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El ensayo clínico NCT05503264 (Cielo) para NMDAR Autoimmune Encephalitis, LGI1 Autoimmune Encephalitis está reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
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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 III 152
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El ensayo clínico NCT05503264 (Cielo) está diseñado para estudiar el tratamiento de NMDAR Autoimmune Encephalitis, LGI1 Autoimmune Encephalitis. Es un estudio intervencionista de Fase III. Su estado actual es: reclutando. El estudio se inició el 27 de septiembre de 2022, con el objetivo de reclutar a 152 participantes. Dirigido por Roche, se espera que finalice el 14 de diciembre de 2029. Los datos se actualizaron por última vez en ClinicalTrials.gov el 6 de marzo de 2026.
Resumen
The purpose of this study is to assess the efficacy, safety, PK, and PD of satralizumab in participants with NMDAR and LGI1 encephalitis.
Título oficial
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
Condiciones médicas
NMDAR Autoimmune EncephalitisLGI1 Autoimmune EncephalitisOtros ID del estudio
- Cielo
- WN43174
- 2021-002395-39 (Número EudraCT)
- 2023-504226-18-00 (Número CTIS (UE))
Número del NCT
Inicio del estudio (real)
2022-09-27
Última actualización
2026-03-06
Fecha de finalización (estimada)
2029-12-14
Inscripción (prevista)
152
Tipo de estudio
Intervencionista
FASE
Fase III
Estado general
Reclutando
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Cuádruple ciego
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalNMDAR 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...Mostrar más |
ExperimentalLGI1 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...Mostrar más |
Comparador placeboNMDAR 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...Mostrar más |
Comparador placeboLGI1 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...Mostrar más |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
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 |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
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 |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Niño, Adulto, Adulto mayor
Edad mínima
12 Years
Criterios de sexo
Todos
- 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 PharmaceuticalContactos centrales del estudio
Contacto: Reference Study ID Number: WN43174, https://forpatients.roche.com/, 888-662-6728 (U.S.), [email protected]
Contacto: Global Medical Information:, [email protected]
92 Centros del estudio en 18 países
Pontevedra
Hospital Alvaro Cunqueiro, Vigo, Pontevedra, DUMMY_VALUE, Spain
Reclutando
Hospital General Universitario Gregorio Marañon, Madrid, 28007, Spain
Reclutando
Hospital Regional Universitario de Malaga ? Hospital General, Málaga, 29010, Spain
Reclutando
Hospital Ramos Mejía, CABA, C1221ADC, Argentina
Activo, no reclutando
Hospital Britanico, Ciudad Autonoma Bs As, C1280AEB, Argentina
Reclutando
Sanatorio del Sur S.A., San Miguel de Tucumán, T4000IDK, Argentina
Reclutando
Alabama
University of Alabama at Birmingham, Birmingham, Alabama, 35233, United States
Reclutando
California
UC San Diego, La Jolla, California, 92037, United States
Reclutando
Hoag Memorial Hospital, Newport Beach, California, 92658, United States
Reclutando
UCSF- Multiple Sclerosis Centre, San Francisco, California, 94158, United States
Reclutando
Colorado
University of Colorado, Aurora, Colorado, 80045, United States
Reclutando
District of Columbia
Childrens National Health Center, Washington D.C., District of Columbia, 20010, United States
Reclutando
Georgia
Children's Healthcare of Atlanta Center for Advanced Pediatrics, Atlanta, Georgia, 30329, United States
Reclutando
Iowa
University of Iowa Hospitals & Clinics, Iowa City, Iowa, 52242, United States
Reclutando
Maryland
University of Maryland Medical Center, Baltimore, Maryland, 21201, United States
Reclutando
Johns Hopkins Hospital, Baltimore, Maryland, 21205, United States
Reclutando
Massachusetts
Brigham and Women's Hospital Department of Neurology, Boston, Massachusetts, 02115, United States
Reclutando
Minnesota
Mayo Clinic - Rochester, Rochester, Minnesota, 55905, United States
Reclutando
New York
NYU-Langone Medical Center, New York, New York, 10016, United States
Reclutando
North Carolina
Duke University Medical Center, Durham, North Carolina, 27710, United States
Reclutando
Ohio
University Hospitals of Cleveland, Cleveland, Ohio, 44106, United States
Reclutando
Cleveland Clinic Foundation, Cleveland, Ohio, 44915, United States
Reclutando
Pennsylvania
Univ of Pennsylvania Med Ctr, Philadelphia, Pennsylvania, 19104, United States
Reclutando
Texas
University of Texas at Houston, Houston, Texas, 77030, United States
Reclutando
Washington
Swedish Neuroscience Institute, Seattle, Washington, 98122, United States
Retirado
Wisconsin
Medical College of Wisconsin, Milwaukee, Wisconsin, 53226, United States
