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: Recruiting
Location: See all (86) 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
RECRUITING
Birmingham
California
UC San Diego
RECRUITING
La Jolla
Hoag Memorial Hospital
RECRUITING
Newport Beach
UCSF- Multiple Sclerosis Centre
RECRUITING
San Francisco
Colorado
University of Colorado
RECRUITING
Aurora
Iowa
University of Iowa Hospitals & Clinics
RECRUITING
Iowa City
Massachusetts
Brigham and Women's Hospital Department of Neurology
RECRUITING
Boston
Maryland
Johns Hopkins Hospital
RECRUITING
Baltimore
University of Maryland Medical Center
RECRUITING
Baltimore
Minnesota
Mayo Clinic - Rochester
RECRUITING
Rochester
North Carolina
Duke University Medical Center
RECRUITING
Durham
New York
NYU-Langone Medical Center
RECRUITING
New York
Ohio
Cleveland Clinic Foundation
RECRUITING
Cleveland
University Hospitals of Cleveland
RECRUITING
Cleveland
Pennsylvania
Univ of Pennsylvania Med Ctr
RECRUITING
Philadelphia
Texas
University of Texas at Houston
RECRUITING
Houston
Washington
Swedish Neuroscience Institute
WITHDRAWN
Seattle
Wisconsin
Medical College of Wisconsin
RECRUITING
Milwaukee
Other Locations
Argentina
Hospital Ramos Mejía
ACTIVE_NOT_RECRUITING
Caba
Hospital Britanico
RECRUITING
Ciudad Autonoma Bs As
Sanatorio del Sur S.A.
RECRUITING
San Miguel De Tucumán
Austria
Kepler Universitätsklinikum GmbH - Neuromed Campus
RECRUITING
Linz
Medizinische Universität Wien
WITHDRAWN
Vienna
Brazil
Instituto de Neurologia de Curitiba
RECRUITING
Curitiba
Hospital Geral de Fortaleza
RECRUITING
Fortaleza
Centro de Pesquisas Clinicas
COMPLETED
São Paulo
Hospital Israelita Albert Einstein
RECRUITING
São Paulo
CEDOES - Diagnóstico e Pesquisa
RECRUITING
Vitória
China
Beijing Children's Hospital, Capital Medical University
RECRUITING
Beijing
Beijing Tiantan Hospital,Capital Medical University
RECRUITING
Beijing
Beijing Tongren Hospital
RECRUITING
Beijing
The First Hospital of Jilin University
RECRUITING
Changchun
The Second Xiangya Hospital of Central South University
RECRUITING
Changsha
West China Hospital - Sichuan University
RECRUITING
Chengdu
Fujian Medical University Union Hospital
RECRUITING
Fuzhou
Guangzhou First Municipal People's Hospital
RECRUITING
Guangzhou
Affiliated Hospital of Jining Medical University
RECRUITING
Jining
Huashan Hospital, Fudan University
RECRUITING
Shanghai
The First Hospital of Shanxi Medical University
RECRUITING
Taiyuan
The First Affiliated Hospital of Wenzhou Medical University
ACTIVE_NOT_RECRUITING
Wenzhou
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
RECRUITING
Wuhan
Denmark
Odense Universitetshospital, Neurologisk Afdeling N
RECRUITING
Odense C
France
Hopital neurologique Pierre Wertheimer - CHU Lyon
ACTIVE_NOT_RECRUITING
Bron
Hopital Pitié Salpétrière - CHU
RECRUITING
Paris
CHU Saint Etienne - Hôpital Nord
ACTIVE_NOT_RECRUITING
Saint-etienne
CHRU - Hôpital Bretonneau
RECRUITING
Tours
Ghana
Komfo Anokye Teaching Hospital
RECRUITING
Kumasi
Italy
Irccs A.O.U.San Martino Ist
RECRUITING
Genoa
Fondazione IRCCS Istituto Neurologico Carlo Besta
RECRUITING
Milan
IRCCS Ospedale San Raffaele
RECRUITING
Milan
A. O. U. Federico II
RECRUITING
Napoli
AOU Seconda Università degli Studi
RECRUITING
Napoli
AOU Policlinico Giaccone
RECRUITING
Palermo
Fondazione Istituto Neurologico Mondino IRCCS
RECRUITING
Pavia
Ospedale Pediatrico Bambino Gesù
WITHDRAWN
Rome
Japan
Fujita Health University Hospital
RECRUITING
Aichi
Chiba University Hospital
ACTIVE_NOT_RECRUITING
Chiba
Fukuoka University Hospital
RECRUITING
Fukuoka
Kyushu University Hospital
COMPLETED
Fukuoka
Gifu University Hospital
ACTIVE_NOT_RECRUITING
Gifu
Hokkaido University Hospital
ACTIVE_NOT_RECRUITING
Hokkaido
Kobe University Hospital
RECRUITING
Hyōgo
Hyogo prefectural Kobe Children's Hospital
RECRUITING
Hyogoken
Kagoshima City Hospital
RECRUITING
Kagoshima
Kitasato University Hospital
ACTIVE_NOT_RECRUITING
Kanagawa
St.Marianna University School of Medicine hospital
COMPLETED
Kanagawa
Tokai University Hospital
RECRUITING
Kanagawa
Tohoku University Hospital
RECRUITING
Miyagi
Kindai University Hospital
RECRUITING
Osaka
The University of Osaka Hospital
RECRUITING
Osaka
Ageo Central General Hospital
RECRUITING
Saitama
Juntendo University Hospital
RECRUITING
Tokyo
Nihon University Itabashi Hospital
ACTIVE_NOT_RECRUITING
Tokyo
Netherlands
Erasmus MC
RECRUITING
Rotterdam
Poland
Regionalny Szpital Specjalistyczny im. W. Bieganskiego
WITHDRAWN
Grudzi?dz
Szpital Uniwersytecki w Krakowie
COMPLETED
Krakow
Instytut Psychiatrii i Neurologii II Klinika Neurologiczna
RECRUITING
Warsaw
SPSK nr 1
RECRUITING
Zabrze
Republic of Korea
Seoul National University Hospital
RECRUITING
Seoul
Singapore
National University Hospital (NUH)
RECRUITING
Singapore
Spain
Hospital General Universitario Gregorio Marañon
RECRUITING
Madrid
Hospital Regional Universitario de Malaga ? Hospital General
RECRUITING
Málaga
Hospital Alvaro Cunqueiro
RECRUITING
Vigo
Taiwan
Kaohsiung Chang Gung Memorial Hospital
RECRUITING
Kaohsiung City
China Medical University Hospital
RECRUITING
North Dist.
Chang Gung Memorial Hospital - Linkou
RECRUITING
Taoyuan
Contact Information
Primary
Reference Study ID Number: WN43174, https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S.)
Backup
Global Medical Information:
global.medical_information@roche.com
Time Frame
Start Date: 2022-09-27
Estimated Completion Date: 2029-12-14
Participants
Target number of participants: 152
Treatments
Experimental: NMDAR Autoimmune Encephalitis (AIE) Cohort
Adults and adolescents with definite or probable NMDAR encephalitis
Experimental: LGI1 AIE Cohort
Adults with LGI1 encephalitis
Placebo_comparator: NMDAR AIE Placebo Cohort
Adults and adolescents with definite or probable NMDAR encephalitis
Placebo_comparator: LGI1 AIE Placebo Cohort
Adults with LGI1 encephalitis
Related Therapeutic Areas
Sponsors
Leads: Hoffmann-La Roche
Collaborators: Chugai Pharmaceutical

This content was sourced from clinicaltrials.gov