Cielo study
A clinical trial to assess the effectiveness and safety of the drug satralizumab in patients with encephalitis, sponsored by Hoffmann-La Roche, one of the world’s largest biotech companies
Are you an encephalitis patient or a family member? Visit the CIELO Trial site for patients HERE
Are you a medical professional looking to refer a patient to the trial? Click the CIELO trial site for medical professionals HERE
Keep scrolling to see common FAQs relating to this trial!
Aim of the trial
The purpose of this study is to assess the effectiveness and safety of satralizumab in participants with anti-NMDAR encephalitis.
Trial locations
The trial currently has 67 medical centres that are actively recruiting, worldwide.
Click the link to find a medical centre near you!
Participant criteria
Be at least 12 years old and have been diagnosed with anti-NMDAR.
Symptoms started no longer than nine months ago.
Click the button below to read more about the CIELO 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 via 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.
Participants will be seen by the clinical trial doctor every four weeks to be given their clinical trial treatment and check to see how they are responding to the treatment.
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.
How to take part or find out more?
Save the trial to share with your doctor, click the button below to share the study number with your healthcare team.
Trial FAQs
Satralizumab is a recombinant humanized Imuunoglobulin 2 (IgG2) against the human IL-6 receptor. IL-6 is a cytokine (protein) that mediates a number of inflammatory processes that is involved in the pathogenesis of several autoantibody-mediated disorders of the nervous system, including autoimmune encephalitis (AIE).
Your doctor should be able to thoroughly discuss with you all medications that are allowed or prohibited during the study. These details are available in the study protocol which has been made available to your treating team.
Visits last between 1-5 hours. These additional details will be available in the informed consent form that all participants will have read and signed prior to study participation
Yes, certain medications are permitted alongside the study drug while you are enrolled in the study. Additionally, "rescue" therapy—which includes all commonly used treatments for AIE, such as rituximab—is allowed at any point during the study if your condition worsens or does not improve.
Satralizumab (ENSPRYNG) has been approved by multiple Health Authorities (HAs) for the treatment of NMOSD. In addition, satralizumab has been studied or being studied in patients with genralized myasthenia gravis (gMG), Myelin Oligodendrocyte Glycoprotein Antibody Disease (MOGAD), and Thyroid Eye Disease (TED). As side effects of the drug may vary from person to person, it is important to discuss all potential effects of satralizumab with your treating team prior to study entry.
During each study visit, the patient will undergo several physical and clinical assessments. These will include lab draws, drug administration, and evaluations of the patient’s physical, cognitive, and overall well-being.
Depending on your location and travel times to and from the clinical site, travel expenses and other associated costs (e.g., meals) may be reimbursed. It’s important to discuss any logistical barriers that could limit your participation in the study with your treating team, so that these issues can addressed early.
All participants that complete 12 months of the double blind study period are eligible to participate in the extension period, which includes the option of receiving open label satralizumab (open label is where both the researchers and participants know which treatment is being administered).