LGI1 AIE cohort for LGI1 Autoimmune Encephalitis

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
University of Alabama at Birmingham, Birmingham, ALLGI1 Autoimmune Encephalitis+1 MoreSatralizumab - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

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

2 of 3
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

3 of 3
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
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT02028884) in the Satralizumab + Baseline Treatment, DB Period ARM group. Side effects include: Upper respiratory tract infection with 24%, Nasopharyngitis with 24%, Headache with 24%, Urinary tract infection with 15%, Leukopenia with 15%.

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: Drug
NMDAR autoimmune encephalitis (AIE) cohort
Drug
Experimental Group · 1 Intervention: Satralizumab · Intervention Types: Drug
NMDAR autoimmune encephalitis (AIE) Placebo cohort
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
LGI1 AIE Placebo cohort
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
Treatment
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
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.