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

Sponsor

Hoffmann-La Roche (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04963270

Collaborator

(none)

240

Enrollment

Locations

Arms

50.4

Anticipated Duration (Months)

2.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Generalized Myasthenia Gravis	Drug: Satralizumab Other: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Oct 19, 2021

Anticipated Primary Completion Date :

Jul 14, 2023

Anticipated Study Completion Date :

Dec 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Satralizumab Participants will receive Satralizumab at Weeks 0, 2, 4, and Q4W thereafter	Drug: Satralizumab Satralizumab will be administered as a subcutaneous injection
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

Arm

Intervention/Treatment

Experimental: Satralizumab

Participants will receive Satralizumab at Weeks 0, 2, 4, and Q4W thereafter

Drug: Satralizumab

Satralizumab will be administered as a subcutaneous injection

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

Outcome Measures

Primary Outcome Measures

Mean change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score in AChR-antibody seropositive population [Week 24]

Secondary Outcome Measures

Mean change from baseline in Quantitative Myasthenia Gravis (QMG) score [Week 24]
Mean change from baseline in Myasthenia Gravis Quality of Life 15 Scale (MG-QOL 15r) score [Week 24]
Mean change from baseline in Quality of Life in Neurological Disorders (Neuro-QoL) Fatigue Subscale score [Week 24]
Mean change from baseline in total Myasthenia Gravis Composite (MGC) score [Week 24]
Proportion of MG-ADL responders [Week 24]
Proportion of QMG responder [Week 24]
Proportion of MGC responders [Week 24]
Proportion of participants who have achieved minimal disease manifestation (total MG-ADL score of 0 or 1) [Week 24]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	HonorHealth Neurology	Scottsdale	Arizona	United States	85251
2	Keck School of Medicine of USC	Los Angeles	California	United States	90033
3	University of California Irvine - Manchester Pavilion	Orange	California	United States	92868
4	Medical Faculty Associates Inc.	Washington	District of Columbia	United States	20037
5	University of Florida Jacksonville Physicians Inc. (UFJPI)	Jacksonville	Florida	United States	32209
6	University of Chicago Hospital	Chicago	Illinois	United States	60637
7	University of Iowa Hospitals & Clinics; Department of Neurology	Iowa City	Iowa	United States	52242
8	Massachusetts General Hospital	Boston	Massachusetts	United States	02114-2621
9	Washington University School of Medicine; Department of Neurology	Saint Louis	Missouri	United States	63110
10	NeuroScience Research Center	Canton	Ohio	United States	44718
11	Hospital Italiano; Neurology	Caba		Argentina	C1199ABA
12	Hospital Ramos Mejía	Caba		Argentina	C1221ADC
13	Hospital Britanico	Ciudad Autonoma Bs As		Argentina	C1280AEB
14	Centro de Investigaciones Médicas Tucuman; REUMATHOLOGY	San Miguel		Argentina	T4000AXL
15	Concord Repatriation General Hospital	Concord	New South Wales	Australia	2139
16	Princess Alexandra Hospital	Woolloongabba	Queensland	Australia	4102
17	Box Hill Hospital; Department of Neurology	Box Hill	Victoria	Australia	3128
18	Faculdade de Medicina do ABC - FMABC	Santo Andre	SP	Brazil	09060-650
19	MUCH - Montreal Neurological Institute & Hospital	Montreal	Quebec	Canada	H3A 2B4
20	Beijing Tongren Hospital	Beijing		China	100730
21	The First Hospital of Jilin University	Changchun City		China	130021
22	Hunan Children's Hospital	Changsha City		China	410007
23	Xiangya Hospital Central South University	Changsha City		China	410008
24	West China Hospital - Sichuan University	Chengdu City		China	610047
25	The Affiliated Hospital of Guizhou Medical University	Guiyang City		China	550000
26	Sir Run Run Shaw Hospital	Hangzhou		China	310016
27	The First Affiliated Hospital Of Shandong First Medical University	Jinan City		China	250014
28	Huashan Hospital, Fudan University	Shanghai City		China	200040
29	Tianjin Medical University General Hospital	Tianjin		China	300052
30	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou City		China	325035
31	Tongji Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan City		China	430030
32	Tangdu Hospital	Xi'an City		China	710038
33	Aarhus Universitetshospital; Neurologisk Klinik	Aarhus N		Denmark	8200
34	Rigshospitalet; Afdeling for Hjerne- og Nervesygdomme	København Ø		Denmark	2100
35	APHP Raymond Poincare	Garches		France	92380
36	Hopital Timone Adultes; Neurologie Mal Neuro Musculaires	Marseille		France	13385
37	CHU de Nantes - Hotel Dieu	Nantes		France	44093
38	CHU Nice - Hôpital Pasteur 2; SYST NERVEUX PERIPHERIQUE MUSCLE	Nice		France	06000
39	CHU Bordeaux	Pessac		France	33604
40	St. Josef-Hospital, Klinik für Neurologie	Bochum		Germany	44791
