Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of Tildrakizumab in Anti-TNF Naive Subjects with Active Psoriatic Arthritis II (INSPIRE 2)

This research study, called INSPIRE 2, is looking into a new treatment called Ilumetri for adults living with active psoriatic arthritis. This condition causes joint pain and swelling, and can also affect the skin. The study is specifically for people who haven't tried similar types of medication (called anti-TNF treatments) before. We want to find out how well Ilumetri works compared to a 'dummy' injection (placebo) in reducing symptoms like joint stiffness and skin rashes. We also want to understand if it's safe to use. Participants will be randomly given either Ilumetri or a placebo without knowing which one they receive. The main goal is to see if more people feel significantly better after 24 weeks on Ilumetri. Important parts of the study include regular check-ups and measurements of joint and skin changes.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Sun Pharmaceutical Industries Limited, Iqvia Biotech Limited, Labcorp Central Laboratory Services SARL

Enrolment target

108

Start

27 Jun 2024

Psoriatic Arthritis

What is this study about?

This study is called INSPIRE 2, and it's all about finding better ways to manage psoriatic arthritis. Psoriatic arthritis is a long-term condition that affects your joints, causing pain, swelling, and stiffness. It can also cause skin problems, like the red, scaly patches seen in psoriasis. If you have active psoriatic arthritis, it means your symptoms are flaring up and causing you discomfort.

The main goal of this study is to test a medicine called Ilumetri (also known as tildrakizumab). We want to see how effective and safe it is for people who have psoriatic arthritis but haven't yet tried certain other strong medications called anti-TNF treatments. Currently, Ilumetri is already approved for treating psoriasis, but we need to do more research to see if it can also help with the joint problems and other symptoms of psoriatic arthritis when used in this specific group of patients.

To make sure the results are fair and reliable, half the people in the study will be given Ilumetri, and the other half will receive a 'dummy' injection called a placebo. Neither you nor your doctor will know whether you're getting the active medicine or the placebo – this is called 'double-blind'. This helps us truly understand if any improvements are due to Ilumetri itself. We'll be carefully monitoring your progress over 24 weeks to see how much your symptoms improve, including common measures of joint health and skin condition.

Key takeaways

This study is for adults with active psoriatic arthritis.
It's testing a medicine called Ilumetri, especially for those new to similar treatments.
Participants will get either Ilumetri or a placebo injection.
Neither you nor your doctor will know which treatment you receive.
The main aim is to see if Ilumetri is safe and helps improve joint and skin symptoms over 24 weeks.
You'll have regular check-ups to monitor your progress.

Who may be eligible?

This study is looking for adults aged 18 or over. Both men and women can take part. A key requirement is that you must have active psoriatic arthritis, which means your condition is currently causing noticeable symptoms that affect your daily life.

Another important point is that you should not have previously taken a specific type of medicine called an anti-TNF treatment for your psoriatic arthritis. The researchers are particularly interested in how Ilumetri works in people who are new to these kinds of advanced therapies.

There will also be other health checks and criteria to ensure the study is safe for you and that the results will be clear. Your study doctor or nurse will discuss all specific requirements with you to see if this study is a good fit.

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.

Do you have active psoriatic arthritis?
Are you 18 years old or older?
Have you NOT taken anti-TNF medicines for your psoriatic arthritis before?
Are you able to attend regular clinic visits and appointments?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you'll be assigned to either receive the study medicine, Ilumetri, or a placebo (a dummy injection that looks identical). This will happen randomly, like flipping a coin, and neither you nor your study team will know which one you're getting. Both Ilumetri and the placebo are given as injections using a pre-filled syringe.

Throughout the study, you will have several visits to the clinic for assessments. These will include check-ups by a doctor or nurse, blood tests, and scans to monitor your joint health. You'll also be asked about your symptoms and how you're feeling. Some of the main things we will be tracking include how your joint pain and swelling change, your ability to do daily activities, and if you have psoriasis, how your skin clears up. The main part of the study where we compare the medicine to placebo will last for 24 weeks (about 6 months).

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as receiving a new treatment that might improve your psoriatic arthritis symptoms before it's widely available. You'll also receive careful monitoring of your health throughout the study. However, there are potential risks, including side effects from the study medicine or discomfort from injections and blood tests. You might also receive the placebo and not the active drug, meaning your condition might not improve. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (4)

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

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Unverified
Spain
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Unverified
Germany
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Unverified
Czechia
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Unverified
Poland

Common questions

What is psoriatic arthritis?

It's a type of arthritis that can affect people with psoriasis. It causes joint pain, swelling, and stiffness, and can also impact your skin and nails.

What is Ilumetri?

Ilumetri is a medicine that works by targeting specific parts of your immune system to help reduce the inflammation that causes psoriatic arthritis symptoms.

What does 'double-blind' mean?

It means neither you nor your study doctor or nurse will know if you are receiving the active medicine or a dummy injection (placebo). This helps ensure the study results are fair.

What is a placebo?

A placebo is an inactive substance or treatment that looks exactly like the study medicine but contains no active drug. It helps researchers compare the real drug's effects.

How long will I be in the study?

The main part of the study, where we compare the medicine to placebo, will last for 24 weeks (about 6 months).