Long-term Safety and Tolerability of Cenerimod in Adults With Systemic Lupus Erythematosus
At a glance
Conditions
Where it's being run
122 sites across 30 statesStudy leadership
- Clinical Trials · STUDY_DIRECTOR · Viatris Innovation GmbH
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Inclusion
What this trial measures
- Treatment-emergent adverse eventsDay 1 (post dose) to a maximum of 5.5 years
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).
- Serious adverse eventsDay 1 (post dose) to a maximum of 5.5 years
Occurrence of serious adverse events up to the final study visit (maximum 5 years of study treatment plus 6-month safety follow-up period).
- Adverse events of special interestDay 1 (post dose) to a maximum of 5.5 years
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