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

Generalized Myasthenia Gravis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04963270
• Other study ID #: WN42636
• Status: Recruiting
• Phase: Phase 3
• Start date: October 19, 2021
• Est. completion date: September 19, 2024

Study information

• Verified date: April 2024
• Source: Hoffmann-La Roche
• Contact: Reference Study ID Number: GE42063 https://forpatients.roche.com
• Phone: 888-662-6728 (U.S.)
• Email: global-roche-genentech-trials[@]gene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 185
• Est. completion date: September 19, 2024
• Est. primary completion date: January 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Generalized Myasthenia Gravis
• Muscle Weakness
• Myasthenia Gravis

Intervention

Drug:
• Satralizumab
Satralizumab will be administered as a subcutaneous injection

Other:
• Placebo
Satralizumab placebo will be administered as a subcutaneous injection

Locations

Country	Name	City	State
Argentina	Hospital Italiano; Neurology	Caba
Argentina	Hospital Ramos Mejía	Caba
Argentina	Hospital Britanico	Ciudad Autonoma Bs As
Argentina	Fundación Scherbovsky; General Department	Mendoza
Argentina	INECO Neurociencias Orono	Rosario
Argentina	Centro de Investigaciones Médicas Tucuman; REUMATHOLOGY	San Miguel
Australia	Box Hill Hospital; Department of Neurology	Box Hill	Victoria
Australia	Concord Repatriation General Hospital	Concord	New South Wales
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
Brazil	Hospital das Clinicas - UNICAMP	Campinas	SP
Brazil	Instituto de Neurologia de Curitiba	Curitiba	PR
Brazil	Hospital Sao Lucas - PUCRS	Porto Alegre	RS
Brazil	Faculdade de Medicina do ABC - FMABC	Santo Andre	SP
Brazil	Hospital Sao Paulo	Sao Paulo	SP
Canada	MUCH - Montreal Neurological Institute & Hospital	Montreal	Quebec
China	Beijing Tongren Hospital	Beijing
China	Beijing Tiantan Hospital,Capital Medical University	Beijing City
China	The First Hospital of Jilin University	Changchun City
China	Hunan Children's Hospital	Changsha City
China	Xiangya Hospital Central South University	Changsha City
China	West China Hospital - Sichuan University	Chengdu City
China	The Affiliated Hospital of Guizhou Medical University	Guiyang City
China	Sir Run Run Shaw Hospital	Hangzhou City
China	The First Affiliated Hospital Of Shandong First Medical University	Jinan City
China	Children's Hospital of Fudan University	Shanghai
China	Huashan Hospital, Fudan University	Shanghai City
China	Tianjin Medical University General Hospital	Tianjin
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou City
China	Tongji Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan City
China	Tangdu Hospital	Xi'an City
Denmark	Aarhus Universitetshospital; Neurologisk Klinik	Aarhus N
Denmark	Rigshospitalet; Klinik for Nerve- og Muskelsygdomme	København Ø
France	APHP Raymond Poincare	Garches
France	Hopital Timone Adultes; Neurologie Mal Neuro Musculaires	Marseille
France	CHU de Nantes - Hotel Dieu	Nantes
France	CHU Nice - Hôpital Pasteur 2; SYST NERVEUX PERIPHERIQUE MUSCLE	Nice
France	Hopital de la Pitie Salpetriere	Paris
France	CHU Bordeaux	Pessac
Germany	St. Josef-Hospital, Klinik für Neurologie	Bochum
Germany	Universitätsklinikum Essen (AöR); Klinik für Neurologie	Essen
Germany	Univeristätsklinikum Leipzig; Klinik und Poliklinik für Neurologie	Leipzig
Germany	Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie	Münster
Italy	Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari	Milano	Lombardia
Italy	Azienda Ospedaliera A. Cardarelli; Dipartimento medico polispecialistico	Napoli	Campania
Italy	A.R.N.A.S. Civico Di Cristina Benfratelli; U.O.C. Neurologia con Stroke Unit	Palermo	Sicilia
Italy	Fondazione Istituto Neurologico Mondino IRCCS; SC Neuroncologia e neuroinfiammazione	Pavia	Lombardia
Italy	A.O. Sant'Andrea; UOC Neurologia, Dip. di Neuroscienze, Salute Mentale e Organi di Senso (NESMOS)	Roma	Lazio
Italy	Ospedale Cà Foncello; S.C Neurologia	Treviso	Veneto
Japan	Juntendo University Hospital; Neurology	Bunkyo-ku
Japan	Chiba University Hospital; Neurology	Chiba-shi, Chiba
Japan	General Hanamaki Hospital; Neurology	Hanamaki, Iwate
Japan	Hiroshima University Hospital	Hiroshima
Japan	NHO Hokkaido Medical Center	Hokkaido
Japan	Sapporo Medical University Hospital; Neurology	Hokkaido
Japan	Kagawa University Hospital; Neurology	Kagawa
Japan	St. Marianna University Hospital	Kanagawa
Japan	Saitama Medical Center; Neurology	Kawagoe-shi, Saitama
Japan	Nagasaki Kawatana Medical Center; Neurology	Nagasaki
Japan	International University of Health and Welfare Narita Hospital; Neurology	Narita, Chiba
Japan	Kindai University Hospital; Neurology	Osaka
Japan	Osaka Toneyama Medical Center; Neurology	Osaka
Japan	Dokkyo Medical University Saitama Medical Center; Neurology	Saitama
Japan	Tokyo Women's Medical University Hospital; Neurology	Shinjuku-ku
