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Secukinumab vs Upadacitinib for Axial Spondyloarthritis

SM
MC
Overseen ByMark C Hwang, MD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: The University of Texas Health Science Center, Houston
Must not be taking: Other biologics, tsDMARDs
Disqualifiers: IBD, Active cancer, Stroke, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

SM

Savannah M Bowman, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for adults with axial spondyloarthritis (including ankylosing spondylitis) whose symptoms did not improve after trying at least one TNF-alpha inhibitor. Participants should meet basic health requirements set by the study.

Inclusion Criteria

Ability to provide informed consent
Fulfill ASAS classification criteria for axSpA and/or modified New York classification criteria for AS
My axial spondyloarthritis is currently active.
See 2 more

Exclusion Criteria

I have not had active cancer or been in cancer remission in the past 3 years, except for NMSC or CIN.
I am HIV positive.
Contraindications to either treatment arm: Pregnant or lactating
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either IL-17i or JAKi for 16 weeks to assess effectiveness and safety

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Extension

Participants may continue treatment to assess long-term treatment persistence

36 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Secukinumab
  • Upadacitinib

Trial Overview

The study compares two medicines: Secukinumab (an IL-17 inhibitor) and Upadacitinib (a JAK inhibitor). Patients are randomly assigned to receive one of these treatments to see which works better over 16 weeks.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Upadacitinib (JAKi)Experimental Treatment1 Intervention
Group II: Secukinumab (IL-17i )Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials
974
Recruited
361,000+

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