A Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis

This study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of satralizumab compared with placebo in participants with generalized myasthenia gravis (gMG).

Study Overview

• Status: Terminated
• Conditions: Generalized Myasthenia Gravis
• Intervention / Treatment: Drug: Satralizumab; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 188
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Caba, Argentina, C1221ADC
    • Hospital Ramos Mejía
  • Caba, Argentina, C1199ABA
    • Hospital Italiano
  • Ciudad Autonoma Bs As, Argentina, C1280AEB
    • Hospital Britanico
  • Mendoza, Argentina, M5500AYB
    • Fundacion Scherbovsky
  • Rosario, Argentina, S2000DTC
    • INECO Neurociencias Orono
• Australia
  • New South Wales
    • Concord, New South Wales, Australia, 2139
      • Concord Repatriation General Hospital
• Brazil
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
      • Hospital Sao Lucas - PUCRS
  • São Paulo
    • Campinas, São Paulo, Brazil, 13083-887
      • Hospital das Clinicas - UNICAMP
    • Santo Andre, São Paulo, Brazil, 09060-650
      • Faculdade de Medicina do ABC - FMABC
    • Sao Paulo, São Paulo, Brazil, 04037-002
      • Hospital Sao Paulo
• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3A 2B4
      • MUCH - Montreal Neurological Institute & Hospital
• China
  • Beijing, China, 100730
    • Beijing Tongren Hospital
  • Beijing, China, DUMMY_VALUE
    • Beijing Tiantan Hospital,Capital Medical University
  • Changchun City, China, 130021
    • The First Hospital of Jilin University
  • Chengdu City, China, 610047
    • West China Hospital - Sichuan University
  • Guiyang, China, DUMMY_VALUE
    • The Affiliated Hospital of Guizhou Medical University
  • Hangzhou, China, 310016
    • Sir Run Run Shaw Hospital
  • Jinan, China, DUMMY_VALUE
    • The First Affiliated Hospital of Shandong First Medical University
  • Shanghai, China, 201102
    • Children's Hospital of Fudan University
  • Shanghai City, China, 200040
    • Huashan Hospital, Fudan University
  • Tianjin, China, 300052
    • Tianjin Medical University General Hospital
  • Wuhan City, China, 430030
    • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
  • Xi'an City, China, 710038
    • Tangdu Hospital
• Denmark
  • Aarhus N, Denmark, 8200
    • Aarhus Universitetshospital
  • København Ø, Denmark, 2100
    • Rigshospitalet
• France
  • Bordeaux cedex, France, 33076
    • CHU Bordeaux
  • Garches, France, 92380
    • APHP Raymond Poincare
  • Marseille, France, 13385
    • Hopital Timone Adultes
  • Nantes, France, 44093
    • CHU de Nantes - Hotel Dieu
  • Nice, France, 06000
    • CHU Nice - Hôpital Pasteur 2
• Germany
  • Bochum, Germany, 44791
    • St. Josef-Hospital, Klinik für Neurologie
  • Essen, Germany, 45147
    • Universitatsklinikum Essen (Aor)
  • Münster, Germany, 48149
    • Universitätsklinikum Münster
• Italy
  • Campania
    • Napoli, Campania, Italy, 80131
      • Azienda Ospedaliera A. Cardarelli
  • Lombardia
    • Milano, Lombardia, Italy, 20133
      • Fond. Istituto Neurologico C.Besta
  • Sicilia
    • Palermo, Sicilia, Italy, 90127
      • A.R.N.A.S. Civico Di Cristina Benfratelli
  • Veneto
    • Treviso, Veneto, Italy, 31100
      • Ospedale Ca Foncello
• Japan
  • Bunkyo-ku, Japan, 113-8431
    • Juntendo University Hospital
  • Chiba-shi, Chiba, Japan, 260-8677
    • Chiba University Hospital
  • Hanamaki, Iwate, Japan, 025-0082
    • General Hanamaki Hospital
  • Hokkaido, Japan, 060-8543
    • Sapporo Medical University Hospital
  • Hokkaido, Japan, 063-0005
    • NHO Hokkaido Medical Center
  • Kanagawa, Japan, 216-8511
    • St. Marianna University Hospital
  • Narita, Chiba, Japan, 286-0124
    • International University of Health and Welfare Narita Hospital
  • Osaka, Japan, 589-8511
    • Kindai University Hospital
  • Shizuoka, Japan, 430-8558
    • Seirei Hamamatsu General Hospital
  • Suita, Japan, 565-0871
    • Osaka University Hospital
  • Tokyo, Japan, 160-0023
    • Tokyo Medical University Hospital
  • Tokyo, Japan, 113-8519
    • Tokyo Medical and Dental University, Medical Hospital
• Korea, Republic of
  • Daegu, Korea, Republic of, 41404
    • Kyungpook National University Chilgok Hospital
  • Gyeongsangnam-do, Korea, Republic of, 50612
    • Pusan National University Yangsan Hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 02841
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of, (0)6351
    • Samsung Medical Center
• Poland
  • Gda?sk, Poland, 80-952
    • Klinika Neurologii Doros?ych, Uniwersyteckie Centrum Kliniczne
  • Krakow, Poland, 31-505
    • Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K
  • Kraków, Poland, 31-503
    • Zespol Poradni Specjalistycznych - Poradnia Neurologiczna
  • Lublin, Poland, 20-016
    • Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.
