A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Basket Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients With Anti-N-methyl-D-aspartic Acid Receptor (NMDAR) or Anti-leucine-rich Glioma-inactivated 1 (LGI1) Encephalitis
Status: Active_not_recruiting
Location: See all (76) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to assess the efficacy, safety, PK, and PD of satralizumab in participants with NMDAR and LGI1 encephalitis.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:
• Reasonable exclusion of tumor or malignancy before baseline visit (randomization)
• Onset of AIE symptoms ≤ 9 months before randomization
• Meet the definition of New Onset or Incomplete Responder AIE
• For women 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 or placebo
• For participants enrolled in the extended China enrollment phase at China's sites: participants who are current residents of mainland China, Hong Kong, or Taiwan, and of Chinese ancestry
⁃ NMDAR AIE Cohort:
• Age ≥ 12 years
• Diagnosis of probable or definite NMDAR encephalitis
⁃ LGI1 AIE Cohort
• Age ≥ 18 years
• Diagnosis of LGI1 encephalitis
Locations
United States
Alabama
University of Alabama at Birmingham
Birmingham
California
UC San Diego
La Jolla
Hoag Memorial Hospital
Newport Beach
UCSF- Multiple Sclerosis Centre
San Francisco
Colorado
University of Colorado
Aurora
Washington, D.c.
Childrens National Health Center
Washington D.c.
Georgia
Children's Healthcare of Atlanta Center for Advanced Pediatrics
Atlanta
Massachusetts
Brigham and Women's Hospital Department of Neurology
Boston
Maryland
Johns Hopkins Hospital
Baltimore
University of Maryland Medical Center
Baltimore
Minnesota
Mayo Clinic - Rochester
Rochester
North Carolina
Duke University Medical Center
Durham
New York
NYU-Langone Medical Center
New York
Ohio
Cleveland Clinic Foundation
Cleveland
University Hospitals of Cleveland
Cleveland
Texas
University of Texas at Houston
Houston
Wisconsin
Medical College of Wisconsin
Milwaukee
Other Locations
Argentina
Hospital Ramos Mejía
Caba
Hospital Britanico
Ciudad Autonoma Bs As
Sanatorio del Sur S.A.
San Miguel De Tucumán
Brazil
Instituto de Neurologia de Curitiba
Curitiba
Hospital Geral de Fortaleza
Fortaleza
Centro de Pesquisas Clinicas
São Paulo
Hospital Israelita Albert Einstein
São Paulo
CEDOES - Diagnóstico e Pesquisa
Vitória
China
Beijing Children's Hospital, Capital Medical University
Beijing
Beijing Tiantan Hospital,Capital Medical University
Beijing
Beijing Tongren Hospital
Beijing
West China Hospital - Sichuan University
Chengdu
Fujian Medical University Union Hospital
Fuzhou
Affiliated Hospital of Jining Medical University
Jining
Huashan Hospital, Fudan University
Shanghai
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou
Denmark
Odense Universitetshospital, Neurologisk Afdeling N
Odense C
France
Hopital neurologique Pierre Wertheimer - CHU Lyon
Bron
Hopital Pitié Salpétrière - CHU
Paris
CHRU - Hôpital Bretonneau
Tours
Ghana
Komfo Anokye Teaching Hospital
Kumasi
Israel
Hadassah University Hospital Ein Kerem
Jerusalem
Tel Aviv Sourasky Medical Center
Tel Aviv
Italy
Irccs A.O.U.San Martino Ist
Genoa
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan
IRCCS Ospedale San Raffaele
Milan
A. O. U. Federico II
Naples
AOU Policlinico Giaccone
Palermo
Fondazione Istituto Neurologico Mondino IRCCS
Pavia
Japan
Fujita Health University Hospital
Aichi
Chiba University Hospital
Chiba
Fukuoka University Hospital
Fukuoka
Kyushu University Hospital
Fukuoka
Gifu University Hospital
Gifu
Hokkaido University Hospital
Hokkaido
Kobe University Hospital
Hyōgo
Hyogo prefectural Kobe Children's Hospital
Hyogoken
Kagoshima City Hospital
Kagoshima
Kitasato University Hospital
Kanagawa
St.Marianna University School of Medicine hospital
Kanagawa
Tokai University Hospital
Kanagawa
Tohoku University Hospital
Miyagi
Kindai University Hospital
Osaka
The University of Osaka Hospital
Osaka
Ageo Central General Hospital
Saitama
Juntendo University Hospital
Tokyo
Nihon University Itabashi Hospital
Tokyo
Netherlands
Erasmus MC
Rotterdam
Poland
Szpital Uniwersytecki w Krakowie
Krakow
Instytut Psychiatrii i Neurologii II Klinika Neurologiczna
Warsaw
SPSK nr 1
Zabrze
Republic of Korea
Seoul National University Hospital
Seoul
Singapore
National Neuroscience Institute
Singapore
National University Hospital (NUH)
Singapore
Spain
Hospital General Universitario Gregorio Marañon
Madrid
Hospital Regional Universitario de Malaga ? Hospital General
Málaga
Hospital Alvaro Cunqueiro
Vigo
Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City
Chang Gung Memorial Hospital - Linkou
Taoyuan City
Time Frame
Start Date: 2022-09-27
Completion Date: 2028-12-14
Participants
Target number of participants: 122
Treatments
Experimental: NMDAR Autoimmune Encephalitis (AIE) Cohort
Adults and adolescents with definite or probable NMDAR encephalitis will receive satralizumab as per the schedule specified in the protocol. As of Protocol Version 6, participants in Part 1 will transition to Part 2 at the time of primary analysis or at Week 52, whichever occurs first.
Experimental: LGI1 AIE Cohort
Adults with LGI1 encephalitis as per the schedule specified in the protocol.
Placebo_comparator: NMDAR AIE Placebo Cohort
Adults and adolescents with definite or probable NMDAR encephalitis will receive satralizumab placebo as per the schedule specified in the protocol. As of Protocol Version 6, participants in Part 1 will transition to Part 2 at the time of primary analysis or at Week 52, whichever occurs first.
Placebo_comparator: LGI1 AIE Placebo Cohort
Adults with LGI1 encephalitis will receive satralizumab placebo as per the schedule specified in the protocol.
Related Therapeutic Areas
Sponsors
Leads: Hoffmann-La Roche
Collaborators: Chugai Pharmaceutical