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De klinische studie NCT05503264 (Cielo) voor NMDAR Autoimmune Encephalitis, LGI1 Autoimmune Encephalitis is rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
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RocheA Study to Evaluate the Efficacy, Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Satralizumab in Participants With Anti-N-methyl-D-aspartic Acid Receptor (NMDAR) or Anti-leucine-rich Glioma-inactivated 1 (LGI1) Encephalitis (Cielo) Fase 3 152
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De klinische studie NCT05503264 (Cielo) onderzoekt behandeling bij NMDAR Autoimmune Encephalitis, LGI1 Autoimmune Encephalitis. Deze Fase 3 interventioneel-studie heeft de status rekruterend. Het doel is om 152 deelnemers te includeren vanaf 27 september 2022. De studie wordt geleid door Roche en de voltooiing is gepland op 14 december 2029. Laatste update op ClinicalTrials.gov: 6 maart 2026.
Beknopte samenvatting
The purpose of this study is to assess the efficacy, safety, PK, and PD of satralizumab in participants with NMDAR and LGI1 encephalitis.
Officiële titel
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
Aandoeningen
NMDAR Autoimmune EncephalitisLGI1 Autoimmune EncephalitisAndere studie-ID's
- Cielo
- WN43174
- 2021-002395-39 (EudraCT-nummer)
- 2023-504226-18-00 (EU-studienummer (CTIS))
NCT-ID
Startdatum (Werkelijk)
2022-09-27
Laatste update geplaatst
2026-03-06
Verwachte einddatum
2029-12-14
Inschrijving (Geschat)
152
Studietype
Interventioneel
FASE
Fase 3
Status
Rekruterend
Primaire doel
Behandeling
Toewijzing
Gerandomiseerd
Interventiemodel
Parallel
Blindering
Viervoudig blind
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
ExperimenteelNMDAR Autoimmune Encephalitis (AIE) Cohort Adults and adolescents with definite or probable NMDAR encephalitis | Satralizumab In Part 1, study drug will be administered after all other study-related procedures have been performed at a site visit at Weeks 0, 2, 4, and every 4 weeks (Q4W) thereafter. Participants will receive satralizumab according to body weight. Study drug will be administered by subcutaneous (SC) injection in the abdominal or femoral region after all other study-related procedures have been performed at a site visit. In Pa...Toon meer |
ExperimenteelLGI1 AIE Cohort Adults with LGI1 encephalitis | Satralizumab In Part 1, study drug will be administered after all other study-related procedures have been performed at a site visit at Weeks 0, 2, 4, and every 4 weeks (Q4W) thereafter. Participants will receive satralizumab according to body weight. Study drug will be administered by subcutaneous (SC) injection in the abdominal or femoral region after all other study-related procedures have been performed at a site visit. In Pa...Toon meer |
Placebo-comparatorNMDAR AIE Placebo Cohort Adults and adolescents with definite or probable NMDAR encephalitis | PLACEBO Satralizumab placebo prefilled syringe (PFS) is identical in composition to satralizumab PFS, but does not contain the satralizumab active ingredient and will be identical in appearance and packaging to satralizumab. A PFS (assembled with an needle safety device \[NSD\] and extended finger flange) filled with 0.5 milliliters (mL) of solution, corresponding to 60 milligrams (mg) satralizumab, may be used in Part 2 onc...Toon meer |
Placebo-comparatorLGI1 AIE Placebo Cohort Adults with LGI1 encephalitis | PLACEBO Satralizumab placebo prefilled syringe (PFS) is identical in composition to satralizumab PFS, but does not contain the satralizumab active ingredient and will be identical in appearance and packaging to satralizumab. A PFS (assembled with an needle safety device \[NSD\] and extended finger flange) filled with 0.5 milliliters (mL) of solution, corresponding to 60 milligrams (mg) satralizumab, may be used in Part 2 onc...Toon meer |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Part 1: Proportion of Participants in NMDAR AIE Cohort With Modified Rankin Scale (mRS) Score Improvement ≥ 1 From Baseline and no Use of Rescue Therapy at Week 24 | Baseline up to Week 24 | |
Part 1: Proportion of Participants in LGI1 AIE Cohort With mRS Score Improvement ≥ 1 From Baseline and no Use of Rescue Therapy at Week 52 | Baseline up to Week 52 | |
Part 2: Percentage of Participants With Adverse Events (AEs) | From Week 52 up to 2 years |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Part 1 (NMDAR AIE Cohort and LGI1 Cohort): Time to mRS Score Improvement ≥ 1 From Baseline Without Use of Rescue Therapy | Baseline up to Week 52 | |
Part 1 (NMDAR AIE Cohort and LGI1 AIE Cohort): Time to Rescue Therapy | Baseline up to Week 52 | |
