What this study is
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
What's being tested
- Secukinumab (IL-17i )
Intervention · 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)
Intervention · DRUG
Upadacitinib is an oral selective inhibitor of janus kinase 1 (JAK1). Participants will take upadacitinib 15mg orally once daily for 16 weeks.
Study details
- 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
- Sponsor
- The University of Texas Health Science Center, Houston
- Conditions
- Axial Spondyloarthritis (AxSpA)
- Enrolling
- 40 people
- Starts
- 2026-11-01
- Est. completion
- 2029-09-15
- Design
- Single-blind, randomized, parallel groups, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openThe University of Texas health Science Center at Houston
Houston, Texas, United States
- Savannah Bowman, MD · Contact(713) 500-6883Savannah.Bowman@uth.tmc.edu
- Mark C Hwang · Contact(713) 500-6597Mark.C.Hwang@uth.tmc.edu
Study team
Sponsor
The University of Texas Health Science Center, Houston
Study ID HSC-MS-26-0457
Principal investigator
Savannah M Bowman, MD
The University of Texas Health Science Center, Houston
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.