Study on the Effects 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 a disease called systemic lupus erythematosus (SLE), which is a condition where the immune system mistakenly attacks healthy tissues in the body, causing inflammation and damage. The study is testing a new oral medication called cenerimod, which is taken as a film-coated tablet. The purpose of the study is to evaluate how effective cenerimod is at reducing the activity of SLE compared to a placebo. Participants in the study will continue their usual background therapy for SLE while taking the study medication.

The study will involve adult participants who have moderate to severe SLE. Over the course of the study, participants will be randomly assigned to receive either cenerimod or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication and who is receiving the placebo. This helps ensure that the results are not biased. The study will last for about 12 months, during which time the participants’ health and response to the medication will be closely monitored.

Throughout the study, researchers will assess the participants’ response to the treatment using specific measures, such as the Systemic Lupus Erythematosus Responder Index (SRI-4) and the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA). These assessments will help determine if cenerimod is effective in reducing the symptoms and activity of SLE. The study aims to provide valuable information about the safety and potential benefits of cenerimod for people living with SLE.

1 joining the study

Upon joining the study, you will be asked to sign an informed consent form. This form confirms that you understand the study and agree to participate.

You will undergo a screening process to ensure you meet the necessary criteria for the study. This includes confirming a diagnosis of systemic lupus erythematosus (SLE) made at least six months prior, and a specific score on the disease activity index.

2 initial assessments

You will have initial assessments to evaluate your current health status. This includes a physical examination and laboratory tests to check for specific biomarkers related to SLE.

Your current medications for SLE will be reviewed to ensure they meet the study’s requirements.

3 randomization

If you meet the criteria, you will be randomly assigned to receive either the study medication, cenerimod, or a placebo. This process is called randomization and ensures that the study results are unbiased.

You will not know whether you are receiving cenerimod or the placebo, as the study is double-blind.

4 medication administration

You will take the study medication in the form of a film-coated tablet. The dosage is 4 mg of cenerimod, taken orally once a day.

The duration of the medication administration is up to 12 months, during which you will continue your regular SLE background therapy.

5 regular follow-up visits

You will have regular follow-up visits to monitor your health and the effects of the medication. These visits will include physical exams, laboratory tests, and assessments of your SLE symptoms.

You will be asked to report any side effects or changes in your health during these visits.

6 end of treatment

At the end of the 12-month treatment period, you will have a final assessment to evaluate the overall effects of the medication on your SLE.

You will be asked to continue monitoring your health and report any changes for a specified period after the study ends.

Who Can Join the Study?

Must sign an Informed Consent Form before any study-related procedures.
Must have been diagnosed with Systemic Lupus Erythematosus (SLE) at least 6 months before joining the study. SLE is an autoimmune disease where the immune system attacks its own tissues.
Must have a certain level of disease activity, measured by a score called mSLEDAI-2K. This score should be 6 or higher, with at least 4 points related to joint or skin symptoms like muscle inflammation, joint pain, rash, hair loss, or mouth sores.
Must be currently taking one or more of the following medications for SLE:
- Antimalarials (up to 400 mg/day hydroxychloroquine, 500 mg/day chloroquine, or 100 mg/day quinacrine)
- Mycophenolate mofetil (up to 2 g/day) or mycophenolic acid (up to 1.44 g/day)
- Azathioprine (up to 2 mg/kg/day)
- Methotrexate (up to 25 mg/week)
- Oral Corticosteroids (OCS): If this is the only medication, the dose should be between 7.5 mg/day and 30 mg/day prednisone or equivalent. If not the only medication, up to 30 mg/day prednisone or equivalent.
- Belimumab (up to 10 mg/kg every 4 weeks intravenously or 200 mg/week subcutaneously)
Must have started treatment with antimalarials, mycophenolate mofetil, mycophenolic acid, azathioprine, methotrexate, or belimumab at least 90 days before joining the study.
Must have started treatment with oral corticosteroids at least 30 days before joining the study.
For women who can become pregnant:
- Must have a negative pregnancy test before joining the study.
- Must agree to take monthly pregnancy tests during the study and for 6 months after stopping the study treatment.
- Must agree to use a highly effective method of birth control during the study and for 6 months after stopping the study treatment.
Must have a certain level of disease activity, measured by a score called mSLEDAI-2K, with at least 4 points related to joint or skin symptoms.
Must have a certain level of disease severity, measured by a system called BILAG, with a Grade B in 2 or more organ systems or a Grade A in 1 or more organ system.
Must have a Physician’s Global Assessment (PGA) score of 1.0 or higher on a scale from 0 to 3.
Must have at least one of the following blood test results showing active SLE:
- Elevated Anti-dsDNA antibodies
- Antinuclear antibodies with a titer of at least 1:160
- Elevated Anti-Smith antibody
Must be currently taking one or more of the following medications for SLE, which must be stable for at least 30 days before joining the study (except oral corticosteroids, which must be stable for at least 15 days):
- Antimalarials (up to 400 mg/day hydroxychloroquine, 500 mg/day chloroquine, or 100 mg/day quinacrine)
- Mycophenolate mofetil (up to 2 g/day) or mycophenolic acid (up to 1.44 g/day)
- Azathioprine (up to 2 mg/kg/day)
- Methotrexate (up to 25 mg/week)
- Oral Corticosteroids (OCS): If this is the only medication, the dose should be between 7.5 mg/day and 30 mg/day prednisone or equivalent. If not the only medication, up to 30 mg/day prednisone or equivalent.
- Belimumab (up to 10 mg/kg every 4 weeks intravenously or 200 mg/week subcutaneously)
Women who can become pregnant must have a negative urine pregnancy test before joining the study.