Part 1 (NMDAR AIE Cohort and LGI1 AIE Cohort): Proportion of Participants With Sustained Seizure Cessation at Week 24 | Sustained seizure cessation is defined as 4 consecutive weeks of no seizures maintained until Week 24 and no use of rescue therapy. | Baseline up to Week 24 |
Part 1 (NMDAR AIE Cohort): Change in Clinical Assessment Scale in Autoimmune Encephalitis (CASE) Score From Baseline at Week 24 | Baseline up to Week 24 | |
Part 1 (LGI1 AIE Cohort): Change in CASE Score From Baseline at Week 52 | Baseline up to Week 52 | |
Part 1 (NMDAR AIE Cohort): Montreal Overall Cognitive Assessment (MOCA) Total Score at Week 24 | Baseline up to Week 24 | |
Part 1 (LGI1 AIE Cohort): MOCA Total Score at Week 52 | Baseline up to Week 52 | |
Part 1 (LGI1 AIE Cohort): Rey Auditory Verbal Learning Test (RAVLT) Score at Week 52 | Baseline up to Week 52 | |
Part 1 (NMDAR AIE Cohort): mRS Score at Week 24 (as Measured on a 7-point Scale) | Baseline up to Week 24 | |
Part 1: Percentage of Participants With AEs | Severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE V5.0) | Baseline, Week 52, 2 Years |
Parts 1 and 2: Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) | The C-SSRS includes 'yes' or 'no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present (from 1 to 5, with 5 being the most severe). Greater lethality or potential lethality of suicidal behaviors (endorsed on the behavior subscale) indicates increased risk. | Baseline up to 2 years |
Deelname-assistent
Geschiktheidscriteria
Leeftijd van deelnemers
Kind, Volwassene, Oudere volwassene
Minimumleeftijd
12 Years
Geslachten die in aanmerking komen voor de studie
Allen
- 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
- Any untreated teratoma or thymoma at baseline visit (randomization)
- History of carcinoma or malignancy, unless deemed cured by adequate treatment with no evidence of recurrence for ≥ 5 years before screening
- For participants with NMDAR AIE, history of negative anti-NMDAR antibody in cerebrospinal fluid (CSF) using a cell-based assay within 9 months of symptom onset
- Historically known positivity to an intracellular antigen with high cancer association or glutamate decarboxylase 65 (GAD-65)
- Historically known positivity to any cell surface neuronal antibodies other than NMDAR and LGI1, in the absence of NMDAR and LGI1 antibody positivity
- Confirmed paraneoplastic encephalitis
- Confirmed central or peripheral nervous system demyelinating disease
- Alternative causes of associated symptoms
- History of herpes simplex virus encephalitis in the previous 24 weeks
- Any previous/concurrent treatment with interleukin-6 (IL-6) inhibitory therapy (e.g., tocilizumab), alemtuzumab, total body irradiation, or bone marrow transplantation
- Any previous treatment with anti-cluster of differentiation 19 antibody (CD19 antibody), complement inhibitors, neonatal Fc receptor antagonists, anti-B-lymphocyte stimulator monoclonal antibody
- Any previous treatment with T-cell depleting therapies, cladribine, or mitoxantrone
- Treatment with oral cyclophosphamide within 1 year prior to baseline
- Treatment with any investigational drug (including bortezomib) within 24 weeks prior to screening
- Concurrent use of more than one immunosuppressive therapy (IST) as background therapy
- Contraindication to all of the following rescue treatments: rituximab, intravenous immunoglobulin (IVIG), high-dose corticosteroids, or intravenous (IV) cyclophosphamide
- Any surgical procedure, except laparoscopic surgery or minor surgeries within 4 weeks prior to baseline, excluding surgery for thymoma or teratoma removal
- Planned surgical procedure during the study
- Evidence of progressive multifocal leukoencephalopathy
- Evidence of serious uncontrolled concomitant diseases
- Congenital or acquired immunodeficiency, including human immunodeficiency virus (HIV) infection
- Active or presence of recurrent bacterial, viral, fungal, mycobacterial infection, or other infection
- Infection requiring hospitalization or treatment with IV anti-infective agents within 4 weeks prior to baseline visit
- Positive hepatitis B (HBV) and hepatitis C (HCV) test at screening
- Evidence of latent or active tuberculosis (TB)
- History of drug or alcohol abuse within 1 year prior to baseline
- History of diverticulitis or concurrent severe gastrointestinal (GI) disorders that, in the investigator's opinion, may lead to increased risk of complications such as GI perforation
- Receipt of live or live-attenuated vaccine within 6 weeks prior to baseline visit
- History of blood donation (1 unit or more), plasma donation or platelet donation within 90 days prior to screening
- History of severe allergic reaction to a biologic agent
- History of suicide attempt within 3 years prior to screening except if this is clearly associated with and occurs during the acute phase of LGI-1 or NMDAR encephalitis
- Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes safe participation in and completion of the study
- Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of study drug
Chugai PharmaceuticalCentraal Contactpersoon
Contact: Reference Study ID Number: WN43174, https://forpatients.roche.com/, 888-662-6728 (U.S.), [email protected]
Contact: Global Medical Information:, [email protected]
92 Studielocaties in 18 landen
Erasmus MC, Rotterdam, 3015 GD, Netherlands
Rekruterend
Alabama
University of Alabama at Birmingham, Birmingham, Alabama, 35233, United States
Rekruterend
California
UC San Diego, La Jolla, California, 92037, United States
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Hoag Memorial Hospital, Newport Beach, California, 92658, United States
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UCSF- Multiple Sclerosis Centre, San Francisco, California, 94158, United States
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Colorado
University of Colorado, Aurora, Colorado, 80045, United States
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District of Columbia
Childrens National Health Center, Washington D.C., District of Columbia, 20010, United States
Rekruterend
Georgia
Children's Healthcare of Atlanta Center for Advanced Pediatrics, Atlanta, Georgia, 30329, United States
Rekruterend
Iowa
University of Iowa Hospitals & Clinics, Iowa City, Iowa, 52242, United States
Rekruterend
Maryland
University of Maryland Medical Center, Baltimore, Maryland, 21201, United States
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Johns Hopkins Hospital, Baltimore, Maryland, 21205, United States
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Massachusetts
Brigham and Women's Hospital Department of Neurology, Boston, Massachusetts, 02115, United States
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Minnesota
Mayo Clinic - Rochester, Rochester, Minnesota, 55905, United States
Rekruterend
New York
NYU-Langone Medical Center, New York, New York, 10016, United States
Rekruterend
North Carolina
Duke University Medical Center, Durham, North Carolina, 27710, United States
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Ohio
University Hospitals of Cleveland, Cleveland, Ohio, 44106, United States
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Cleveland Clinic Foundation, Cleveland, Ohio, 44915, United States
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Pennsylvania
Univ of Pennsylvania Med Ctr, Philadelphia, Pennsylvania, 19104, United States
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Texas
University of Texas at Houston, Houston, Texas, 77030, United States
Rekruterend
Washington
Swedish Neuroscience Institute, Seattle, Washington, 98122, United States
Ingetrokken
Wisconsin
Medical College of Wisconsin, Milwaukee, Wisconsin, 53226, United States
Rekruterend
Hospital Ramos Mejía, CABA, C1221ADC, Argentina
Actief, niet rekruterend
Hospital Britanico, Ciudad Autonoma Bs As, C1280AEB, Argentina
Rekruterend
Sanatorio del Sur S.A., San Miguel de Tucumán, T4000IDK, Argentina
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Kepler Universitätsklinikum GmbH - Neuromed Campus, Linz, 4020, Austria
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Medizinische Universität Wien, Vienna, 1090, Austria
Ingetrokken
Ceará
Hospital Geral de Fortaleza, Fortaleza, Ceará, 60175-295, Brazil
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Espírito Santo
CEDOES - Diagnóstico e Pesquisa, Vitória, Espírito Santo, 29055-450, Brazil
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Paraná
Instituto de Neurologia de Curitiba, Curitiba, Paraná, 81210-310, Brazil
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São Paulo
Centro de Pesquisas Clinicas, São Paulo, São Paulo, 01228-200, Brazil
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Hospital Israelita Albert Einstein, São Paulo, São Paulo, 05652-000, Brazil
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Beijing Children's Hospital, Capital Medical University, Beijing, 100045, China
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Beijing Tongren Hospital, Beijing, 100730, China
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Beijing Tiantan Hospital,Capital Medical University, Beijing, China
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The First Hospital of Jilin University, Changchun, 130021, China
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The Second Xiangya Hospital of Central South University, Changsha, 410011, China
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West China Hospital - Sichuan University, Chengdu, 610047, China
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Fujian Medical University Union Hospital, Fuzhou, 350001, China
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Guangzhou First Municipal People's Hospital, Guangzhou, 510180, China
