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Monoclonal Antibodies
Satralizumab for Autoimmune Encephalitis (Cielo Trial)
Phase 3
Recruiting
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
N-methyl-D-aspartic acid receptor (NMDAR) AIE Cohort: Age >=12 years, Diagnosis of probable or definite NMDAR encephalitis
Leucine-rich glioma-inactivated 1 (LGI1) AIE Cohort: Age >=18 years, Diagnosis of LGI1 encephalitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from week 52 up to 2 years
Awards & highlights
Cielo Trial Summary
This trial will test a new drug to treat two types of brain inflammation: NMDAR and LGI1 encephalitis.
Who is the study for?
This trial is for individuals with autoimmune encephalitis, specifically anti-NMDAR or LGI1 encephalitis. Eligible participants must have had symptoms start within the last 9 months and cannot be pregnant or breastfeeding. They should not have a history of certain diseases like tuberculosis, drug abuse, or severe allergies to biologics.Check my eligibility
What is being tested?
The study tests satralizumab's effectiveness and safety in treating autoimmune encephalitis compared to a placebo. It will also look at how the body processes the drug (pharmacokinetics) and its effects on disease activity (pharmacodynamics).See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system such as infections, digestive issues that could lead to complications like GI perforation, allergic responses due to biological agents, and possibly changes in liver function.
Cielo Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 12 or older with a diagnosis of NMDAR encephalitis.
Select...
I am 18 or older with LGI1 encephalitis.
Cielo Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 52, 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 52, 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1: Proportion of participants with mRS score improvement ≥ 1 from baseline and no use of rescue therapy at Week 24
Part 2: Percentage of participants with adverse events
Secondary outcome measures
Part 1: Change in CASE score from baseline at Week 24
Part 1: MOCA total score at Week 24
Part 1: Percentage of participants with adverse events
+5 moreSide effects data
From 2021 Phase 3 trial • 85 Patients • NCT0202888421%
Upper respiratory tract infection
18%
Nasopharyngitis
15%
Headache
13%
Anaemia
13%
Urinary tract infection
13%
Alanine aminotransferase increased
11%
Alopecia
11%
Hyperlipidaemia
11%
Vertigo
11%
Chest discomfort
11%
Complement factor decreased
11%
Conjunctivitis
10%
Leukopenia
10%
Lymphopenia
8%
Conjunctival haemorrhage
8%
Diarrhoea
8%
Arthralgia
8%
Oral herpes
8%
Cough
8%
Eczema
6%
Oral candidiasis
6%
Bradycardia
6%
Hypertransaminasaemia
6%
Retinal haemorrhage
6%
Hypofibrinogenaemia
6%
Left ventricle outflow tract obstruction
6%
Blepharospasm
6%
Conjunctival deposit
6%
Dry eye
6%
Glaucoma
6%
Excoriation
6%
Blood urine
6%
Protein urine present
6%
Dehydration
6%
Amenorrhoea
6%
Pharyngeal erythema
6%
Acne
6%
Intervertebral disc protrusion
6%
Muscle spasticity
6%
Blood alkaline phosphatase increased
6%
Polycythaemia
6%
Oedema peripheral
6%
Bacteriuria
6%
Pyelonephritis
6%
Respiratory tract infection
6%
Wound
6%
Epistaxis
6%
Musculoskeletal stiffness
6%
Large intestine polyp
6%
Pancreatitis acute
6%
Feeling abnormal
6%
Hepatic function abnormal
6%
Arthropod sting
6%
Feeling hot
6%
Pelvic fracture
6%
Osteoarthritis
6%
Nephrolithiasis
6%
Platelet count decreased
6%
Cataract
6%
Chills
6%
Contusion
6%
Serum ferritin decreased
6%
Dyspepsia
6%
Onychomycosis
6%
Viral upper respiratory tract infection
6%
Upper respiratory tract inflammation
6%
Plicated tongue
6%
Compression fracture
6%
Urobilinogen urine increased
6%
Neck pain
6%
Malaise
6%
Angina pectoris
6%
Abdominal distension
6%
Cellulitis
6%
Enterocolitis infectious
6%
Pneumonia
6%
Joint injury
6%
Weight increased
6%
Myopathy toxic
6%
Spinal osteoarthritis
6%
Epilepsy
6%
Lower limb fracture
6%
Low density lipoprotein increased
6%
Weight decreased
6%
Iron deficiency
6%
Erythema
6%
Rash pruritic
6%
Spinal pain
6%
Intercostal neuralgia
6%
Eye pruritus
6%
Panic disorder
5%
Pain in extremity
5%
Ear discomfort
5%
Neutropenia
5%
Bronchitis
5%
Rib fracture
5%
Constipation
5%
Gastritis
5%
Fall
5%
Cystitis
5%
Blepharitis
5%
Hypocomplementaemia
5%
Laryngitis
5%
Oropharyngeal pain
5%
Dental caries
5%
Sinusitis
5%
Thermal burn
5%
Dyslipidaemia
5%
Hypercholesterolaemia
5%
Myalgia
5%
Anxiety
5%
Flushing
5%
Hypertension
5%
Blood fibrinogen decreased
5%
Blood fibrinogen increased
5%
Blood pressure increased
5%
Prothrombin time prolonged
5%
Rhinorrhoea
5%
Rash
5%
Muscle spasms
3%
Lymphocyte percentage increased
3%
Cervical dysplasia
3%
Gait disturbance
3%
Vomiting
3%
Influenza
3%
Upper limb fracture
3%
Tonsillitis
3%
Haemoglobin decreased
3%
Toothache
3%
Pharyngitis
3%
Dizziness
3%
Hordeolum
3%
Haemorrhoids
3%
Insomnia
3%
Periodontitis
3%
Neutrophil count decreased
3%
White blood cell count decreased
3%
Back pain
3%
Parkinsonism
3%
White blood cell count increased
3%
Hepatitis E
3%
Spinal compression fracture
3%
Large intestine infection
3%
Forearm fracture
3%
Lumbar spinal stenosis
3%
Neuromyelitis optica pseudo relapse
3%
Iron deficiency anaemia
3%
Abdominal pain upper
3%