• Russian Federation
  • Novosibirsk, Russian Federation, 630087
    • Novosibirsk State Regional Clinical Hospital
  • Krasnojarsk
    • Krasnoyarsk, Krasnojarsk, Russian Federation, 660022
      • Krasnoyarsk State Medical Academy
• Spain
  • Barcelona, Spain, 08025
    • Hospital de la Santa Creu i Sant Pau
  • Valencia, Spain, 46026
    • Hospital Universitario la Fe
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Hospital Universitari de Bellvitge
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Clinica Universitaria de Navarra
• Taiwan
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital-Neurology
  • Taoyuan City, Taiwan, 333
    • Chang Gung Medical Foundation Linkou Branch
• Turkey
  • Ankara, Turkey, 06100
    • Hacettepe University Medical Faculty
  • Izmir, Turkey, 35100
    • Ege University Medical Faculty
  • Kocaeli, Turkey, 41380
    • Kocaeli University Hospital
  • Samsun, Turkey, 55139
    • Ondokuz Mayis Univ. Med. Fac.
• United States
  • California
    • Los Angeles, California, United States, 90033
      • Keck School of Medicine of USC
    • Orange, California, United States, 92868
      • University of California Irvine - Manchester Pavilion
    • Pasadena, California, United States, 91105
      • SC3 Research Group, Inc
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • Medical Faculty Associates Inc.
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Hospital
    • O'Fallon, Illinois, United States, 62269
      • Prairie Education and Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Signed Informed Consent Form
• For adolescent patients: Informed Consent Form for study participation signed by the parents or a legal guardian, and patient assent obtained, as per local requirements
• Ability to comply with the study protocol procedures
• Confirmed diagnosis of gMG (anti-AChR, anti-MuSK or anti-LRP4 present at screening)
• A total MG-ADL score of ≥ 5 points at screening with more than 50% of this score attributed to non-ocular items
• MGFA severity Class II-IV
• Ongoing gMG treatment at a stable dose
• For female patients of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for at least 3 months after the final dose of satralizumab.

