Active not recruitingPHASE3INTERVENTIONAL

A Research Study to Evaluate the Efficacy and Safety of Cenerimod in Subjects Suffering From Systemic Lupus Erythematosus

This research study is looking into a new medicine called cenerimod for adults who have moderate to severe Systemic Lupus Erythematosus (SLE), also known simply as lupus. The main goal is to find out how well cenerimod works to improve lupus symptoms when added to the medicines patients are already taking. Researchers also want to check if cenerimod is safe to use. About 420 people will take part, with half receiving cenerimod and the other half receiving a dummy pill (placebo) for 12 months, all while continuing their usual lupus treatment. This will help doctors understand its potential benefits and any side effects.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Viatris Innovation GmbH

Enrolment target

451

Start

26 Jun 2023

Estimated completion

01 May 2027

Lupus Erythematosus, Systemic

What is this study about?

This study is about a medicine called cenerimod and its potential to help people with Systemic Lupus Erythematosus (SLE). SLE, often just called lupus, is a long-term condition where the body's immune system mistakenly attacks its own tissues and organs. This can cause a range of symptoms, from joint pain and skin rashes to problems with kidneys and other organs. Currently, there are treatments to manage lupus, but researchers are always looking for new and better options.

Here, doctors want to see if adding cenerimod to the treatment plan that patients are already on can lead to fewer symptoms and better health. They are specifically focusing on adults whose lupus symptoms are moderate to severe. It’s important to find new treatments because lupus can affect people differently, and what works for one person might not work as well for another.

By comparing cenerimod to a 'dummy' pill (placebo), the study aims to clearly show if any improvements are due to cenerimod itself. This type of study helps make sure any new medicine is truly effective and safe before it can be widely used. Your participation could help advance our understanding of lupus and potentially lead to new ways to manage this condition for many others.

Key takeaways

The study is for adults with moderate to severe lupus (SLE).
It tests a new medicine called cenerimod alongside your usual lupus treatment.
Half of participants will get cenerimod, half a dummy pill (placebo).
The study will last about 12 months.
It aims to see if cenerimod is safe and helps reduce lupus symptoms.

Who may be eligible?

To join this study, you need to be an adult between 18 and 75 years old and have had a diagnosis of Systemic Lupus Erythematosus (SLE) for at least six months. Your lupus symptoms should be active and moderately severe, as judged by specific medical scores.

You also need to be taking certain medicines for your lupus already. These could include anti-malarials (like hydroxychloroquine), mycophenolate mofetil or mycophenolic acid, azathioprine, methotrexate, specific steroid doses (like prednisone), or belimumab. The timing of when you started these medicines is also important.

For women who could become pregnant, you would need to have a negative pregnancy test and agree to use reliable contraception throughout the study and for six months afterwards. The study team will check all these details carefully to make sure it's the right fit 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 between 18 and 75 years old?
Have you been diagnosed with Systemic Lupus Erythematosus (SLE) for at least 6 months?
Are your lupus symptoms currently active and moderately severe?
Are you currently taking one of the specified lupus medications (e.g., anti-malarials, specific steroids, belimumab)?
If you are a woman, could you become pregnant and are you willing to use contraception during the study?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be in it for about 12 months. Throughout this time, you'll continue taking your usual lupus medicines. In addition, you'll either receive the study medicine, cenerimod, or a placebo (a dummy pill that looks like the active medicine but contains no active drug). You won't know which one you're receiving, and neither will your study doctor, to ensure fair results. You'll need to attend regular clinic visits for check-ups, assessments of your lupus symptoms, and to have blood or urine tests. These visits help the research team keep track of your health, how your lupus is doing, and if the study medicine is having any effects.

Potential risks and benefits

Taking part in a study like this might offer some potential benefits, such as receiving a new medicine that could improve your lupus symptoms or getting very close monitoring of your health. However, there's no guarantee that you will receive the active study medicine or that it will help you. Like all medicines, cenerimod might have side effects, which the study will carefully monitor. You will be told about any known risks before you agree to participate. It's very important to remember that joining a study is always your choice, and you are free to withdraw at any time, for any reason, without it affecting your usual medical care.

Locations (147)

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

Tucson Clinical Research Institute, LLC
Verified postcode
Tucson, United States
UCSD Perlman Medical Offices
Verified postcode
La Jolla, United States
Amicis Research Center
Verified postcode
Northridge, United States
Hope Clinical Trials, Inc.
Verified postcode
Coral Gables, United States
Vital Pharma Research
Verified postcode
Hialeah, United States
Tectum Medical Research
Verified postcode
Hollywood, United States
Alloy Clinical Research, LLC
Verified postcode
Kissimmee, United States
Allied Biomedical Research Institute
Verified postcode
Miami, United States
D&H National Research Centers INC
Verified postcode
Miami, United States
Professional research Center INC
Verified postcode
Miami, United States
San Marcus Research Clinic, Inc.
Verified postcode
Miami Lakes, United States
Tandem Clinical Research
Verified postcode
Marrero, United States

Common questions

What is Systemic Lupus Erythematosus (SLE)?

SLE is a long-term illness where your body's immune system attacks its own tissues, causing problems in many parts of the body.

What is cenerimod?

Cenerimod is a new medicine being tested to see if it helps reduce lupus symptoms.

What is a placebo?

A placebo is a 'dummy pill' that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers compare the real medicine's effects.

How long will the study last?

If you join, you will be part of the study for about 12 months.

Can I stop participating in the study if I change my mind?

Yes, you can leave the study at any time, for any reason, without affecting your medical care.