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Study on Long-Term Safety of Cenerimod for Adults with Moderate-to-Severe Systemic Lupus Erythematosus

Fast replyInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the long-term safety and tolerability of a medication called cenerimod in adults with systemic lupus erythematosus (SLE). SLE is a chronic autoimmune disease where the body's immune system mistakenly attacks healthy tissues, causing inflammation and damage to various parts of the body. The medication being tested, cenerimod, is taken as a film-coated tablet and is intended to be used alongside other ongoing treatments for SLE.

The purpose of this study is to evaluate how safe and well-tolerated cenerimod is when used over an extended period. Participants in the study will take a daily dose of 4 milligrams of cenerimod. The study is designed as an open-label, single-arm extension, meaning all participants will receive cenerimod, and there will be no comparison group receiving a placebo. The study will monitor participants for any side effects or adverse events that may occur during the treatment period.

Participants will be involved in the study for a maximum of 36 months, during which they will have regular check-ups to assess their health and any potential side effects from the medication. The study aims to gather information on the long-term effects of cenerimod to ensure it is a safe option for people living with systemic lupus erythematosus. This information will help healthcare providers make informed decisions about the use of cenerimod in treating SLE.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the participant must have completed a previous 12-month treatment period in a related study and must not have met any criteria that would stop treatment during that study.
Participants must have completed the last scheduled visit of the previous study. If unable to complete the last visit due to reasons beyond control, eligibility may be considered upon approval.
Step 2
Initial assessment
Participants will undergo an initial assessment, which includes signing an informed consent form and, for women of child-bearing potential, a negative pregnancy test is required.
Step 3
Treatment phase
Participants will receive cenerimod, a film-coated tablet, taken orally at a dosage of 4 mg.
The treatment is administered on top of existing background therapy for systemic lupus erythematosus (SLE).
Step 4
Ongoing monitoring
Participants will be monitored for any treatment-emergent adverse events, serious adverse events, and specific adverse events related to the treatment or SLE comorbidities.
Women of child-bearing potential will undertake monthly urine pregnancy tests during the study and for six months after discontinuing the study treatment.
Step 5
Completion of study
The study is expected to continue until May 2028, with ongoing assessments to ensure the long-term safety and tolerability of cenerimod.

Who can join the trial?

7 criteria

You must sign and date a form that shows you understand and agree to participate in the study before any study-related procedures begin.
You can be a male or female participant, aged between 18 and 75 years, with a diagnosis of systemic lupus erythematosus (SLE), which is a condition where the immune system attacks the body's own tissues.
You must have completed a 12-month treatment period in one of the previous related studies and not have met any criteria that would have stopped your treatment during that study.
You should have attended the last scheduled visit of the previous study. If you missed it for reasons beyond your control, you might still be eligible if the study sponsor approves.
If you are a woman who can have children, you must have a negative pregnancy test at the first visit.
You must agree to take monthly urine pregnancy tests from the second visit until six months after stopping the study treatment.
You must agree to use a highly effective method of birth control from the first visit until six months after stopping the study treatment.

Who cannot join the trial?

10 criteria

Patients who have a different condition than systemic lupus erythematosus cannot participate. Systemic lupus erythematosus is a disease where the body's defense system attacks its own tissues.
Patients who are not within the specified age range cannot participate. The age range is not specified here, but it is important for eligibility.
Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
Patients who have any other medical condition that might interfere with the study or pose a risk to the patient cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are currently participating in another clinical trial cannot participate.
Patients who have a history of drug or alcohol abuse that might interfere with the study cannot participate.
Patients who have had a recent infection or illness that might interfere with the study cannot participate.
Patients who have a known allergy to the study medication or any of its ingredients cannot participate.
Patients who have received certain medications or treatments that might interfere with the study cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Centre Hospitalier Universitaire De La Reunion
Verified
St Denis, France
Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.
Verified
Brasov, Romania
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Responsive
Plovdiv, Bulgaria

Trial locations

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Investigated drugs

Cenerimod is a medication being studied for its long-term safety and tolerability in adults with moderate-to-severe systemic lupus erythematosus (SLE). It is used in combination with other treatments that the patient is already receiving for SLE. The goal is to see how well patients can tolerate this medication over an extended period.

Cenerimod

What is already known about the treatment

Cenerimod – Cenerimod is administered orally in tablet form and is currently being studied in clinical trials for its long-term safety and tolerability in treating systemic lupus erythematosus (SLE). It is not yet widely available in medical practice, as it is still under investigation. The main therapeutic indication for cenerimod is moderate-to-severe SLE, a chronic autoimmune disease. At the molecular level, cenerimod works by modulating the immune system, specifically targeting certain receptors to reduce inflammation and immune response. It is classified pharmacologically as an immunomodulator.

Investigated diseases

Systemic lupus erythematosus – Systemic lupus erythematosus (SLE) is an autoimmune disease where the immune system mistakenly attacks healthy tissues in the body. It can affect various parts of the body, including the skin, joints, kidneys, brain, and other organs. The disease often presents with symptoms such as fatigue, joint pain, skin rashes, and fever. SLE is characterized by periods of illness, called flares, and periods of wellness, or remission. The exact cause of SLE is unknown, but it is believed to involve a combination of genetic, environmental, and hormonal factors. The progression of the disease can vary greatly among individuals, with some experiencing mild symptoms and others having more severe complications.