Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase 3 Randomized, Placebo-Controlled, Double-Blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult Subjects with Axial Spondyloarthritis Followed by a Remission-Withdrawal Period

This research is looking at a new medication called Upadacitinib for adults who have a form of arthritis known as axial spondyloarthritis. This condition mainly causes long-term pain and stiffness in the back and spine. The study is divided into two parts, where some participants will receive the active medication and others will receive a placebo (a dummy pill with no active drug). Researchers want to find out how well Upadacitinib works to reduce symptoms like pain and stiffness, and they also want to check for any side effects. After a period of taking the medication, there will be a phase where the treatment might be stopped to see how participants respond. The overall goal is to understand if this new medicine could be a safe and effective option for people living with axial spondyloarthritis.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Abbvie Deutschland GmbH & Co. KG

Enrolment target

272

Start

06 Dec 2022

Axial Spondyloarthritis

What is this study about?

This study is investigating a new medicine called Upadacitinib for adults who have a condition known as axial spondyloarthritis. This is a long-term type of arthritis that mainly affects the spine and the joints where the spine meets the pelvis. It can cause ongoing pain, stiffness, and sometimes limit movement. While there are treatments available, researchers are always looking for new and better ways to help people manage their symptoms and improve their quality of life.

This particular study is a 'Phase 3' trial, which means the medicine has already gone through earlier testing and shown promise. In this phase, a larger group of people will take part to confirm if the medicine is effective and safe over a longer period. Participants will be randomly assigned to receive either Upadacitinib or a placebo, which looks identical to the real medicine but contains no active drug. This 'double-blind' approach means neither you nor your study doctor will know which you are receiving, which ensures the results are as fair and unbiased as possible.

The main aim of the study is to see if Upadacitinib can significantly reduce the symptoms of axial spondyloarthritis, such as back pain and stiffness, after 14 weeks compared to the placebo. Researchers will also be looking at many other effects, like changes in daily function, overall well-being, and signs of inflammation in the body. There's also a special part of the study where, if symptoms improve, the treatment might be stopped temporarily to see how the body responds. Taking part in a study like this helps us understand more about new treatments and contributes to finding better ways to help people living with this condition.

Key takeaways

The study is testing a new medicine, Upadacitinib, for adults with axial spondyloarthritis.
It compares the medicine to a dummy pill to see if it helps with pain and stiffness.
You won't know if you're getting the active medicine or the dummy pill (placebo).
Participation involves regular clinic visits, physical checks, and questionnaires.
The study aims to confirm if Upadacitinib is safe and effective.
You can stop participating at any time if you wish.

Who may be eligible?

This study is looking for adults aged 18 years and older who have been diagnosed with axial spondyloarthritis. Both men and women are welcome to participate.

To be eligible, you will need to meet specific health requirements related to your condition and overall health. For example, your doctor will check if your axial spondyloarthritis is active enough for the study to determine if the medicine is helping. There will also be other health checks to make sure the study medicine would be safe for you.

It's important to discuss your full medical history with the study team, as certain other health conditions or medications might prevent you from taking part. They will carefully review everything to ensure the study is safe and appropriate for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with axial spondyloarthritis?
Is your axial spondyloarthritis currently active?
Are you able to attend regular clinic appointments for the study?
Are you open to the possibility of receiving either the study medicine or a placebo?
Are you able to understand and agree to the participation requirements?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would first have a screening visit to check if you meet all the requirements. If eligible, you would be randomly assigned to either receive the study medicine (Upadacitinib) or a placebo (a dummy pill). Neither you nor your study doctor would know which one you are receiving.

You would take your assigned treatment every day. Over the course of the study, you would attend regular visits to the clinic. These visits would involve various assessments, such as physical examinations, answering questionnaires about your pain and daily activities, and providing blood samples. You might also have scans, like MRI scans, to check for any changes in your spine.

The study would have different phases, including a period where you take the medicine, and potentially a 'remission-withdrawal' period where treatment might be stopped if your symptoms improve significantly, to see how your body reacts. The total duration of your participation would be explained in full by the study team, but typically, these types of studies involve several months of regular visits and follow-up.

Potential risks and benefits

Taking part in a clinical trial offers the chance to access a new potential treatment before it's widely available. The study medicine, Upadacitinib, may help reduce your symptoms like pain and stiffness. It's also an opportunity to contribute valuable information that could help others with axial spondyloarthritis in the future. However, there are potential risks, as with any medication. The study medicine might cause side effects, some of which could be unexpected or serious. The study team will closely monitor your health throughout. It's important to remember that you can stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (9)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Germany
—
Unverified
France
—
Unverified
Bulgaria
—
Unverified
Hungary
—
Unverified
Poland
—
Unverified
Spain
—
Unverified
Slovakia
—
Unverified
Czechia
—
Unverified
Belgium

Common questions

What is axial spondyloarthritis?

It's a form of arthritis that mostly causes long-term pain and stiffness in your back, neck, and sometimes other joints.

What is Upadacitinib?

It's an experimental medicine being tested to see if it can help people with axial spondyloarthritis.

What's a 'placebo'?

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

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

No, neither you nor your study doctor will know. This is called 'double-blind' and makes the results more reliable.

What happens if my symptoms get better or worse?

The study team will closely monitor your health. If your symptoms improve significantly, there might be a period where treatment is paused. If your symptoms worsen or you have concerns, the study team will provide guidance and care.