Long-term Safety and Tolerability of Cenerimod in Adults With Systemic Lupus Erythematosus (NCT06475742) | Clinical Trial Compass
By InvitationPhase 3
Long-term Safety and Tolerability of Cenerimod in Adults With Systemic Lupus Erythematosus
United States680 participantsStarted 2024-07-30
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Signed and dated informed consent form prior to any study-mandated procedure.
✓. Participants with a diagnosis of systemic lupus erythematosus who:
✓. Women of child-bearing potential:
Exclusion criteria
✕. 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.
✕. 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.
✕. 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.
What they're measuring
1
Treatment-emergent adverse events
Timeframe: Day 1 (post dose) to a maximum of 3.5 years
2
Serious adverse events
Timeframe: Day 1 (post dose) to a maximum of 3.5 years
3
Adverse events of special interest
Timeframe: Day 1 (post dose) to a maximum of 3.5 years