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Long-term safety and tolerability of cenerimod in adults with systemic lupus erythematosus (OPUS OLE)
EU CTIS ID: 2024-514354-67-00
What this study is testing
The primary objective of the study is to assess the long-term safety and tolerability of cenerimod 4 mg on top of background therapy in subjects with systemic lupus erythematosus (SLE).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed and dated informed consent form prior to any study-mandated procedure.
- Male and female participants (aged 18-75 years) 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 maybe eligible for this study upon approval by the sponsor.
- For 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.
You likely can't join if
- 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.
- Confirmed active or latent tuberculosis (applicable only if requested by local regulations).
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- Georgia
- Argentina
- Taiwan
- Mexico
- United Kingdom
- Peru
- Puerto Rico
- China
- United States
- Colombia
- Serbia
- Ukraine
- Brazil
- South Africa
- Chile
- Philippines
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Republic of; Georgia; Argentina; Taiwan; Mexico; United Kingdom and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.