Exclusion Criteria:

• History of thymectomy within 12 months prior to screening
• Ocular MG (MGFA Class I) and myasthenic crisis (MGFA Class V) within the last 3 months prior to screening
• Known disease other than gMG that would interfere with the course and conduct of the study
• Positive screening tests for hepatitis B virus (HBV) and hepatitis C virus (HCV)
• Evidence of latent or active tuberculosis (excluding patients receiving chemoprophylaxis for latent tuberculosis infection)
• Receipt of live or live attenuated vaccine within 6 weeks prior to baseline
• Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the last dose

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants will receive placebo at Weeks 0, 2, 4, and Q4W thereafter	Other: Placebo; Satralizumab placebo will be administered as a subcutaneous injection
Experimental: Satralizumab; Participants will receive Satralizumab at Weeks 0, 2, 4, and Q4W thereafter. Adolescent patients who first enter the study in the OLE period will receive satralizumab SC loading doses at Week 0, 2, and 4 in the OLE, followed by maintenance doses Q4W thereafter and will remain on stable background therapy until Week 24 of the OLE.	Drug: Satralizumab; Satralizumab will be administered as a subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DB Period: Mean Change From Baseline in Total Myasthenia Gravis Activities of Daily Living (MG-ADL) Score in the AChR+ Population	The MG-ADL scale was used to assess the degree of gMG symptoms (six items: diplopia, ptosis, difficulties with chewing, swallowing, talking, and respiratory problems) and functional limitations in carrying out activities of daily living (two items: ability to brush teeth or comb hair and impairment in the ability to arise from a chair) that are present and clinically relevant in gMG participants. Each of the eight items was ranked on a 0-3 scale, with 3 representing the most severe symptoms or impaired performance and 0 representing no symptoms or impaired performance. The total MG-ADL score was calculated as the sum of each item score, with a maximum score ranging from 0 (least severe symptoms/impairment) to 24 (most severe symptoms/impairment). Higher scores indicate greater disease severity.	At Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DB Period: Mean Change From Baseline in Total MG-ADL Score in the Overall Population (OP) at Week 24	The MG-ADL scale was used to assess the degree of gMG symptoms (six items: diplopia, ptosis, difficulties with chewing, swallowing, talking, and respiratory problems) and functional limitations in carrying out activities of daily living (two items: ability to brush teeth or comb hair and impairment in the ability to arise from a chair) that are present and clinically relevant in gMG participants. Each of the eight items was ranked on a 0-3 scale, with 3 representing the most severe symptoms or impaired performance and 0 representing no symptoms or impaired performance. The total MG-ADL score was calculated as the sum of each item score, with a maximum score ranging from 0 (least severe symptoms/impairment) to 24 (most severe symptoms/impairment). Higher scores indicate greater disease severity.	At Week 24
DB Period: Percentage of Participants With a ≥ 2-point Reduction From Baseline in Total MG-ADL Score in AChR+ Population at Week 24	The MG-ADL scale was used to assess the degree of gMG symptoms (six items: diplopia, ptosis, difficulties with chewing, swallowing, talking, and respiratory problems) and functional limitations in carrying out activities of daily living (two items: ability to brush teeth or comb hair and impairment in the ability to arise from a chair) that are present and clinically relevant in gMG participants. Each of the eight items was ranked on a 0-3 scale, with 3 representing the most severe symptoms or impaired performance and 0 representing no symptoms or impaired performance. The total MG-ADL score was calculated as the sum of each item score, with a maximum score ranging from 0 (least severe symptoms/impairment) to 24 (most severe symptoms/impairment). Higher scores indicate greater disease severity. Participants who received rescue therapy were considered non-responders.	At Week 24
DB Period: Percentage of Participants With a ≥ 2-point Reduction From Baseline in Total MG-ADL Score in OP at Week 24	The MG-ADL scale was used to assess the degree of gMG symptoms (six items: diplopia, ptosis, difficulties with chewing, swallowing, talking, and respiratory problems) and functional limitations in carrying out activities of daily living (two items: ability to brush teeth or comb hair and impairment in the ability to arise from a chair) that are present and clinically relevant in gMG participants. Each of the eight items was ranked on a 0-3 scale, with 3 representing the most severe symptoms or impaired performance and 0 representing no symptoms or impaired performance. The total MG-ADL score was calculated as the sum of each item score, with a maximum score ranging from 0 (least severe symptoms/impairment) to 24 (most severe symptoms/impairment). Higher scores indicate greater disease severity. Participants who received rescue therapy were considered non-responders.	At Week 24
