A Pragmatic Trial of Interleukin-17 Inhibition Versus Janus Kinase Inhibition After Tumor Necrosis Factor-alpha Inhibitor Failure in Axial Spondyloarthritis
Part of paid clinical trials in Houston, Texas.
- Sponsor
- The University of Texas Health Science Center, Houston
- Study ID
- NCT07770646
- Phase
- PHASE4
- Status
- Not Yet Recruiting
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Conditions
- Axial Spondyloarthritis (AxSpA)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Secukinumab (IL-17i ) — DRUGSecukinumab 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) — DRUGUpadacitinib is an oral selective inhibitor of janus kinase 1 (JAK1). Participants will take upadacitinib 15mg orally once daily for 16 weeks.
Study Details
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
Key Dates
- First listed
- Aug 18, 2026
- Start date
- Sep 14, 2026
- Status verified
- Aug 2026
- Primary completion
- Sep 15, 2028
- Completion
- Sep 15, 2029
Study Design
- Enrollment
- 40 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Secukinumab (IL-17i )
- Experimental: Upadacitinib (JAKi)
Primary Outcome Measure
Feasibility as determined by enrollment of ≥60% of eligible patients [ Time Frame: end of treatment (week 16) ]
Central Contacts
- Savannah M Bowman, MD(713) 500-6883
- Mark C Hwang, MD(713) 500-6597
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| The University of Texas health Science Center at Houston | Houston | Texas | 77030 |