A Phase 4 interventional study of Secukinumab (IL-17i ) and Upadacitinib (JAKi) in Axial Spondyloarthritis (AxSpA), sponsored by The University of Texas Health Science Center, Houston. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by The University of Texas Health Science Center, Houston · Phase 4, Interventional, and Treatment
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
186 studies on the registry are indexed under Axial Spondyloarthritis; 57 are open to participants now.
This study's planned enrollment of 40 is below the median of 108 across 122 interventional studies indexed under Axial Spondyloarthritis.
Browse Axial Spondyloarthritis studies →The University of Texas Health Science Center, Houston is the lead sponsor of 897 studies on the registry; 214 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 142 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
to either treatment arm:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Secukinumab (IL-17i )
Drug: Upadacitinib (JAKi)
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 is an oral selective inhibitor of janus kinase 1 (JAK1). Participants will take upadacitinib 15mg orally once daily for 16 weeks.
Feasibility as determined by enrollment of ≥60% of eligible patients
Time frame: end of treatment (week 16)
Feasibility as determined by ≥80% retention of randomized participants
Time frame: end of treatment (week 16)
Feasibility as determined by ≥90% completeness of primary clinical data
Time frame: 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.
Time frame: Baseline, week 16
Number of patients showing an improvement of ≥1.1 and ≥2.0 on the ASDAS score
Time frame: end of treatment (week 16)
Percentage of patients showing an improvement of ≥1.1 and ≥2.0 on the ASDAS score
Time frame: 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)
Time frame: 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)
Time frame: end of treatment (week 16)
Number of participants that have an ASDAS score of <2.1 and ≥2.1
Time frame: end of treatment (week 16)
Percentage of participants that have an ASDAS score of <2.1 and ≥2.1
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, week 16
Number of patients with improvement ≥3 on the ASAS HI score
Time frame: end of treatment (week 16)
Percentage of patients with improvement ≥3 on the ASAS HI score
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Baseline, week 16
Number of patients who developed psoriasis after starting treatment
Time frame: Baseline to week 16
Percentage of patients who developed psoriasis after starting treatment
Time frame: Baseline to week 16
Number of patients who had an occurrence of acute anterior uveitis (AAU) episode since starting treatment
Time frame: Baseline to week 16
Percentage of patients who had an occurrence of acute anterior uveitis (AAU) since starting treatment
Time frame: Baseline to week 16
Number of patients who developed Inflammatory Bowel Disease (IBD) during treatment
Time frame: Baseline to week 16
Percentage of patients who developed Inflammatory Bowel Disease (IBD) during treatment
Time frame: Baseline to week 16
Number of patients who had an adverse event by category during treatment
Adverse event categories include: 1. Blood and lymphatic system disorders 2. Cardiac disorders 3. Ear and labyrinth disorders 4. Endocrine disorders 5. Eye disorders 6. Gastrointestinal disorders 7. General disorders and administration site conditions 8. Hepatobiliary disorders 9. Immune system disorders 10. Infections and infestation 11. Injury, poisoning and procedural complications 12. Lab abnormalities 13. Metabolism and nutrition disorders 14. Musculoskeletal and connective tissue disorders 15. Neoplasms benign, malignant and unspecified (incl cysts and polyps) 16. Nervous system disorders 17. Psychiatric disorders 18. Renal and urinary disorders 19. Reproductive system and breast disorders 20. Respiratory, thoracic and mediastinal disorders 21. Skin and subcutaneous tissue disorders 22. Vascular disorders
Time frame: Baseline to week 16
Percentage of patients who had an adverse event by category during treatment
Adverse event categories include: 1. Blood and lymphatic system disorders 2. Cardiac disorders 3. Ear and labyrinth disorders 4. Endocrine disorders 5. Eye disorders 6. Gastrointestinal disorders 7. General disorders and administration site conditions 8. Hepatobiliary disorders 9. Immune system disorders 10. Infections and infestation 11. Injury, poisoning and procedural complications 12. Lab abnormalities 13. Metabolism and nutrition disorders 14. Musculoskeletal and connective tissue disorders 15. Neoplasms benign, malignant and unspecified (incl cysts and polyps) 16. Nervous system disorders 17. Psychiatric disorders 18. Renal and urinary disorders 19. Reproductive system and breast disorders 20. Respiratory, thoracic and mediastinal disorders 21. Skin and subcutaneous tissue disorders 22. Vascular disorders
Time frame: from baseline to week 16
Change in Erythrocyte Sedimentation Rate (ESR) measured as a mean(SD)
Higher values generally indicate greater systemic inflammation.
Time frame: Baseline, week 16
Change in C-reactive Protein (CRP) measured as a mean(SD)
Higher values generally indicate greater inflammatory activity..
Time frame: Baseline, week 16
Treatment persistence at week 16
Treatment persistence is defined as a patient who remains on randomized therapy at week 16.
Time frame: Week 16
Treatment persistence at week 52
Treatment persistence at week 52 is defined as patients who remain on randomized therapy at week 52
Time frame: End of study (week 52)
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drugs tested here: Secukinumab · Upadacitinib
The University of Texas Health Science Center, Houston →