A Phase 3 interventional study of Cenerimod in Lupus Erythematosus, Systemic, sponsored by Viatris Innovation GmbH. Enrolling by invitation at 122 sites in 26 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Viatris Innovation GmbH (part of Viatris Inc.) · Phase 3, Interventional, and Treatment
The goal of this clinical study is to learn about the long-term safety and tolerability of cenerimod in adult patients with moderate to severe symptoms of systemic lupus erythematosus.
The main questions it aims to answer are:
Participants taking part in this study will have already taken part in another study, where they received either cenerimod or placebo (look-alike substance containing no active drug) for 1 year.
In this clinical study approximately 680 participants will receive cenerimod (on top of drugs already being given for systemic lupus erythematosus) for up to 5 years.
Participants who completed the 12-month double-blind treatment period (cenerimod 4 mg or placebo) in either of the parent studies, ID-064A301 or ID-064A302, are eligible to participate in this extension study.
All participants in this study will receive cenerimod 4 mg for up to a maximum of 60 months (5 years). All participants may additionally receive standard of care treatment for systemic lupus erythematosus, i.e., at least 1 of the following: oral corticosteroids, antimalarial drugs, or immunosuppressant drugs.
The safety follow-up period starts on the day after the last dose of study treatment and ends after 6 months with the final study visit. Thus, the maximum duration of participation is 5.5 years.
Data collected in this extension study will allow an assessment of whether the safety and tolerability profile of cenerimod established in the controlled parent studies remains the same after a longer period of treatment.
1,207 studies on the registry are indexed under Lupus Erythematosus, Systemic; 405 are open to participants now.
This study's planned enrollment of 680 is above the median of 52 across 876 interventional studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →Viatris Innovation GmbH is the lead sponsor of 24 studies on the registry; 3 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 3 (30%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants with a diagnosis of systemic lupus erythematosus who:
Women of :
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive oral cenerimod once daily in addition to background systemic lupus erythematosus therapy, for up to 5 years.
Drug: Cenerimod
Film-coated tablets at a dose of 4 mg.
Also known as: ACT-334441
Treatment-emergent adverse events
Occurrence of treatment-emergent adverse events up to the final study visit (maximum 5 years of study treatment plus 6-month safety follow-up period).
Time frame: Day 1 (post dose) to a maximum of 5.5 years
Serious adverse events
Occurrence of serious adverse events up to the final study visit (maximum 5 years of study treatment plus 6-month safety follow-up period).
Time frame: Day 1 (post dose) to a maximum of 5.5 years
Adverse events of special interest
Occurrence of adverse events of special interest up to the final study visit (maximum 5 years of study treatment plus 6-month safety follow-up period). Adverse events of special interest include the anticipated risks of treatment with cenerimod, known class effects, and events that may be related to systemic lupus erythematosus comorbidities, i.e., adverse events related to: * Effects on heart rate and rhythm * Hypotension * Hypertension * Cardiovascular * Hepatobiliary disorders / liver enzyme abnormalities * Pulmonary * Eye disorders * Infections * Skin malignancies * Non-skin malignancies
Time frame: Day 1 (post dose) to a maximum of 5.5 years
Showing the first 100 of 122 sites across 26 countries. Choose a country and city above to see the rest.
Plan to share: No
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Studies of the drug tested here: Cenerimod
Lupus Erythematosus, Systemic →