DB Period: Mean Change From Baseline in Quantitative Myasthenia Gravis (QMG) Score in AChR+ Population at Week 24	The QMG is a 13-item direct physician assessment scoring system that quantifies disease severity based on impairments of body functions and structures. The 13-items are: ptosis, diplopia, orbicularis oculi weakness, swallowing, speech disruption, percent forced vital capacity, arm and leg endurance (four items), grip strength (two items), and neck flexion strength. Each of the 13 item was quantitatively assessed and scored on a scale from 0=None to 3=Severe, providing a total QMG score (sum of each item score) ranging from 0 to 39 where higher scores indicate greater disease severity.	At Week 24
DB Period: Mean Change From Baseline in QMG Score in OP at Week 24	The QMG is a 13-item direct physician assessment scoring system that quantifies disease severity based on impairments of body functions and structures. The 13-items are: ptosis, diplopia, orbicularis oculi weakness, swallowing, speech disruption, percent forced vital capacity, arm and leg endurance (four items), grip strength (two items), and neck flexion strength. Each of the 13 item was quantitatively assessed and scored on a scale from 0=None to 3=Severe, providing a total QMG score (sum of each item score) ranging from 0 to 39 where higher scores indicate greater disease severity.	At Week 24
DB Period: Mean Change From Baseline in Myasthenia Gravis Quality of Life 15 Scale (Revised) (MG-QOL 15r) Total Score in AChR+ Population at Week 24	The MG-QOL-15r is a disease-specific health-related QoL measure that consists of 15 items: mobility (9 items), symptoms (3 items), and contentment and emotional well-being (3 items). Items were scored on a scale from 0=Not at all to 2=Very much with the total score ranging from 0 to 30 and higher scores indicate worse health-related quality of life (HRQoL).	At Week 24
DB Period: Mean Change From Baseline in MG-QOL 15r Total Score in OP at Week 24	The MG-QOL-15r is a disease-specific health-related QoL measure that consists of 15 items: mobility (9 items), symptoms (3 items), and contentment and emotional well-being (3 items). Items are scored on a scale from 0=Not at all to 2=Very much, with the total score ranging from 0 to 30 and higher scores indicate worse HRQoL.	At Week 24
DB Period: Mean Change From Baseline in Quality of Life in Neurological Disorders (Neuro-QoL) Fatigue Subscale Total Score in AChR+ Population at Week 24	The Neuro-QoL is a validated tool designed to evaluate the HRQoL in participants with chronic neurological disease. The Fatigue Subscale is implemented as an eight-item, stand-alone short form that assesses the multi-dimensional aspects of fatigue ranging from general tiredness to debilitating exhaustion that Impacts activities of daily living. Each item was assessed using a 5-level Likert scale ranging between 1=never to 5=always. Raw scores range from 8 to 40, higher values indicate greater fatigue.	At Week 24
DB Period: Mean Change From Baseline in Neuro-QoL Fatigue Subscale Total Score in OP at Week 24	The Neuro-QoL is a validated tool designed to evaluate the HRQoL in participants with chronic neurological disease. The Fatigue Subscale is implemented as an eight-item, stand-alone short form that assesses the multi-dimensional aspects of fatigue ranging from general tiredness to debilitating exhaustion that Impacts activities of daily living. Each item was assessed using a 5-level Likert scale ranging between 1=never to 5=always. Raw scores range from 8 to 40, higher values indicate greater fatigue.	At Week 24
DB Period: Percentage of Participants With a ≥ 3-point Reduction From Baseline in QMG Score in AChR+ Population at Week 24	The QMG is a 13-item direct physician assessment scoring system that quantifies disease severity based on impairments of body functions and structures. The 13-items are: ptosis, diplopia, orbicularis oculi weakness, swallowing, speech disruption, percent forced vital capacity, arm and leg endurance (four items), grip strength (two items), and neck flexion strength. Each of the 13 item was quantitatively assessed and scored on a scale from 0=None to 3=Severe, providing a total QMG score (sum of each item score) ranging from 0 to 39 where higher scores indicate greater disease severity.	At Week 24
DB Period: Percentage of Participants With a ≥ 3-point Reduction From Baseline in QMG Score in OP at Week 24	The QMG is a 13-item direct physician assessment scoring system that quantifies disease severity based on impairments of body functions and structures. The 13-items are: ptosis, diplopia, orbicularis oculi weakness, swallowing, speech disruption, percent forced vital capacity, arm and leg endurance (four items), grip strength (two items), and neck flexion strength. Each of the 13 item was quantitatively assessed and scored on a scale from 0=None to 3=Severe, providing a total QMG score (sum of each item score) ranging from 0 to 39 where higher scores indicate greater disease severity.	At Week 24
