Long-term Safety and Tolerability of Cenerimod in Adults With Systemic Lupus Erythematosus

Condition(s) studied

Investigational drug(s) / intervention(s)

Cenerimod: Film-coated tablets at a dose of 4 mg.

Study summary

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:

* Whether cenerimod causes any adverse effects ('side effects') when given on top of drugs already being given for systemic lupus erythematosus.
* How well cenerimod works to reduce symptoms of systemic lupus erythematosus when taken for up to 5 years.

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.

Eligibility

Primary outcome measure(s)

• Treatment-emergent adverse events — Day 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 events — Day 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 interest — Day 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

Trial sites (122)

+ 82 more sites — see the full list on the official registry below.

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