Japan	Seirei Hamamatsu General Hospital	Shizuoka
Japan	Osaka University Hospital; Neurology	Suita
Japan	Tokyo Medical And Dental University, Medical Hospital; Neurology	Tokyo
Japan	Tokyo Medical University Hospital	Tokyo
Korea, Republic of	Kyungpook National University Chilgok Hospital	Daegu
Korea, Republic of	Pusan National University Yangsan Hospital	Gyeongsangnam-do
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Netherlands	Amsterdam UMC Location AMC	Amsterdam
Netherlands	LUMC	Leiden
Poland	Klinika Neurologii Doros?ych, Uniwersyteckie Centrum Kliniczne	Gda?sk
Poland	Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K	Krakow
Poland	Zespol Poradni Specjalistycznych - Poradnia Neurologiczna; Szpital Uniwersytecki w Krakowie	Kraków
Poland	Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.	Lublin
Russian Federation	FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency	Krasnoyarsk	Krasnojarsk
Russian Federation	Krasnoyarsk State Medical Academy	Krasnoyarsk	Krasnojarsk
Russian Federation	Research Center of Neurology; Neurology Department #5	Moskva	Moskovskaja Oblast
Russian Federation	Novosibirsk State Regional Clinical Hospital	Novosibirsk
Russian Federation	Samara Regional Clinical Hospital named after V.D. Seredavina	Samara
Russian Federation	National Center of Social Significant Disease	Sankt-peterburg	Leningrad
Russian Federation	Leningrad Regional Clinical Hospital	St Petersburg	Sankt Petersburg
Spain	Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia	Barcelona
Spain	Hospital Universitari de Bellvitge; Servicio de Neurologia	L'Hospitalet de Llobregat	Barcelona
Spain	Clinica Universitaria Navarra; Servicio Neurologia	Madrid
Spain	Hospital General Universitario Gregorio Marañon; Servicio de Neurologia	Madrid
Spain	Clinica Universitaria de Navarra; Servicio de Neurología	Pamplona	Navarra
Spain	Hospital de Donostia Unidad Demencias; Consultas de Neurología	San Sebastian	Guipuzcoa
Spain	Hospital Universitario Infanta Sofia; Servicio de Neurologia	San Sebastian de los Reyes	Madrid
Spain	Hospital Universitario la Fe; Servicio de Neurologia	Valencia
Taiwan	Taipei Veterans General Hospital-Neurology	Taipei
Taiwan	Chang Gung Medical Foundation Linkou Branch	Taoyuan City
Turkey	Hacettepe University Medical Faculty; Neurology	Ankara
Turkey	Ege University Medical Faculty	Izmir
Turkey	Kocaeli University Hospital; Department of Neurology	Kocaeli
Turkey	Ondokuz Mayis Univ. Med. Fac.; Neurology	Samsun
Turkey	Karadeniz Tecnical Uni. Med. Fac.; Neurology	Trabzon
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University at Buffalo / SUNY; UBMD Neurology	Buffalo	New York
United States	NeuroScience Research Center	Canton	Ohio
United States	University of Chicago Hospital	Chicago	Illinois
United States	The Ohio State University Wexner Medical Center; Department of Neurology	Columbus	Ohio
United States	University of Iowa Hospitals & Clinics; Department of Neurology	Iowa City	Iowa
United States	University of Florida Jacksonville Physicians Inc. (UFJPI)	Jacksonville	Florida
United States	Keck School of Medicine of USC	Los Angeles	California
United States	Prairie Education and Research	O'Fallon	Illinois
United States	University of California Irvine - Manchester Pavilion	Orange	California
United States	SC3 Research Group, Inc	Pasadena	California
United States	South Shore Neurologic Associates P.C.	Patchogue	New York
United States	Washington University School of Medicine; Department of Neurology	Saint Louis	Missouri
United States	UCSF Benioff Children's Hospital; Department of Pediatrics	San Francisco	California
United States	HonorHealth Neurology	Scottsdale	Arizona
United States	Childrens National Health Center	Washington	District of Columbia
United States	Medical Faculty Associates Inc.	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Hoffmann-La Roche	Chugai Pharmaceutical

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Canada,  China,  Denmark,  France,  Germany,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Poland,  Russian Federation,  Spain,  Taiwan,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score in AChR-antibody seropositive population		Week 24
Secondary	Mean change from baseline in Quantitative Myasthenia Gravis (QMG) score		Week 24
Secondary	Mean change from baseline in Myasthenia Gravis Quality of Life 15 Scale (MG-QOL 15r) score		Week 24
Secondary	Mean change from baseline in Quality of Life in Neurological Disorders (Neuro-QoL) Fatigue Subscale score		Week 24
Secondary	Mean change from baseline in total Myasthenia Gravis Composite (MGC) score		Week 24
Secondary	Proportion of MG-ADL responders		Week 24
Secondary	Proportion of QMG responder		Week 24
Secondary	Proportion of MGC responders		Week 24
Secondary	Proportion of participants who have achieved minimal disease manifestation (total MG-ADL score of 0 or 1)		Week 24