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

NCT06475742 · Status: ENROLLING_BY_INVITATION · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 680

Last updated 2026-05-06

No results posted yet for this 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 at least 1 year and up to 3 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 at least 1 year and up to 3 years.

Conditions

  • Lupus Erythematosus, Systemic

Interventions

DRUG

Cenerimod

Film-coated tablets at a dose of 4 mg.

Sponsors & Collaborators

  • Viatris Innovation GmbH

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Viatris Innovation GmbH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-30
Primary Completion
2028-05-31
Completion
2028-05-31
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • Bulgaria
  • Chile
  • Colombia
  • Czechia
  • Georgia
  • Germany
  • Greece
  • Mexico
  • Peru
  • Philippines
  • Poland
  • Portugal
  • Puerto Rico
  • Romania
  • Serbia
  • South Africa
  • South Korea
  • Spain
  • Taiwan
  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06475742 on ClinicalTrials.gov