RecruitingPHASE2INTERVENTIONAL

A Clinical Study to Evaluate Ianalumab in Participants With Diffuse Cutaneous Systemic Sclerosis

This research study is testing a new medication called Ianalumab for people in the UK who have a condition called diffuse cutaneous systemic sclerosis, which is a rare, long-term autoimmune disease. The main goal is to find out if Ianalumab is effective and safe to use, and how well people can tolerate it, compared to a placebo (a dummy treatment with no active medicine). Participants will receive either Ianalumab or the placebo, and doctors will carefully monitor their health and symptoms over a long period. This study is in an earlier stage, known as Phase 2, meaning it's one of the first times the drug is being tested on a larger group of people to establish its effectiveness and side effects.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Novartis Pharmaceuticals

Enrolment target

200

Start

09 Oct 2024

Estimated completion

15 Jul 2030

Diffuse Cutaneous Systemic Sclerosis

What is this study about?

This study is about a new medicine called Ianalumab for a condition called diffuse cutaneous systemic sclerosis. This condition is a rare illness that affects the immune system, causing skin to thicken and sometimes affecting internal organs. Researchers want to see if Ianalumab can help people with this condition feel better and reduce their symptoms. They also want to make sure the medicine is safe to use.

In this study, some people will get the new medicine, while others will get a placebo. A placebo looks like the medicine but doesn't contain any active ingredients. This helps researchers compare the effects of the new drug fairly. The study will look at how well Ianalumab works, if it causes any side effects, and how easy it is for people to take.

Finding new and better treatments for diffuse cutaneous systemic sclerosis is really important. Studies like this help doctors understand more about these conditions and whether new medicines can make a real difference to people's lives.

Key takeaways

Tests a new medicine, Ianalumab, for diffuse cutaneous systemic sclerosis.
Compares Ianalumab to a placebo (dummy treatment).
Study lasts for approximately 2.5 to 3 years.
Participants must have a specific type of scleroderma and be within a certain age range.
Close medical monitoring throughout the study.
Participation is voluntary, and you can withdraw anytime.

Who may be eligible?

To join this study, participants need to be between 18 and 70 years old. You must have a confirmed diagnosis of diffuse cutaneous systemic sclerosis, and your condition should have started less than five years ago. Your skin thickening (measured by a special score) must be within a certain range.

Researchers are looking for people whose condition is currently 'active,' meaning it's causing problems. This could be if your condition started very recently, or if your skin thickening score has increased, or if you have new areas affected. Also, your blood tests might show signs of inflammation, or you might have lung involvement related to your scleroderma.

Finally, you must test positive for certain antibodies in your blood, which are tiny proteins related to your immune system. You can't join if you have other types of rheumatic diseases apart from diffuse cutaneous systemic sclerosis, or if your scleroderma is mainly in one small area.

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 between 18 and 70 years old?
Do you have a diagnosis of diffuse cutaneous systemic sclerosis?
Did your condition (not including Raynaud's phenomenon) start less than 5 years ago?
Is your condition currently considered active or getting worse?
Have you tested positive for specific types of antibodies related to your condition?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, here’s what you can expect:

* **Screening Period:** This lasts up to 6 weeks. During this time, you’ll have medical checks and tests to see if the study is right for you. * **Treatment Period 1:** This lasts for 52 weeks (about a year). You will receive either the study medicine, Ianalumab, or a placebo (a dummy treatment). You won't know which one you're getting. * **Treatment Period 2 (Open-label treatment):** This also lasts for 52 weeks. If you were getting the placebo before, you'll now get Ianalumab. If you were already on Ianalumab, you'll continue taking it. * **Post-Treatment Follow-up Period:** After your treatment finishes, you’ll have follow-up checks for at least 20 weeks, and up to 2 years, to see how you are doing after the last dose of medicine was given. Throughout the study, you'll have regular visits to the clinic for assessments, blood tests, and to discuss any changes in your health. The total time you could be involved in the study is around 2.5 to 3 years.

Potential risks and benefits

Potential benefits of joining the study include access to a new treatment that might help improve your condition, as well as close medical monitoring and care. However, because Ianalumab is a new medicine, there might be unknown side effects or it might not work for you. There's also a chance you could receive the placebo for the first part of the study. You might experience side effects from the medication or discomfort from tests like blood draws. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (127)

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

Arizona Arthritis and Rheumatology Research PLLC
Verified postcode
Mesa, United States· Recruiting
UCLA
Verified postcode
Los Angeles, United States· Recruiting
Hoag Hospital
Verified postcode
Newport Beach, United States· Recruiting
Clinical Res Of W Florida
Verified postcode
Clearwater, United States· Recruiting
GNP Research
Verified postcode
Cooper City, United States· Recruiting
IRIS Research and Development
Verified postcode
Plantation, United States· Recruiting
Sarasota Arthritis Res Ctr
Verified postcode
Sarasota, United States· Recruiting
University of Chicago Hospitals
Verified postcode
Chicago, United States· Recruiting
UMC New Orleans
Verified postcode
New Orleans, United States· Recruiting
Uni Of Michigan Health System
Verified postcode
Ann Arbor, United States· Recruiting
Wayne State University
Verified postcode
Detroit, United States· Recruiting
Clinical Research Inst of MI
Verified postcode
Saint Clair Shores, United States· Recruiting

Common questions

What is diffuse cutaneous systemic sclerosis?

It's a rare condition where your immune system mistakenly attacks your body, leading to thickened skin and sometimes affecting internal organs.

What is a placebo?

A placebo is a dummy treatment that looks like the real medicine but contains no active ingredients. It helps researchers compare results fairly.

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

For the first 52 weeks, you won't know. After that, everyone in the study will receive the active medicine.

How long will I be in this study?

Your involvement could last anywhere from about 2.5 to 3 years, including screening, treatment, and follow-up periods.

Can I leave the study at any time?

Yes, you are free to leave the study at any point, and it won't affect your regular medical care.

How to find out more

Novartis Pharmaceuticals

novartis.email@novartis.com 1-888-669-6682 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.