Who Cannot Join the Study?

Patients with other serious health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have had a recent infection that required treatment with antibiotics.
Patients who have received any other investigational drug within the last 30 days.
Patients with a history of drug or alcohol abuse within the past year.
Patients who have had a recent vaccination within the last 4 weeks.
Patients with a known allergy to the study medication or its ingredients.
Patients who have had a major surgery within the last 8 weeks.
Patients with a history of cancer, except for certain types of skin cancer.
Patients who are unable to comply with the study procedures.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country
Iwona Chlebicka Malwa-Med Iwona Chlebicka	Wroclaw	Poland
Ambulatories For Specialized Outpatient Medical Help Medical Center Kyuchuk Parizh OOD	Plovdiv	Bulgaria
Oncopole Claudius Regaud	Toulouse	France
Acibadem City Clinic Diagnostic And Consultation Center Tokuda EAD	Sofia	Bulgaria

Other Sites

Site Name	City	Country
Hopitaux Universitaires Pitie Salpetriere	Paris	France
Centre Hospitalier Universitaire De La Reunion	St Denis	France
Spitalul Clinic Judetean De Urgenta Craiova	Craiova	Romania
Delta Health Care S.R.L.	Bucharest	Romania
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
Athens Naval Hospital	Athens	Greece
Medaudio-Optica S.R.L.	Ramnicu Valcea	Romania
Dkc 1 Ruse EOOD	Ruse	Bulgaria
424 Military General Training Hospital	Thessaloniki	Greece
University Multiprofile Hospital For Active Treatment Saint Georgi EAD	Plovdiv	Bulgaria
Hippokration Hospital	Athens	Greece
General University Hospital Of Larissa	Larissa	Greece
Pratia S.A.	Skorzewo	Poland
General University Hospital Of Patras	Patras	Greece
Ko-Med Centra Kliniczne Sp. z o.o.	Zamosc	Poland
Medical Center Artmed Ltd.	Plovdiv	Bulgaria
INTER CLINIC Piotr Adrian Klimiuk	Bialystok	Poland
Medical Center 1 Sevlievo EOOD	Sevlievo	Bulgaria
Crzpfgp Mqbjyip Dx Dhqpjaigga Ss Ticpbqnnx Aszzaahaq Ndjuqq Spflum	Brasov	Romania
Dqozaynkvv Ccanwjbrzrwx Cyzapr (siug &ngkxtsosqhn Axqrlhweyqs Exjt	Sofia	Bulgaria
Euteojlmky Kfpcknf Smdeejt	Thessaloniki	Greece
Ldket Gxevpun Hcylhssc Ok Awnjoj	Athens	Greece
Pclwutp Sur z opob	Katowice	Poland
Dnvdgrhjch Csyejlezwvqb Cpqoxg Eruepm Oun	Varna	Bulgaria
Udlkpdpmec Gkpipay Hajxdzad Apuhofl	Athens	Greece

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	08.06.2023
France	Not recruiting	08.06.2023
Greece	Not recruiting	08.06.2023
Poland	Not recruiting	08.06.2023
Romania	Not recruiting	08.06.2023

Trial locations

Investigated drugs:

Cenerimod

Cenerimod is a medication being studied for its potential to help people with systemic lupus erythematosus (SLE), which is a condition where the immune system attacks the body’s own tissues. This medication works by targeting a specific part of the immune system to reduce inflammation and disease activity. The goal of using cenerimod in this trial is to see if it can effectively lower the symptoms and improve the quality of life for people with moderate-to-severe SLE when used alongside their usual treatments.

Investigated diseases:

Systemic lupus erythematosus

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. Over time, SLE can lead to inflammation and damage in the affected organs. The severity and progression of symptoms can vary widely among individuals. Flare-ups of symptoms can occur, followed by periods of remission.

Trial ID:

2024-515870-28-00

Protocol code:

ID-064A301

NCT ID:

NCT05648500

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Cenerimod for Adults with Moderate to Severe Systemic Lupus Erythematosus

What is this study about?

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