outcome will be reported as the mean (SD). A negative change indicates improvement (reduction in pain), while a positive change indicates worsening pain
Measured: Baseline, week 16
Change in mean stiffness severity as assessed by BASDAI Q5 measured as a mean (SD)
Stiffness severity will be assessed using Question 5 of the BASDAI and this will be scored on a 0-10 numerical rating scale, where 0 = no stiffness and 10 = most severe stiffness. The outcome will be reported as the mean (SD). A negative change indicates improvement (reduction in stiffness)while a positive change indicates worsening stiffness
Measured: Baseline, week 16
Change in physical functioning as assessed by the Bath Ankylosing Spondylitis Functional Index (BASFI) measured as a mean (SD)
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.
Measured: Baseline, week 16
Number of participants who met the Assessment of SpondyloArthritis International Society 20% response (ASAS20) criteria
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.
Measured: end of treatment (week 16 )
Percentage (%) of participants who met the ASAS20 response criteria
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.
Measured: end of treatment (week 16)
Number of participants who met the Assessment of SpondyloArthritis International Society 40% response (ASAS40) criteria
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.
Measured: end of treatment (week 16)
Percentage of participants who met the ASAS40 response criteria
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.
Measured: end of treatment (week 16)
Change in the impact of axSpA on health and functioning as assessed by the ASAS Health Index (ASAS HI) measured as a mean (SD)
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.
Measured: Baseline, week 16
Number of patients with improvement ≥3 on the ASAS HI score
Measured: end of treatment (week 16)
Percentage of patients with improvement ≥3 on the ASAS HI score
Measured: end of treatment (week 16)
Change in peripheral joint inflammation as assessed by the 44 Tender Joint Count (TJC44) measured as a mean(SD)
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.
Measured: Baseline, week 16
Change in peripheral joint inflammation as assessed by the 44 Swollen Joint Count (SJC44) measured as a mean(SD)
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.
Measured: Baseline, week 16
Change in peripheral joint inflammation assessed by the Disease Activity Index for Psoriatic Arthritis (DAPSA44) measured as a mean (SD)
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
Measured: Baseline, week 16
Change in severity of enthesitis as assessed by the Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) measured as a mean (SD)
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.
Measured: Baseline, week 16
Change in number of digits with active dactylitis as assessed by the Dactylitis Count measured as a mean(SD)
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.
Measured: Baseline, week 16
Number of patients who developed psoriasis after starting treatment
Measured: Baseline to week 16
Percentage of patients who developed psoriasis after starting treatment
Measured: Baseline to week 16
Number of patients who had an occurrence of acute anterior uveitis (AAU) episode since starting treatment
Measured: Baseline to week 16
Percentage of patients who had an occurrence of acute anterior uveitis (AAU) since starting treatment
Measured: Baseline to week 16
Number of patients who developed Inflammatory Bowel Disease (IBD) during treatment
Measured: Baseline to week 16
Percentage of patients who developed Inflammatory Bowel Disease (IBD) during treatment
Measured: Baseline to week 16
Number of patients who had an adverse event by category during treatment
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
Measured: Baseline to week 16
Percentage of patients who had an adverse event by category during treatment
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
Measured: from baseline to week 16
Change in Erythrocyte Sedimentation Rate (ESR) measured as a mean(SD)
Higher values generally indicate greater systemic inflammation.
Measured: Baseline, week 16
Change in C-reactive Protein (CRP) measured as a mean(SD)
Higher values generally indicate greater inflammatory activity..
Measured: Baseline, week 16
Treatment persistence at week 16
Treatment persistence is defined as a patient who remains on randomized therapy at week 16.
Measured: Week 16
Treatment persistence at week 52
Treatment persistence at week 52 is defined as patients who remain on randomized therapy at week 52
Measured: End of study (week 52)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start1 Nov 2026 (estimated)
- Primary completion15 Sep 2028 (estimated)
- Study completion15 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Axial Spondyloarthritis (AxSpA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Savannah Bowman, The University of Texas Health Science Center, Houston
- Investigators
- Savannah M Bowman, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07770646
- Sponsor's protocol ID
- HSC-MS-26-0457
- Status last verified
- Oct 2026
- First submitted
- 12 Aug 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No