Long-term safety of cenerimod in adults with lupus
Tests cenerimod's long-term safety in adults with moderate-to-severe systemic lupus erythematosus.
Plain-language title generated from the registry record
Registry title: Long-term Safety and Tolerability of Cenerimod in Adults With Systemic Lupus Erythematosus
Key facts
- Where
- Batumi and Tbilisi, GeorgiaSee the 11 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with systemic lupus erythematosus who finished one of two earlier cenerimod studies. All take cenerimod for up to 5 years on top of their usual lupus medicines.
- Age
- 18 to 75 years
- Sex
- Women and men
- Disease stage
- Moderate-to-severe systemic lupus erythematosus (SLE).
- Earlier treatment
- Must have finished the 12-month double-blind treatment period of study ID-064A301 or ID-064A302 and not met any treatment stopping criteria there.
Main reasons for not taking part
- Took less than 80% of the planned doses in the earlier study, or missed most site visits, without a medical reason
- Lupus-driven kidney disease, lupus of the central nervous system, or active severe or unstable neuropsychiatric lupus needing stronger treatment than the protocol allows
- Women who can have children and plan to become pregnant before the final study visit
- Active or latent tuberculosis (only if local rules ask for this)
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06475742, who can take part
Where in Georgia
- LTD "New Plasma Clinic"Batumi, GeorgiaNo longer taking part
- Aversi Clinic LTDTbilisi, GeorgiaNo longer taking part
- Institute of Clinical Cardiology, Ltd.Tbilisi, GeorgiaNo longer taking part
- LLC "Innova"Tbilisi, GeorgiaNo longer taking part
- LTD "Tbilisi Central Hospital"Tbilisi, GeorgiaNo longer taking part
- LTD Tbilisi Heart CenterTbilisi, GeorgiaNo longer taking part
- Ltd. Mtskheta Street ClinicTbilisi, GeorgiaNo longer taking part
- Medi Club Georgia Ltd.Tbilisi, GeorgiaNo longer taking part
- National Institute of Endocrinology, LTD,Tbilisi, GeorgiaNo longer taking part
- Tbilisi Heart and Vascular Clinic LTDTbilisi, GeorgiaNo longer taking part
- The First Medical Center LTDTbilisi, GeorgiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Viatris Innovation GmbH
- Trial code
- NCT06475742EU 2024-514354-67-00
- Record updated
- 11 September 2026
- Original description
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.Read full original descriptionShow less
A Phase 3, Multicenter, Open-label, Single-arm, Extension Study to Evaluate the Long-term Safety and Tolerability of Cenerimod in Adult Subjects With Moderate-to-Severe Systemic Lupus Erythematosus (SLE) on Top of Background Therapy
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.
Inclusion: Signed and dated informed consent form prior to any study-mandated procedure; Participants with a diagnosis of systemic lupus erythematosus who:; Completed the 12-month double-blind treatment period of either of the parent studies (ID-064A301, ID-064A302); Did not meet any study treatment stopping criteria during the parent study; Completed the last scheduled visit of the parent study. Participants who did not complete the last scheduled visit for reasons beyond their control may be eligible for this study upon approval by the sponsor; Women of child-bearing potential:; Negative pregnancy test at Visit 1; Agreement to undertake monthly urine pregnancy tests from Visit 2 up to 6 months after study treatment discontinuation; Agreement to use a highly effective method of contraception from Visit 1 up to 6 months after study treatment discontinuation.
Exclusion: Systemic lupus erythematosus driven renal disease, central nervous system lupus, or active severe or unstable neuropsychiatric systemic lupus erythematosus where, in the judgment of the investigator, protocol-specific systemic lupus erythematosus background therapy is insufficient, and the use of a more aggressive therapeutic approach or other treatments not permitted in the protocol is indicated; Confirmed active or latent tuberculosis (applicable only if requested by local regulations); Poor compliance with study-mandated procedures during the parent study (ID-064A301 or ID-064A302), e.g., took less than 80% of the planned doses of double-blind study treatment; or did not attend a majority of the site visits, unless there was a medically justified reason as judged by the investigator; Women of child-bearing potential planning to become pregnant up to the final study visit; Judged not eligible to participate by the investigator, for any other reason.