DB Period: Mean Change From Baseline in Total Myasthenia Gravis Composite (MGC) Score in AChR+ Population at Week 24	The MGC is a composite measure consisting of items drawn from the MG-ADL (chewing, swallowing, speech, and breathing), QMG (diplopia and ptosis), and Manual Muscle Test (hip flexion strength, neck, facial, and shoulder abduction) in an effort to include both clinician- and participant-reported elements in a single measure. Each of the ten items contribute to a total score ranging from 0 to 50, with higher values indicating greater disease severity.	At Week 24
DB Period: Mean Change From Baseline in Total MGC Score in OP at Week 24	The MGC is a composite measure consisting of items drawn from the MG-ADL (chewing, swallowing, speech, and breathing), QMG (diplopia and ptosis), and Manual Muscle Test (hip flexion strength, neck, facial, and shoulder abduction) in an effort to include both clinician- and participant-reported elements in a single measure. Each of the ten items contribute to a total score ranging from 0 to 50, with higher values indicating greater disease severity.	At Week 24
DB Period: Percentage of Participants With a ≥ 3-point Reduction From Baseline in Total MGC Score in AChR+ Population at Week 24	The MGC is a composite measure consisting of items drawn from the MG-ADL (chewing, swallowing, speech, and breathing), QMG (diplopia and ptosis), and Manual Muscle Test (hip flexion strength, neck, facial, and shoulder abduction) in an effort to include both clinician- and participant-reported elements in a single measure. Each of the ten items contribute to a total score ranging from 0 to 50, with higher values indicating greater disease severity.	At Week 24
DB Period: Percentage of Participants With a ≥ 3-point Reduction From Baseline in Total MGC Score in OP at Week 24	The MGC is a composite measure consisting of items drawn from the MG-ADL (chewing, swallowing, speech, and breathing), QMG (diplopia and ptosis), and Manual Muscle Test (hip flexion strength, neck, facial, and shoulder abduction) in an effort to include both clinician- and participant-reported elements in a single measure. Each of the ten items contribute to a total score ranging from 0 to 50, with higher values indicating greater disease severity.	At Week 24
DB Period: Percentage of Participants Who Achieved Minimal Symptom Expression (Total MG-ADL Score of 0 or 1) in AChR+ Population at Week 24	The MG-ADL scale was used to assess the degree of gMG symptoms (six items: diplopia, ptosis, difficulties with chewing, swallowing, talking, and respiratory problems) and functional limitations in carrying out activities of daily living (two items: ability to brush teeth or comb hair and impairment in the ability to arise from a chair) that are present and clinically relevant in gMG participants. Each of the eight items was ranked on a 0-3 scale, with 3 representing the most severe symptoms or impaired performance and 0 representing no symptoms or impaired performance. The total MG-ADL score was calculated as the sum of each item score, with a maximum score ranging from 0 (least severe symptoms/impairment) to 24 (most severe symptoms/impairment). Higher scores indicate greater disease severity.	At Week 24
DB Period: Percentage of Participants Who Achieved Minimal Symptom Expression (Total MG-ADL Score of 0 or 1) in OP at Week 24	The MG-ADL scale was used to assess the degree of gMG symptoms (six items: diplopia, ptosis, difficulties with chewing, swallowing, talking, and respiratory problems) and functional limitations in carrying out activities of daily living (two items: ability to brush teeth or comb hair and impairment in the ability to arise from a chair) that are present and clinically relevant in gMG participants. Each of the eight items was ranked on a 0-3 scale, with 3 representing the most severe symptoms or impaired performance and 0 representing no symptoms or impaired performance. The total MG-ADL score was calculated as the sum of each item score, with a maximum score ranging from 0 (least severe symptoms/impairment) to 24 (most severe symptoms/impairment). Higher scores indicate greater disease severity.	At Week 24
DB Period: Percentage of Participants With at Least One gMG-Related Exacerbation Between Baseline and Week 24 in AChR+ Population	gMG-related exacerbation was defined as one of the following: MG crisis; Substantial symptomatic worsening that requires immediate therapy; or health in jeopardy if rescue therapy is not given.	Baseline up to Week 24
DB Period: Percentage of Participants With at Least One gMG-Related Exacerbation Between Baseline and Week 24 in OP	gMG-related exacerbation was defined as one of the following: MG crisis; Substantial symptomatic worsening that requires immediate therapy; or health in jeopardy if rescue therapy is not given.	Baseline up to Week 24
DB Period: Percentage of Participants in AChR+ Population Receiving Rescue Therapy Between Baseline and Week 24	The percentage of participants receiving rescue therapy during DBP analyzed the variable that encodes whether a participant received rescue therapy during DBP or not. If a participant stopped the study drug but received rescue therapy during the safety follow-up and this occurred within 24 weeks of baseline then this was counted as having received rescue therapy.	Baseline up to Week 24
