Study Summary
This trial will test a new drug to treat two types of brain inflammation: NMDAR and LGI1 encephalitis.
Eligible Conditions
- LGI1 Autoimmune Encephalitis
- NMDA Receptor Autoimmune Encephalitis
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
2 Primary · 8 Secondary · Reporting Duration: From Week 52 up to 2 years
Week 24
Part 1: Change in CASE score from baseline at Week 24
Part 1: MOCA total score at Week 24
Part 1: Proportion of participants with mRS score improvement ≥ 1 from baseline and no use of rescue therapy at Week 24
Part 1: RAVLT score at Week 24 (LGI1 AIE cohort)
Part 1: Time to seizure freedom or cessation of status epilepticus without use of rescue therapy
Part 1: mRS score at Week 24 (as measured on a 7-point scale; NMDAR AIE cohort)
Week 52
Part 1: Time to mRS score improvement ≥ 1 from baseline without use of rescue therapy
Part 1: Time to rescue therapy
Year 2
Part 1: Percentage of participants with adverse events
Year 2
Part 2: Percentage of participants with adverse events
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Side Effects for
Satralizumab + Baseline Treatment, DB Period
24%Upper respiratory tract infection
24%Nasopharyngitis
24%Headache
15%Urinary tract infection
15%Leukopenia
10%Pharyngitis
10%Hypercholesterolaemia
10%Back pain
10%Gastritis
10%Arthralgia
7%Hypertension
7%Rhinitis
7%Sinusitis
7%Urticaria
7%Lymphopenia
7%Anaemia
7%Nausea
7%Oropharyngeal pain
7%Cystitis
5%Oral herpes
5%Dizziness
5%Spinal pain
5%Fatigue
5%Herpes zoster
5%Neutrophil count decreased
5%Compression fracture
5%Iron deficiency
5%Anxiety
5%Eczema
5%Abdominal pain
5%Neutropenia
5%Dental caries
5%Epistaxis
5%Constipation
5%Low density lipoprotein increased
5%Vertigo
5%Leukocyturia
5%Chest discomfort
5%Hyperlipidaemia
5%Iron deficiency anaemia
2%Pneumonia
2%Malaise
2%Rash pruritic
2%Spinal osteoarthritis
2%Lower limb fracture
2%Tension headache
2%Abdominal pain upper
2%Thermal burn
2%Cough
2%Protein urine present
2%Alopecia
2%Osteoarthritis
2%Hypoaesthesia
2%Suicide attempt
2%Ligament sprain
2%Dry eye
2%Retinal haemorrhage
2%Abdominal distension
2%Viral upper respiratory tract infection
2%Contusion
2%Alanine aminotransferase increased
2%Feeling hot
2%Blood alkaline phosphatase increased
2%Serum ferritin decreased
2%Urobilinogen urine increased
2%Weight decreased
2%Amenorrhoea
2%Acne
2%Neck pain
2%Dyslipidaemia
2%Dyspepsia
2%Anaemia macrocytic
2%Hypofibrinogenaemia
2%Hypertransaminasaemia
2%Periodontitis
2%Rhinorrhoea
2%Erythema
2%Musculoskeletal stiffness
2%Myopathy toxic
2%Femur fracture
2%Spinal compression fracture
2%Pain in extremity
2%Wound
2%Lymphocyte count decreased
2%White blood cell count decreased
2%Intercostal neuralgia
2%Flushing
2%Polycythaemia
2%Angina pectoris
2%Aspartate aminotransferase increased
2%Myalgia
2%Bradycardia
2%Plicated tongue
2%Chills
2%Arthropod sting
2%Onychomycosis
2%Blood creatine phosphokinase increased
2%Large intestine polyp
2%Excoriation
2%Depression
2%Cervical dysplasia
2%Cataract
2%Weight increased
2%Oedema peripheral
2%Conjunctival haemorrhage
2%Diarrhoea
2%Insomnia
Trial Design
4 Treatment Groups
LGI1 AIE cohort
1 of 4
NMDAR autoimmune encephalitis (AIE) cohort
1 of 4
NMDAR autoimmune encephalitis (AIE) Placebo cohort
1 of 4
LGI1 AIE Placebo cohort
1 of 4
Experimental Treatment
Non-Treatment Group
152 Total Participants · 4 Treatment Groups
Primary Treatment: LGI1 AIE cohort · Has Placebo Group · Phase 3
LGI1 AIE cohort
Drug
Experimental Group · 1 Intervention: Satralizumab · Intervention Types: DrugNMDAR autoimmune encephalitis (AIE) cohort
Drug
Experimental Group · 1 Intervention: Satralizumab · Intervention Types: DrugNMDAR autoimmune encephalitis (AIE) Placebo cohort
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: OtherLGI1 AIE Placebo cohort
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: OtherTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Satralizumab
2014
Completed Phase 3
~180
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from week 52 up to 2 years
Who is running the clinical trial?
Chugai Pharmaceutical Co.UNKNOWN
2 Previous Clinical Trials
180 Total Patients Enrolled
Hoffmann-La RocheLead Sponsor
2,371 Previous Clinical Trials
1,068,485 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,152 Previous Clinical Trials
876,102 Total Patients Enrolled
Eligibility Criteria
Age Any Age · All Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have recently developed or not fully responded to an immune-related adverse event (AIE) as defined by the study.
Frequently Asked Questions
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." - Anonymous Online Contributor
Unverified Answer
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." - Anonymous Online Contributor
Unverified Answer
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." - Anonymous Online Contributor
Unverified Answer