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
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?

This trial tests two treatments, Secukinumab and Upadacitinib, for individuals with axial spondyloarthritis (axSpA), a type of arthritis affecting the spine and pelvis. Researchers aim to evaluate the effectiveness of each treatment after 16 weeks, assess their safety, and determine adherence levels. This trial targets those who have previously tried at least one tumor necrosis factor-alpha inhibitor without success and continue to experience active symptoms impacting daily life. Participants should not have used Secukinumab or Upadacitinib before. As a Phase 4 trial, these treatments have already received FDA approval and demonstrated effectiveness, and this research seeks to understand how they benefit more patients.

What is the safety track record for Secukinumab and Upadacitinib?

Research has shown that both secukinumab and upadacitinib are generally well-tolerated by patients with axial spondyloarthritis, a type of arthritis affecting the spine.

For secukinumab, studies indicate long-term safety, with consistent results across many trials. Patients using secukinumab for up to five years have not reported new safety issues. This treatment effectively improves symptoms and is approved for similar conditions, suggesting its safety.

Upadacitinib also shows promising safety results. Studies report it is well-tolerated, with no new safety risks found in recent trials. However, there is a warning about increased risks of serious infections and other conditions. Despite this, many patients tolerate it well, and it effectively reduces symptoms.

Extensive studies have considered both treatments safe based on available evidence.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for axial spondyloarthritis because they offer unique approaches compared to standard options like NSAIDs, TNF inhibitors, and physical therapy. Secukinumab is distinctive because it targets the IL-17 pathway, which plays a significant role in inflammation, offering a different mechanism from the commonly used TNF inhibitors. Upadacitinib, on the other hand, is a JAK inhibitor that interrupts specific enzyme pathways involved in the inflammatory process, potentially providing relief with an oral administration rather than injections. These innovative mechanisms of action could lead to more effective and convenient treatment options for patients.

What evidence suggests that this trial's treatments could be effective for axial spondyloarthritis?

This trial will compare Secukinumab and Upadacitinib for treating axial spondyloarthritis (axSpA). Research has shown that Secukinumab, which participants in this trial may receive, can help treat axSpA. In studies, patients' symptoms improved over time, with 61.5% experiencing significant improvement after six months. Another study found that Secukinumab led to a 40% improvement in symptoms at both 16 and 52 weeks.

Upadacitinib, another treatment option in this trial, is also under study for axSpA. Although specific information for this condition is limited, Upadacitinib, a JAK inhibitor, has proven effective for other inflammatory conditions. This suggests it might also benefit axSpA patients.23678

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+

Citations

5-year efficacy and safety of secukinumab in patients with ...

Secukinumab 150 mg provided sustained improvement in the signs, symptoms, and physical function in patients with ankylosing spondylitis after 5 years of ...

Improvement of Signs and Symptoms of Nonradiographic ...

Our findings indicate that secukinumab 150 mg provides significant and sustained improvement in signs and symptoms of nonradiographic axial SpA through 52 weeks ...

Efficacy and Safety of Intravenous Secukinumab in Patients ...

The primary endpoint was met as patients receiving IV secukinumab achieved a significantly greater week 16 ASAS40 response rate of 40.9% ...

Access, Effectiveness, Safety, and Survival of ...

Effectiveness of SEC after 6 months was achieved in 72/117 patients (61.5%): 44/72 patients with axial PsA (61.5%) and 28/45 patients with axSpA ...

Secukinumab, an Interleukin-17A Inhibitor, in Ankylosing ...

In a phase 2 study, intravenous secukinumab significantly suppressed the symptoms of ankylosing spondylitis. We present the results of two phase ...

Efficacy and Safety of Intravenous Secukinumab in Patients ...

IV secukinumab was effective for the treatment of adults with active axSpA over 52 weeks. The safety profile was consistent with that in previous reports on ...

Intravenous Secukinumab Demonstrates Long-Term Safety ...

Treatment with IV SEC demonstrated safety and efficacy through 52 weeks among adult patients with active axSpA.

Secukinumab Approved to Treat Nonradiographic Axial ...

The trial met its primary end point of a 40% improvement in the Assessment of Spondyloarthritis International Society domains at week 16 (41.5%) ...