DB Period: Percentage of Participants in OP Receiving Rescue Therapy Between Baseline and Week 24	The percentage of participants receiving rescue therapy during DBP analyzed the variable that encodes whether a participant received rescue therapy during DBP or not. If a participant stopped the study drug but received rescue therapy during the safety follow-up and this occurred within 24 weeks of baseline then this was counted as having received rescue therapy.	Baseline up to Week 24
DB Period: Duration of Meaningful Improvement, Defined as ≥ 2-Point Reduction From Baseline in Total MG-ADL Score in AChR+ Population	The duration was the difference in weeks between the two visits defining the start and end (or Week 24) of reduction from baseline. The MG-ADL scale was used to assess the degree of gMG symptoms (six items: diplopia, ptosis, difficulties with chewing, swallowing, talking, and respiratory problems) and functional limitations in carrying out activities of daily living (two items: ability to brush teeth or comb hair and impairment in the ability to arise from a chair) that are present and clinically relevant in gMG participants. Each of the eight items was ranked on a 0-3 scale, with 3 representing the most severe symptoms or impaired performance and 0 representing no symptoms or impaired performance. The total MG-ADL score was calculated as the sum of each item score, with a maximum score ranging from 0 (least severe symptoms/impairment) to 24 (most severe symptoms/impairment). Higher scores indicate greater disease severity.	Baseline, Week 24
DB Period: Duration of Meaningful Improvement, Defined as ≥ 2-Point Reduction From Baseline in Total MG-ADL Score in OP	The duration was the difference in weeks between the two visits defining the start and end (or Week 24) of reduction from baseline. The MG-ADL scale was used to assess the degree of gMG symptoms (six items: diplopia, ptosis, difficulties with chewing, swallowing, talking, and respiratory problems) and functional limitations in carrying out activities of daily living (two items: ability to brush teeth or comb hair and impairment in the ability to arise from a chair) that are present and clinically relevant in gMG participants. Each of the eight items was ranked on a 0-3 scale, with 3 representing the most severe symptoms or impaired performance and 0 representing no symptoms or impaired performance. The total MG-ADL score was calculated as the sum of each item score, with a maximum score ranging from 0 (least severe symptoms/impairment) to 24 (most severe symptoms/impairment). Higher scores indicate greater disease severity.	Baseline, Week 24
DB Period: Number of Participants With Adverse Events (AEs)	An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptoms, or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product.	Day 1 up to approximately 24 weeks
DB Period: Serum Levels of Interleukin-6 (IL-6)		Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24
DB Period: Serum Levels of Soluble Interleukin-6 Receptors (sIL-6R)		Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24
Number of Participants With Anti-drug Antibodies (ADAs) to Satralizumab	The percentage of ADA-positive participants after drug administration were determined for participants exposed to satralizumab. For determining post-baseline incidence, participants were considered to be ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following study drug exposure, or if they were ADA-positive at baseline and the titer of 1 or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the baseline titer result. Participants were considered to be ADA-negative if they were ADA-negative or had missing data at baseline and all post-baseline samples were negative, or if they were ADA positive at baseline but did not have any post-baseline samples with a titer that is at least 4-fold (0.60 titer unit) greater than the titer of the baseline sample.	Baseline to Week 24
Serum Concentrations of Satralizumab		Weeks 0, 2, 4, 8, 12, 16, 20 and 24

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Collaborators: Chugai Pharmaceutical
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2021
• Primary Completion (Actual): January 29, 2024
• Study Completion (Actual): September 2, 2024

Study Registration Dates

• First Submitted: July 7, 2021
• First Submitted That Met QC Criteria: July 7, 2021
• First Posted (Actual): July 15, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 24, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Manifestations; Pathologic Processes; Neoplasms by Site; Neoplasms; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Autoimmune Diseases of the Nervous System; Neurodegenerative Diseases; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Paraneoplastic Syndromes; Neuromuscular Junction Diseases; Muscle Weakness; Myasthenia Gravis
• Other Study ID Numbers: WN42636

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No