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Affiliated Hospital of Jining Medical University, Jining, 272029, China
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Huashan Hospital, Fudan University, Shanghai, 200040, China
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The First Hospital of Shanxi Medical University, Taiyuan, 030001, China
Rekruterend
The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, 325035, China
Afgerond
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, 430030, China
Rekruterend
Fakultni nemocnice Hradec Kralove, Hradec Králové, 500 05, Czechia
Ingetrokken
Fakultni nemocnice v Motole, Prague, 150 06, Czechia
Rekruterend
Odense Universitetshospital, Neurologisk Afdeling N, Odense C, 5000, Denmark
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Hopital neurologique Pierre Wertheimer - CHU Lyon, Bron, 69677, France
Afgerond
Hopital Pitié Salpétrière - CHU, Paris, 75651, France
Rekruterend
CHU Saint Etienne - Hôpital Nord, Saint-Etienne, 42055, France
Ingetrokken
CHRU - Hôpital Bretonneau, Tours, 37000, France
Rekruterend
Komfo Anokye Teaching Hospital, Kumasi, Ghana
Rekruterend
Hadassah University Hospital Ein Kerem, Jerusalem, 9112001, Israel
Rekruterend
Tel Aviv Sourasky Medical Center, Tel Aviv, 6423906, Israel
Rekruterend
Campania
A. O. U. Federico II, Naples, Campania, 80131, Italy
Rekruterend
AOU Seconda Università degli Studi, Naples, Campania, 80138, Italy
Rekruterend
Lazio
Ospedale Pediatrico Bambino Gesù, Rome, Lazio, 00165, Italy
Ingetrokken
Liguria
Irccs A.O.U.San Martino Ist, Genoa, Liguria, 16132, Italy
Rekruterend
Lombardy
IRCCS Ospedale San Raffaele, Milan, Lombardy, 20132, Italy
Rekruterend
Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Lombardy, 20133, Italy
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Fondazione Istituto Neurologico Mondino IRCCS, Pavia, Lombardy, 27100, Italy
Rekruterend
Sicily
AOU Policlinico Giaccone, Palermo, Sicily, 90129, Italy
Rekruterend
Fujita Health University Hospital, Aichi, 470-1192, Japan
Rekruterend
Chiba University Hospital, Chiba, 260-8677, Japan
Actief, niet rekruterend
Kyushu University Hospital, Fukuoka, 812-8582, Japan
Afgerond
Fukuoka University Hospital, Fukuoka, 814-0180, Japan
Rekruterend
Gifu University Hospital, Gifu, 501-1194, Japan
Rekruterend
Hokkaido University Hospital, Hokkaido, 060-8648, Japan
Actief, niet rekruterend
Hyogo prefectural Kobe Children's Hospital, Hyogoken, 6500047, Japan
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Kobe University Hospital, Hyōgo, 650-0017, Japan
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Kagoshima City Hospital, Kagoshima, 890-8760, Japan
Rekruterend
St.Marianna University School of Medicine hospital, Kanagawa, 216-8511, Japan
Afgerond
Kitasato University Hospital, Kanagawa, 252-0375, Japan
Actief, niet rekruterend
Tokai University Hospital, Kanagawa, 259-1193, Japan
Rekruterend
Tohoku University Hospital, Miyagi, 980-8574, Japan
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The University of Osaka Hospital, Osaka, 565-0871, Japan
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Kindai University Hospital, Osaka, 590-0197, Japan
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Ageo Central General Hospital, Saitama, 362-8588, Japan
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Juntendo University Hospital, Tokyo, 113-8431, Japan
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Nihon University Itabashi Hospital, Tokyo, 173-8610, Japan
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Regionalny Szpital Specjalistyczny im. W. Bieganskiego, Grudzi?dz, 86-300, Poland
Ingetrokken
Szpital Uniwersytecki w Krakowie, Krakow, 30-688, Poland
Afgerond
Instytut Psychiatrii i Neurologii II Klinika Neurologiczna, Warsaw, 02-957, Poland
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SPSK nr 1, Zabrze, 41-800, Poland
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National University Hospital (NUH), Singapore, 117599, Singapore
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Seoul National University Hospital, Seoul, 03080, South Korea
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Pontevedra
Hospital Alvaro Cunqueiro, Vigo, Pontevedra, DUMMY_VALUE, Spain
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Hospital General Universitario Gregorio Marañon, Madrid, 28007, Spain
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Hospital Regional Universitario de Malaga ? Hospital General, Málaga, 29010, Spain
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Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City, 00833, Taiwan
Rekruterend
China Medical University Hospital, North Dist., 40402, Taiwan
Ingetrokken
Chang Gung Memorial Hospital - Linkou, Taoyuan, 333, Taiwan
Rekruterend