Clinical trial NCT05271409: A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients With Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease
Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab As Monotherapy Or In Addition To Baseline Therapy In Patients With Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: Chugai Pharmaceutical
First posted: 2022-03-09
Enrollment: 152
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of the study is to evaluate the efficacy of satralizumab compared with placebo based on time from randomization to the first occurrence of an adjudicated MOGAD relapse in the double-blind (DB) treatment period


Eligibility criteria: Inclusion criteria

* Participants who are aged \>=12 years at the time of signing Informed Consent Form
* Confirmed diagnosis of MOGAD with a history of \>=1 MOGAD relapse in the 12 months prior to screening or \>=2 attacks in the 24 months prior to screening
* Expanded Disability Status Scale (EDSS) score of 0-6.5 at screening
* Best corrected visual acuity (HCVA) better than 20/800 in each eye at screening
* Participants receiving either no or ongoing chronic immunosuppressant treatment (IST) for MOGAD at the time of screening
* For women of childbearing potential: participants who agree to remain abstinent or use adequate contraception during the treatment period and for at least 3 months after the final dose of satralizumab

Exclusion criteria

* Presence of aquaporin-4-antibodies (AQP4-IgG) in the serum
* History of anti-N-methyl-d-aspartate receptor (NMDAR) encephalitis
* Any concomitant disease other than MOGAD that may require treatment with ISTs or OCS or intravenous (IV) corticosteroids at doses \>20 mg prednisone equivalent per day for \>21 days during the study
* Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of satralizumab
* Participants with active or presence of recurrent bacterial, viral, fungal, mycobacterial infection, or other infection at baseline
* Participants with evidence of latent or active tuberculosis (excluding patients receiving chemoprophylaxis for latent tuberculosis infection)
* Participants with positive screening tests for hepatitis B and C
* Receipt of live or live attenuated vaccine within 6 weeks prior to baseline
* History of severe allergic reaction to a biologic agent

Primary outcomes:
measure: Time from randomization to the first occurrence of a MOGAD relapse in the DB treatment period, as determined by an adjudication committee (CEC)
timeFrame: Up to approximately 44 months
Secondary outcomes:
measure: Annualized rate of adjudicated MOGAD relapses
timeFrame: Up to approximately 44 months
measure: Annualized rate of active lesions on MRI of the neuroaxis
timeFrame: Up to approximately 44 months
measure: Proportion of participants receiving rescue therapy
timeFrame: Up to approximately 44 months
measure: Annualized rate of inpatient hospitalizations
timeFrame: Up to approximately 44 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Scottsdale
country: United States
facility: Mayo Clinic- Scottsdale
state: Arizona
city: Orange
country: United States
facility: University of California Irvine - Manchester Pavilion
state: California
city: Aurora
country: United States
facility: University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center)
state: Colorado
city: Washington
country: United States
facility: Medstar Georgetown University Hospital
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida College of Medicine Gainesville
state: Florida
city: Jacksonville
country: United States
facility: Nemours Children's Clinic - of the Nemours Foundation
state: Florida
city: Savannah
country: United States
facility: Meridian Clinical Research, LLC
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Northbrook
country: United States
facility: Consultants in Neurology Ltd
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Owosso
country: United States
facility: Memorial Healthcare Institute for Neurosciences and Multiple Sclerosis
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic - Rochester
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine in St. Louis
state: Missouri
city: New York
country: United States
facility: NYU Langone
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: OhioHealth Research Institute
state: Ohio
city: Greenville
country: United States
facility: Premier Neurology
state: South Carolina
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Camperdown
country: Australia
facility: Brain and Mind Research Institute
state: New South Wales
city: New Lambton
country: Australia
facility: John Hunter Hospital
state: New South Wales
city: Randwick
country: Australia
facility: Sydney Children's Hospital
state: New South Wales
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Fitzroy
country: Australia
facility: St Vincent's Hospital Melbourne
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Nedlands
country: Australia
facility: Perron Institute for Neurological and Translational Science
state: Western Australia
city: Curitiba
country: Brazil
facility: Instituto de Neurologia de Curitiba
state: Paraná
city: Porto Alegre
country: Brazil
facility: Instituto do Cerebro do Rio Grande do Sul
state: Rio Grande Do Sul
city: Sao Paulo
country: Brazil
facility: Centro de Pesquisas Clinicas
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: Hospital Universitario Gaffree e Guinle
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
city: Toronto
country: Canada
facility: Unity Health Toronto - St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Montreal
country: Canada
facility: MUCH - Montreal Neurological Institute & Hospital
state: Quebec
city: Bron
country: France
facility: Hopital Pierre Wertheimer
city: Le Kremlin Bicêtre
country: France
facility: CH de Bicêtre
city: Toulouse
country: France
facility: CHU de Toulouse - Hôpital Purpan
city: Berlin
country: Germany
facility: NeuroCure Clinical Research Center (NCRC)
city: Bochum
country: Germany
facility: St. Josef-Hospital, Klinik für Neurologie
city: Datteln
country: Germany
facility: Vestische Kinder- und Jugendklinik Datteln
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
city: Kiel
country: Germany
facility: Neurology UKSH Campus Kiel
city: Mannheim
country: Germany
facility: Universitätsklinikum Mannheim
city: Munich
country: Germany
facility: Klinikum Großhadern, LMU
city: Jerusalem
country: Israel
facility: Hadassah University Hospital Ein Kerem
city: Roma
country: Italy
facility: Ospedale Pediatrico Bambino Gesù
state: Lazio
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
state: Lombardia
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Neurologico Carlo Besta
state: Lombardia
city: Pavia
country: Italy
facility: Fondazione Istituto Neurologico Mondino IRCCS
state: Lombardia
city: Orbassano
country: Italy
facility: Azienda Sanitaria Ospedaliera S. Luigi Gonzaga
state: Piemonte
city: Catania
country: Italy
facility: AOU Policlinico V. Emanuele - P.O G. Rodolico
state: Sicilia
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona
state: Veneto
city: Chiba
country: Japan
facility: Chiba University Hospital
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Fukushima
country: Japan
facility: Southern Tohoku Medical Clinic
city: Hyogo
country: Japan
facility: Kobe University Hospital
city: Kanagawa
country: Japan
facility: Kitasato University Hospital
city: Miyagi
country: Japan
facility: Tohoku University Hospital
city: Miyagi
country: Japan
facility: Tohoku Medical and Pharmaceutical University Hospital
city: Osaka
country: Japan
facility: Osaka University Hospital
city: Saitama
country: Japan
facility: Saitama Medical Center
city: Tokyo
country: Japan
facility: The Jikei University Hospital
city: Tokyo
country: Japan
facility: Juntendo University Hospital
city: Tokyo
country: Japan
facility: Tokyo Medical University Hospital
city: Tokyo
country: Japan
facility: Keio University Hospital
city: Tokyo
country: Japan
facility: Tokyo Women's Medical University Hospital
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: