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

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What is this study about?

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.

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.

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.

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).

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Revmatologicky Ustav Prague Czechia
Hopitaux Universitaires Pitie Salpetriere Paris France
Centre Hospitalier Universitaire De La Reunion St Denis France
Unidade Local De Saude De Gaia/Espinho E.P.E. Vila Nova De Gaia Portugal
Spitalul Clinic Judetean De Urgenta Craiova Craiova Romania
Hospital Universitario Rio Hortega Valladolid Spain
Delta Health Care S.R.L. Bucharest Romania
Johannes Wesling Klinikum Minden Minden Germany
Unidade Local De Saude De Amadora Sintra E.P.E. Amadora Portugal
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k. Cracow Poland
Reumed Sp. z o.o. Lublin Poland
University Multiprofile Hospital For Active Treatment Kaspela EOOD Plovdiv Bulgaria
Malopolskie Badania Kliniczne Sp. z o.o. Cracow Poland
Vita Longa Sp. z o.o. Katowice Poland
Unidade Local De Saude Do Alto Ave E.P.E. Guimaraes Portugal
Athens Naval Hospital Athens Greece
Medaudio-Optica S.R.L. Ramnicu Valcea Romania
424 Military General Training Hospital Thessaloniki Greece
Hippokration Hospital Athens Greece
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy Bydgoszcz Poland
General University Hospital Of Larissa Larissa Greece
General University Hospital Of Patras Patras Greece
Unidade Local De Saude Da Guarda E.P.E. Guarda Portugal
Accellacare Espana S.L. Alcobendas Spain
Medyczne Centrum Hetmanska Poznan Poland
Pratia S.A. Skorzewo Poland
Twoja Przychodnia Poznańskie Centrum Medyczne Sp. z o.o. Poznan Poland
Universitaetsklinikum Leipzig AöR Leipzig Germany
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
Fraunhofer Institute for Translational Medicine and Pharmacology ITMP Frankfurt Germany
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
Medical Center 1 Sevlievo EOOD Sevlievo Bulgaria
Mmbhwxakp Ilnjqixsij Cqqeugrj Skitghxe Sqr z oeeu Warsaw Poland
Cmlcoti Mbmjqnv Dr Dynkgmqlae Sd Txcyqxhnx Aabdbcktw Npaemk Sgzcuc Brasov Romania
ioxirim sspqtu Brno Czechia
Eaueewjzrb Kvtvzui Sbvtcrp Thessaloniki Greece
Pwvy Tmebm Hphvhdzx Usydvgcmauso Sabadell Spain
Uvlkjyhwochzaolirbcwq Mnyhtpdg Aru Munster Germany
Psyawbk Sva z ojxy Katowice Poland
Lellw Gczwpqe Hcfkyspf Ow Arirft Athens Greece
Dytsccmghm Cocrjfolkxjf Ccpggh Edahun Orc Varna Bulgaria

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Recruiting
15.08.2024
Czechia Czechia
Recruiting
15.08.2024
France France
Recruiting
15.08.2024
Germany Germany
Recruiting
15.08.2024
Greece Greece
Recruiting
15.08.2024
Poland Poland
Recruiting
15.08.2024
Portugal Portugal
Recruiting
15.08.2024
Romania Romania
Recruiting
15.08.2024
Spain Spain
Recruiting
15.08.2024

Trial locations

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.

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.

Trial ID:
2024-514354-67-00
Protocol code:
ID-064A303
NCT ID:
NCT06475742
Trial Phase:
Therapeutic confirmatory (Phase III)

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