Upadacitinib for Ankylosing Spondylitis

(UP-FOR-U Trial)

Overseen By Jessica Restall-Pinder

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: CARE ARTHRITIS LTD.

Must be taking: NSAIDs, bDMARDs

Must not be taking: JAK-inhibitors, TYK2-inhibitors

Disqualifiers: Active infection, Hepatitis B, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates how well the medication upadacitinib, a Janus kinase inhibitor, aids individuals with axial spondyloarthritis (axSpA) who also experience eye inflammation known as acute anterior uveitis (AAU). Researchers aim to determine if this medication can reduce the frequency of these painful eye attacks and improve overall disease symptoms, such as pain and physical function. The trial tests the drug's effects over a year, focusing on participants who have had at least one AAU episode in the past year and continue to experience active axSpA symptoms despite previous treatments. As a Phase 4 trial, this study involves an FDA-approved treatment and seeks to understand its benefits for more patients.

Do I have to stop taking my current medications for the trial?

You may need to stop certain medications before joining the trial. If you're on biologic DMARDs, there are specific times you need to wait after stopping them before starting the trial. However, you can continue taking NSAIDs, some pain relievers, and certain other medications if they are stable for a set period before the trial.

What is the safety track record for this treatment?

Research shows that upadacitinib is generally safe for people with ankylosing spondylitis. Previous studies found that taking 15 mg of upadacitinib once a day was safe for up to 104 weeks. Most participants did not experience serious side effects, though some reported mild ones.

This treatment already has FDA approval for other conditions, indicating a proven safety record. In this trial, researchers will closely monitor participants to ensure the treatment remains safe and effective for everyone involved. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Most treatments for ankylosing spondylitis, like NSAIDs and TNF inhibitors, focus on reducing inflammation and pain. But upadacitinib works differently, targeting specific enzymes called Janus kinases (JAKs) that are involved in the inflammatory process. This unique mechanism may offer more targeted relief for patients. Researchers are excited because upadacitinib has shown promise in providing effective control of symptoms with a once-daily oral dose, potentially offering a convenient alternative to existing treatments.

What is the effectiveness track record for upadacitinib in treating ankylosing spondylitis?

Research has shown that upadacitinib effectively treats ankylosing spondylitis (AS), a type of arthritis affecting the spine. One study found that it slowed the disease in patients unresponsive to other treatments over two years. Another study demonstrated that patients with axial spondyloarthritis (axSpA) experienced quick and lasting pain relief, both day and night, within 12 weeks of starting the treatment. Additionally, patients using upadacitinib reported significant improvements in their symptoms and quality of life early in the treatment. Overall, upadacitinib has provided consistent and meaningful benefits for people with AS and axSpA.

In this trial, participants will receive 15 mg of upadacitinib per day for 52 weeks to further evaluate its effectiveness and safety in treating AS. ^{6 7 8 9 10}

Who Is on the Research Team?

Walter Maksymowych, Dr.

Principal Investigator

CARE ARTHRITIS LTD.

Are You a Good Fit for This Trial?

This trial is for adults with axial spondyloarthritis who have had at least one episode of acute anterior uveitis in the past year. It's open to those who haven't responded well to biological DMARDs and those who've never taken them. Participants must be from North America or Europe.

Inclusion Criteria

I am 18 years old or older.

For all females of child-bearing potential: must not have a positive serum pregnancy test at the Screening Visit and must have a negative urine pregnancy test at Baseline prior to the first dose of study drug

My rheumatologist diagnosed me with axial spondyloarthritis.

Exclusion Criteria

I have had severe or widespread shingles or herpes.

I have had a heart problem in the past.

History of an infected joint prosthesis at any time, with the prosthesis still in situ

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 15 mg of Upadacitinib once daily to assess the impact on acute anterior uveitis over 52 weeks

52 weeks

Monthly remote visits, quarterly in-person visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Upadacitinib

Trial Overview The study tests Upadacitinib (15 mg daily) to see if it reduces the frequency of eye inflammation episodes over a year in patients with axial spondyloarthritis. The trial will also look at its effects on disease activity, pain, physical function, quality of life, and sleep.

How Is the Trial Designed?

Group I: Upadacitinib Experimental Treatment 1 Intervention

All participants enrolled in the study will receive 15 mg of Upadacitinib per day for 52 weeks.

Who Is Running the Clinical Trial?

CARE ARTHRITIS LTD.

Lead Sponsor

Trials

3

Recruited

730+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11556075/

Efficacy and safety of upadacitinib in patients with active ... Upadacitinib efficacy, including very low rates of radiographic progression, was demonstrated through 104 weeks in treatment-refractory patients with active AS.

2. rheumatologyadvisor.com rheumatologyadvisor.com/reports/upa-reduces-pain-in-axspa/

Upadacitinib Reduces Pain and Improves Outcomes in ... Patients with axSpA who received UPA reported rapid and sustained improvements in total and nocturnal back pain over 12 weeks.

3. arthritis-research.biomedcentral.com arthritis-research.biomedcentral.com/articles/10.1186/s13075-024-03441-3

Upadacitinib in active non-radiographic axial spondyloarthritis Treatment with upadacitinib demonstrated consistent improvement and maintenance of treatment effect across efficacy endpoints through 2 years; ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003496725023015

POS0894 HOW EFFECTIVE RIGHT FROM THE START A ... Treatment with UPA led to rapid and meaningful amelioration of axSpA symptom severity with improvements in parameters relevant to clinical practice demonstrated ...

5. rmdopen.bmj.com rmdopen.bmj.com/content/11/1/e005110

Efficacy of upadacitinib in subgroups of patients with axial ... At week 14, a larger proportion of patients treated with upadacitinib achieved ASAS40 compared with those who received placebo among patients ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10506267/

Efficacy and safety of upadacitinib in patients with ankylosing ... Upadacitinib 15 mg QD demonstrated sustained improvement up to 52 weeks in bDMARD-IR patients with AS. Efficacy was generally similar in patients with lack of ...

7. arthritis-research.biomedcentral.com arthritis-research.biomedcentral.com/articles/10.1186/s13075-024-03412-8

Efficacy and safety of upadacitinib in patients with active ... The long-term safety results from the bDMARD-IR AS study through week 104 showed that upadacitinib 15 mg once daily was generally well tolerated ...

8. rmdopen.bmj.com rmdopen.bmj.com/content/9/1/e002735

Safety profile of upadacitinib over 15 000 patient-years ... A definitive safety outcomes study like ORAL Surveillance has not been conducted with upadacitinib and whether the potential increased risk of ...

9. rinvoqhcp.com rinvoqhcp.com/ankylosing-spondylitis/efficacy

RINVOQ® (upadacitinib) Efficacy for Ankylosing Spondylitis Improvement in Nocturnal Back Pain · 44% improvement (n=205) vs 21% (n=202) with placebo at Week 14 as observed and 64% improvement (n=193) at 1 year as observed ...

10. acrjournals.onlinelibrary.wiley.com acrjournals.onlinelibrary.wiley.com/doi/10.1002/art.41911

Safety and Efficacy of Upadacitinib in Patients With Active ... In summary, upadacitinib 15 mg once daily showed sustained and consistent efficacy over 1 year in patients with active AS. Patients who switched ...