41	Universitätsklinikum Essen (AöR); Klinik für Neurologie	Essen		Germany	45147
42	Univeristätsklinikum Leipzig; Klinik und Poliklinik für Neurologie	Leipzig		Germany	04103
43	Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie	Münster		Germany	48149
44	Azienda Ospedaliera A. Cardarelli; Dipartimento medico polispecialistico	Napoli	Campania	Italy	80131
45	A.O. Sant'Andrea; UOC Neurologia, Dip. di Neuroscienze, Salute Mentale e Organi di Senso (NESMOS)	Roma	Lazio	Italy	00189
46	Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari	Milano	Lombardia	Italy	20133
47	Fondazione Istituto Neurologico Mondino IRCCS; SC Neuroncologia e neuroinfiammazione	Pavia	Lombardia	Italy	27100
48	A.R.N.A.S. Civico Di Cristina Benfratelli; U.O.C. Neurologia con Stroke Unit	Palermo	Sicilia	Italy	90127
49	Ospedale Cà Foncello; S.C Neurologia	Treviso	Veneto	Italy	31100
50	Juntendo University Hospital; Neurology	Bunkyo-ku		Japan	113-8431
51	Chiba University Hospital; Neurology	Chiba-shi, Chiba		Japan	260-8677
52	General Hanamaki Hospital; Neurology	Hanamaki, Iwate		Japan	025-0082
53	Hiroshima University Hospital	Hiroshima		Japan	734-8551
54	Sapporo Medical University Hospital; Neurology	Hokkaido		Japan	060-8543
55	NHO Hokkaido Medical Center	Hokkaido		Japan	063-0005
56	Kagawa University Hospital; Neurology	Kagawa		Japan	761-0793
57	St. Marianna University Hospital	Kanagawa		Japan	216-8511
58	Saitama Medical Center; Neurology	Kawagoe-shi, Saitama		Japan	350-8550
59	Nagasaki Kawatana Medical Center; Neurology	Nagasaki		Japan	859-3615
60	International University of Health and Welfare Narita Hospital; Neurology	Narita, Chiba		Japan	286-0124
61	Kindai University Hospital; Neurology	Osaka		Japan	589-8511
62	Osaka Toneyama Medical Center; Neurology	Osaka		Japan
63	Dokkyo Medical University Saitama Medical Center; Neurology	Saitama		Japan	343-8555
64	Tokyo Women's Medical University Hospital; Neurology	Shinjuku-ku		Japan	162-8666
65	Seirei Hamamatsu General Hospital	Shizuoka		Japan	430-8558
66	Osaka University Hospital; Neurology	Suita		Japan	565-0871
67	Tokyo Medical And Dental University, Medical Hospital; Neurology	Tokyo		Japan	113-8519
68	Tokyo Medical University Hospital	Tokyo		Japan	160-0023
69	Kyungpook National University Chilgok Hospital	Daegu		Korea, Republic of	41404
70	Pusan National University Yangsan Hospital	Gyeongsangnam-do		Korea, Republic of	50612
71	Korea University Anam Hospital	Seoul		Korea, Republic of	02841
72	Severance Hospital, Yonsei University Health System	Seoul		Korea, Republic of	03722
73	Samsung Medical Center	Seoul		Korea, Republic of	06351
74	Amsterdam UMC Location AMC	Amsterdam		Netherlands	1105 AZ
75	Klinika Neurologii Dorosłych, Uniwersyteckie Centrum Kliniczne	Gdańsk		Poland	80-952
76	Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K	Krakow		Poland	31-505
77	Zespol Poradni Specjalistycznych - Poradnia Neurologiczna; Szpital Uniwersytecki w Krakowie	Kraków		Poland	31-503
78	FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency	Krasnoyarsk	Krasnojarsk	Russian Federation	660037
79	Krasnoyarsk State Medical Academy	Krasnoyarsk	Krasnojarsk	Russian Federation	660049
80	National Center of Social Significant Disease	Sankt-peterburg	Leningrad	Russian Federation	197110
81	Novosibirsk State Regional Clinical Hospital	Novosibirsk		Russian Federation	630087
82	Leningrad Regional Clinical Hospital	St Petersburg		Russian Federation	194291
83	Hospital Universitari de Bellvitge; Servicio de Neurologia	L'Hospitalet de Llobregat	Barcelona	Spain	08907
84	Hospital de Donostia Unidad Demencias; Consultas de Neurología	San Sebastian	Guipuzcoa	Spain	20080
85	Hospital Universitario Infanta Sofia; Servicio de Neurologia	San Sebastian de los Reyes	Madrid	Spain	28702
86	Clinica Universitaria de Navarra; Servicio de Neurología	Pamplona	Navarra	Spain	31008
87	Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia	Barcelona		Spain	08041
88	Hospital General Universitario Gregorio Marañon; Servicio de Neurologia	Madrid		Spain	28007
89	Hospital Universitario la Fe; Servicio de Neurologia	Valencia		Spain	46026
90	Taipei Veterans General Hospital-Neurology	Taipei		Taiwan	11217
91	Chang Gung Medical Foundation Linkou Branch	Taoyuan City		Taiwan	333
92	Hacettepe University Medical Faculty; Neurology	Ankara		Turkey	06100
93	Ege University Medical Faculty	Izmir		Turkey	35100
94	Kocaeli University Hospital; Department of Neurology	Kocaeli		Turkey	41380
95	Ondokuz Mayis Univ. Med. Fac.; Neurology	Samsun		Turkey	55139

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT04963270

Other Study ID Numbers:

WN42636

First Posted:

Jul 15, 2021

Last Update Posted:

Aug 17, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Myasthenia Gravis

Muscle Weakness

Study Results

No Results Posted as of Aug 17, 2022