Active not recruitingPHASE3INTERVENTIONAL

A Study Evaluating the Effect of Filgotinib in Participants With Active Axial Spondyloarthritis

This research study is investigating a new drug called filgotinib for people who have active axial spondyloarthritis, often shortened to axSpA. We are comparing two different doses of filgotinib (200mg and 100mg daily) against a placebo, which is a dummy pill with no active drug. The main goals are to find out if filgotinib can effectively reduce the symptoms of axSpA and whether it is safe for patients to use. This kind of study helps doctors understand new treatments better, so they can provide the best care for patients living with axSpA.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Alfasigma S.p.A.

Enrolment target

495

Start

05 Apr 2023

Estimated completion

01 Dec 2028

Axial Spondyloarthritis

What is this study about?

This study is focused on a condition called axial spondyloarthritis (axSpA). This is a type of arthritis that mainly affects the spine and can cause chronic back pain and stiffness. The research is testing a new medication called filgotinib. Medications like filgotinib are designed to help reduce the inflammation that causes pain and stiffness in conditions like axSpA. By carefully comparing filgotinib with a placebo (a pill that looks the same but contains no active drug), researchers can determine if the drug effectively improves symptoms and if it's safe for people to take.

The study aims to achieve two main things. Firstly, it wants to confirm that a 200-milligram (mg) dose of filgotinib daily is effective in treating the symptoms of axSpA and doesn't cause too many side effects. Secondly, it's also comparing the 200mg dose with a lower 100mg dose. This comparison is important to see if a smaller amount of the drug can still help relieve symptoms, which might be beneficial for patients in the long run.

Understanding if a drug is effective and safe, and at what dose, is a crucial step before it can be made widely available. This study, known as a Phase 3 trial, is one of the final stages of testing. It involves a larger group of participants to gather comprehensive information about the new treatment.

Key takeaways

This study evaluates filgotinib for active axial spondyloarthritis (axSpA).
It compares two doses of filgotinib (200mg and 100mg) against a placebo.
The goal is to assess the medication's effectiveness in reducing symptoms and its safety.
Participation involves daily medication and regular clinic visits for monitoring.
You must have active axSpA and have not responded well to previous common treatments.

Who may be eligible?

To join this study, you would need to have been diagnosed with axial spondyloarthritis (axSpA) by a specialist doctor. Your axSpA must currently be active, meaning you are experiencing noticeable pain and other symptoms, even after trying common treatments.

You would also need to have tried at least two different non-steroidal anti-inflammatory drugs (NSAIDs) for at least two weeks each. This means that these standard treatments haven't quite worked for you, or you couldn't tolerate them. For some parts of the study, if you've tried other stronger medications called biologics, you might still be able to take part if those treatments also didn't work well for you.

The study is open to both men and women aged 18 years and older. Your doctor would carry out some tests, including scans and blood tests, to make sure you meet all the specific criteria for the study. This helps ensure the study includes the right people to get clear results about the new medication.

Quick self-check

I have been diagnosed with axial spondyloarthritis (axSpA) by a specialist.
My axSpA is currently active, causing ongoing pain and stiffness.
I've tried at least two different anti-inflammatory medicines (NSAIDs) for a total of four weeks or more, and they didn't work well or I couldn't tolerate them.
I am 18 years old or older.

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to receive either 200mg of filgotinib, 100mg of filgotinib, or a placebo (a dummy pill, which contains no active drug). You would take your assigned medication every day. Throughout the study, you would attend regular appointments at the clinic for check-ups. These visits would include physical examinations, blood tests, and questionnaires to track your symptoms and how you're feeling. The medical team would monitor your progress closely and check for any side effects. You would be fully supported by the study team, and they would be available to answer any questions you have.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to a new treatment before it's widely available, and close monitoring by medical professionals. This could lead to an improvement in your axSpA symptoms. However, like all medications, filgotinib may have side effects, some of which might not be fully known yet. There's also a chance you might receive the placebo, meaning you wouldn't get the active drug. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (123)

Cliniques Universitaires de Bruxelles Hopital Erasme
Brussels, Belgium
ReumaClinic
Genk, Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium
UZ Leuven
Leuven, Belgium
CHU Helora
Mons, Belgium
Medical Center Rodopimed
Kardzhali, Bulgaria
MC Medconsult Pleven
Pleven, Bulgaria
UMHAT Plovdiv AD
Plovdiv, Bulgaria
UMHAT Eurohospital Plovdiv
Plovdiv, Bulgaria
Medical Center UNIMED EOOD
Plovdiv, Bulgaria
Medical Center Teodora
Rousse, Bulgaria
Medical Center 1 Sevlievo
Sevlievo, Bulgaria

+111 more sites — see the official record for the full list.

Common questions

What is axial spondyloarthritis (axSpA)?

Axial spondyloarthritis is a type of inflammatory arthritis that mainly affects the spine and the joints where your spine meets your pelvis, causing pain and stiffness.

What is filgotinib?

Filgotinib is a new medication being tested. It works by targeting specific pathways in the body to reduce inflammation, which can help ease symptoms of axSpA.

What is a placebo?

A placebo is a 'dummy' pill that looks exactly like the study drug but contains no active medication. It helps researchers fairly compare the new drug's effects.

Will I know if I'm getting the real drug or the placebo?

No, this is a 'blinded' study, meaning neither you nor your doctor will know if you are receiving filgotinib or the placebo until the study is over. This helps ensure unbiased results.

How long will I need to be in the study?

The information provided doesn't specify the exact duration, but clinical trials usually involve several months to a couple of years of active participation with follow-up.