Reclutando
Kepler Universitätsklinikum GmbH - Neuromed Campus, Linz, 4020, Austria
Reclutando
Medizinische Universität Wien, Vienna, 1090, Austria
Retirado
Ceará
Hospital Geral de Fortaleza, Fortaleza, Ceará, 60175-295, Brazil
Reclutando
Espírito Santo
CEDOES - Diagnóstico e Pesquisa, Vitória, Espírito Santo, 29055-450, Brazil
Reclutando
Paraná
Instituto de Neurologia de Curitiba, Curitiba, Paraná, 81210-310, Brazil
Reclutando
São Paulo
Centro de Pesquisas Clinicas, São Paulo, São Paulo, 01228-200, Brazil
Reclutando
Hospital Israelita Albert Einstein, São Paulo, São Paulo, 05652-000, Brazil
Reclutando
Beijing Children's Hospital, Capital Medical University, Beijing, 100045, China
Reclutando
Beijing Tongren Hospital, Beijing, 100730, China
Reclutando
Beijing Tiantan Hospital,Capital Medical University, Beijing, China
Reclutando
The First Hospital of Jilin University, Changchun, 130021, China
Reclutando
The Second Xiangya Hospital of Central South University, Changsha, 410011, China
Reclutando
West China Hospital - Sichuan University, Chengdu, 610047, China
Reclutando
Fujian Medical University Union Hospital, Fuzhou, 350001, China
Reclutando
Guangzhou First Municipal People's Hospital, Guangzhou, 510180, China
Reclutando
Affiliated Hospital of Jining Medical University, Jining, 272029, China
Reclutando
Huashan Hospital, Fudan University, Shanghai, 200040, China
Reclutando
The First Hospital of Shanxi Medical University, Taiyuan, 030001, China
Reclutando
The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, 325035, China
Completado
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, 430030, China
Reclutando
Fakultni nemocnice Hradec Kralove, Hradec Králové, 500 05, Czechia
Retirado
Fakultni nemocnice v Motole, Prague, 150 06, Czechia
Reclutando
Odense Universitetshospital, Neurologisk Afdeling N, Odense C, 5000, Denmark
Reclutando
Hopital neurologique Pierre Wertheimer - CHU Lyon, Bron, 69677, France
Completado
Hopital Pitié Salpétrière - CHU, Paris, 75651, France
Reclutando
CHU Saint Etienne - Hôpital Nord, Saint-Etienne, 42055, France
Retirado
CHRU - Hôpital Bretonneau, Tours, 37000, France
Reclutando
Komfo Anokye Teaching Hospital, Kumasi, Ghana
Reclutando
Hadassah University Hospital Ein Kerem, Jerusalem, 9112001, Israel
Reclutando
Tel Aviv Sourasky Medical Center, Tel Aviv, 6423906, Israel
Reclutando
Campania
A. O. U. Federico II, Naples, Campania, 80131, Italy
Reclutando
AOU Seconda Università degli Studi, Naples, Campania, 80138, Italy
Reclutando
Lazio
Ospedale Pediatrico Bambino Gesù, Rome, Lazio, 00165, Italy
Retirado
Liguria
Irccs A.O.U.San Martino Ist, Genoa, Liguria, 16132, Italy
Reclutando
Lombardy
IRCCS Ospedale San Raffaele, Milan, Lombardy, 20132, Italy
Reclutando
Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Lombardy, 20133, Italy
Reclutando
Fondazione Istituto Neurologico Mondino IRCCS, Pavia, Lombardy, 27100, Italy
Reclutando
Sicily
AOU Policlinico Giaccone, Palermo, Sicily, 90129, Italy
Reclutando
Fujita Health University Hospital, Aichi, 470-1192, Japan
Reclutando
Chiba University Hospital, Chiba, 260-8677, Japan
Activo, no reclutando
Kyushu University Hospital, Fukuoka, 812-8582, Japan
Completado
Fukuoka University Hospital, Fukuoka, 814-0180, Japan
Reclutando
Gifu University Hospital, Gifu, 501-1194, Japan
Reclutando
Hokkaido University Hospital, Hokkaido, 060-8648, Japan
Activo, no reclutando
Hyogo prefectural Kobe Children's Hospital, Hyogoken, 6500047, Japan
Reclutando
Kobe University Hospital, Hyōgo, 650-0017, Japan
Reclutando
Kagoshima City Hospital, Kagoshima, 890-8760, Japan
Reclutando
St.Marianna University School of Medicine hospital, Kanagawa, 216-8511, Japan
Completado
Kitasato University Hospital, Kanagawa, 252-0375, Japan
Activo, no reclutando
Tokai University Hospital, Kanagawa, 259-1193, Japan
Reclutando
Tohoku University Hospital, Miyagi, 980-8574, Japan
Reclutando
The University of Osaka Hospital, Osaka, 565-0871, Japan
Reclutando
Kindai University Hospital, Osaka, 590-0197, Japan
Reclutando
Ageo Central General Hospital, Saitama, 362-8588, Japan
Reclutando
Juntendo University Hospital, Tokyo, 113-8431, Japan
Reclutando
Nihon University Itabashi Hospital, Tokyo, 173-8610, Japan
Reclutando
Erasmus MC, Rotterdam, 3015 GD, Netherlands
Reclutando
Regionalny Szpital Specjalistyczny im. W. Bieganskiego, Grudzi?dz, 86-300, Poland
Retirado
Szpital Uniwersytecki w Krakowie, Krakow, 30-688, Poland
Completado
Instytut Psychiatrii i Neurologii II Klinika Neurologiczna, Warsaw, 02-957, Poland
Reclutando
SPSK nr 1, Zabrze, 41-800, Poland
Reclutando
National University Hospital (NUH), Singapore, 117599, Singapore
Reclutando
Seoul National University Hospital, Seoul, 03080, South Korea
Reclutando
Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City, 00833, Taiwan
Reclutando
China Medical University Hospital, North Dist., 40402, Taiwan
Retirado
Chang Gung Memorial Hospital - Linkou, Taoyuan, 333, Taiwan
Reclutando