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Cielo study

Aims: The purpose of this study is to assess the effectiveness and safety of satralizumab in participants with anti-NMDAR and anti-LGI1 encephalitis.

Institution: This study is sponsored by Hoffmann-La Roche, one of the world’s largest biotech companies

Location: This trial runs in 11 countries: Argentina, Austria, China, Czechia, Denmark, Italy, Japan, Poland, South Korea, Taiwan and United States

What key criteria should participants meet?

  • Be at least 12 years old and have been diagnosed with anti-NMDAR OR at least 18 years old and be diagnosed with anti-LGI1
  • Symptoms started no longer than nine months ago.

Who cannot take part?

  • People may not be able to take part in this trial if they have a history of cancer or certain other medical conditions, or if they have been treated with particular medications.
  • People who are pregnant or breastfeeding will not be able to take part in this clinical trial.

What will taking part involve for the participants?

Everyone who joins this clinical trial will be put into one of two groups randomly and given either satralizumab or placebo (substance with no active ingredients) as a subcutaneous injection at weeks 0, 2 and 4, and then every four weeks until week 52. Participants will have a 50% chance of being placed in either the satralizumab or placebo group. Comparing results from the different groups helps the researchers know whether any changes seen are a result of the drug or occurring by chance.

Participants will be seen by the clinical trial doctor every four weeks to be given their clinical trial treatment. These hospital visits will include checks to see how the participant is responding to the treatment and any side effects they may be having.

How long will the trial last?

Depending on whether participants choose to take part in an optional extension period of the trial (which will last for at least two years), their total time in the clinical trial may last for up to five years (including follow-up appointments). Participants are free to stop trial treatment and leave the clinical trial at any time.

Will participant expenses be reimbursed?

You may be reimbursed for any reasonable travel expenses

How do I take part?

If you are interested in taking part, or you think someone you care about may be suitable for the study, talk to your doctor. They may be able to discuss the study with you and talk you through the potential benefits and risks of being involved before you make your decision about participating.

For more information about the study or if you would like to contact a centre in your country https://forpatients.roche.com/en/trials/autoimmune-disorder/autoimmune-encephalitis/a-study-to-evaluate-the-efficacy–safety–pharmacokinet-99237.html

Page Created: 19 January 2024
Last Modified: 29 January 2024
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