Rhinitis
3%
Aspartate aminotransferase increased
3%
Urticaria
3%
Blood creatine phosphokinase increased
3%
Lymphocyte count decreased
3%
Non-cardiac chest pain
3%
Neutrophil count increased
3%
Neutrophil percentage increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + Baseline Treatment Double Blind Period
Satralizumab + Baseline Treatment Open Label Period
Satralizumab + Baseline Treatment Double Blind Period
Placebo + Baseline Treatment Open Label Period
Satralizumab Open-Label Period
Cielo Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: NMDAR autoimmune encephalitis (AIE) cohortExperimental Treatment1 Intervention
Adults and adolescents with definite or probable NMDAR encephalitis
Group II: LGI1 AIE cohortExperimental Treatment1 Intervention
Adults with LGI1 encephalitis
Group III: NMDAR autoimmune encephalitis (AIE) Placebo cohortPlacebo Group1 Intervention
Adults and adolescents with definite or probable NMDAR encephalitis
Group IV: LGI1 AIE Placebo cohortPlacebo Group1 Intervention
Adults with LGI1 encephalitis
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Satralizumab
2014
Completed Phase 3
~180
Find a Location
Who is running the clinical trial?
Chugai Pharmaceutical Co.UNKNOWN
3 Previous Clinical Trials
270 Total Patients Enrolled
Hoffmann-La RocheLead Sponsor
2,430 Previous Clinical Trials
1,089,258 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,580 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your test results are not normal when you are screened for the study.Other reasons for the symptoms you're experiencing.I do not have any serious uncontrolled diseases.My autoimmune encephalitis symptoms started less than 9 months ago.I currently have or recently had a serious infection.You have recently developed or have not responded well to treatment for an immune-related side effect.You are currently living in mainland China, Hong Kong, or Taiwan and are of Chinese descent.You have had a serious allergic reaction to a biologic medication in the past.I tested negative for NMDAR antibodies in my CSF within 9 months of my symptoms starting.I have not had treatments like IL-6 inhibitors, alemtuzumab, total body irradiation, or bone marrow transplantation.I have been diagnosed with progressive multifocal leukoencephalopathy.I am currently taking more than one immune system therapy.My cancer is linked to a specific immune system marker.You have previously tested positive for certain antibodies related to nerve cells, except for NMDAR and LGI1.I haven't been hospitalized or needed IV treatment for an infection in the last 4 weeks.I haven't taken cyclophosphamide or any trial drugs in the last year.I have been diagnosed with paraneoplastic encephalitis.I have a confirmed disease that affects the protective covering of my nerves.You have signs of tuberculosis (TB) infection.I am scheduled for surgery during the study period.You have thought about hurting yourself in the last 6 months, or tried to hurt yourself in the last 3 years.You have had problems with drugs or alcohol in the past year.I have not had herpes brain infection in the last 6 months.I haven't had major surgery in the last 4 weeks, except for thymoma or teratoma removal.I have not received a live vaccine in the last 6 weeks.I have not donated blood, plasma, or platelets in the last 90 days.My doctors have ruled out any new cancers before starting the trial.I have an untreated teratoma or thymoma.I have a weakened immune system, including HIV.I have not had treatments like T-cell therapy or cladribine.I had cancer before but have been cancer-free for over 5 years.I have not been treated with specific immune-targeting drugs before.I cannot receive treatments like rituximab, IVIG, steroids, or IV cyclophosphamide.You have tested positive for hepatitis B or hepatitis C.I am 12 or older with a diagnosis of NMDAR encephalitis.I have a history of severe gut issues that could risk serious complications.I am 18 or older with LGI1 encephalitis.
Research Study Groups:
This trial has the following groups:- Group 1: LGI1 AIE cohort
- Group 2: NMDAR autoimmune encephalitis (AIE) Placebo cohort
- Group 3: LGI1 AIE Placebo cohort
- Group 4: NMDAR autoimmune encephalitis (AIE) cohort
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How does the LGI1 AIE cohort impact patient safety?
"The LGI1 AIE cohort has ample evidence of its efficacy, and multiple studies have demonstrated its safety; therefore, we rate it a 3 on the risk spectrum."
Answered by AI
Are there any vacant vacancies available in this medical trial?
"Affirmative, clinicaltrials.gov is hosting the details of this research which initially went public on September 27th 2022 and had its most recent update on November 8th 2022. 152 patients need to be registered at a single medical facility."
Answered by AI
How many participants have been admitted to this clinical trial thus far?
"Affirmative. According to clinicaltrials.gov, this research trial is actively recruiting and was initially posted on September 27th 2022; the posting has been recently revised as of November 8th 2022. The study requires 152 participants from 1 medical centre."
Answered by AI
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