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הניסוי הקליני NCT05503264 (Cielo) עבור NMDAR Autoimmune Encephalitis, LGI1 Autoimmune Encephalitis הוא מגייס. לכל הפרטים, עיינו בתצוגת הכרטיסים של רדאר ניסויים קליניים ובכלי הגילוי של AI. אפשר גם לשאול כל דבר כאן. | ||
מחקר אחד תואם לקריטריוני המסנן
תצוגת כרטיסים
חזרה לחיפוש
רושA 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) שלב III 152
פרטי הניסויים הקליניים זמינים בעיקר באנגלית. רדאר קליני AI יכול לעזור! לחץ על 'הסבר את המחקר' כדי לצפות ולשוחח על מידע מהמחקר בשפה המועדפת עליך.
ניסוי קליני NCT05503264 (Cielo) מתקיים כדי לבדוק את טיפול עבור NMDAR Autoimmune Encephalitis, LGI1 Autoimmune Encephalitis. זהו מחקר שלב III מסוג התערבותי שנמצא כעת במצב מגייס. המחקר התחיל ב-27 בספטמבר 2022 ומתוכנן לכלול 152 משתתפים. המחקר מנוהל על ידי רוש וצפוי להסתיים ב-14 בדצמבר 2029. מידע זה עודכן לאחרונה באתר ClinicalTrials.gov ב-6 במרץ 2026.
סיכום קצר
The purpose of this study is to assess the efficacy, safety, PK, and PD of satralizumab in participants with NMDAR and LGI1 encephalitis.
כותרת רשמית
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
מצבים רפואיים
NMDAR Autoimmune EncephalitisLGI1 Autoimmune Encephalitisמזהי מחקר נוספים
- Cielo
- WN43174
- 2021-002395-39 (מספר EudraCT)
- 2023-504226-18-00 (מספר מחקר של האיחוד האירופי (CTIS))
מספר NCT
תחילת המחקר (בפועל)
2022-09-27
עדכון אחרון שפורסם
2026-03-06
סיום המחקר (מוערך)
2029-12-14
משתתפים (מתוכנן)
152
סוג המחקר
התערבותי
שלב
שלב III
סטטוס
מגייס
מטרה ראשית
טיפול
הקצאת טיפול
אקראי
דגם מתערב
קבוצות מקבילות
עיוורון
מרובע
זרועות / התערבויות
| קבוצת משתתפים/זרוע | התערבות/טיפול |
|---|---|
ניסיNMDAR 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...הצג עוד |
ניסיLGI1 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...הצג עוד |
פלצבו להשוואהNMDAR AIE Placebo Cohort Adults and adolescents with definite or probable NMDAR encephalitis | פלצבו 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...הצג עוד |
פלצבו להשוואהLGI1 AIE Placebo Cohort Adults with LGI1 encephalitis | פלצבו 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...הצג עוד |
מדדי תוצאה ראשיים
מדדי תוצאה משניים
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
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 |
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
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 |
עוזר השתתפות
קריטריוני זכאות
גילאים מוערכים למחקר
ילד, מבוגר, גיל שלישי
גיל מינימלי למחקר
12 Years
מגדרים מוערכים למחקר
הכל
- 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
צ'וגאי פרמצבטיקהאיש קשר מרכזי למחקר
איש קשר: Reference Study ID Number: WN43174, https://forpatients.roche.com/, 888-662-6728 (U.S.), [email protected]
איש קשר: Global Medical Information:, [email protected]
92 מיקומי המחקר ב-18 מדינות
Hadassah University Hospital Ein Kerem, Jerusalem, 9112001, Israel
מגייס
Tel Aviv Sourasky Medical Center, Tel Aviv, 6423906, Israel
מגייס
Alabama
University of Alabama at Birmingham, Birmingham, Alabama, 35233, United States
מגייס
California
UC San Diego, La Jolla, California, 92037, United States
מגייס
Hoag Memorial Hospital, Newport Beach, California, 92658, United States
מגייס
UCSF- Multiple Sclerosis Centre, San Francisco, California, 94158, United States
מגייס
Colorado
University of Colorado, Aurora, Colorado, 80045, United States
מגייס
District of Columbia
Childrens National Health Center, Washington D.C., District of Columbia, 20010, United States
מגייס
Georgia
Children's Healthcare of Atlanta Center for Advanced Pediatrics, Atlanta, Georgia, 30329, United States
מגייס
Iowa
University of Iowa Hospitals & Clinics, Iowa City, Iowa, 52242, United States
מגייס
Maryland
University of Maryland Medical Center, Baltimore, Maryland, 21201, United States
מגייס
Johns Hopkins Hospital, Baltimore, Maryland, 21205, United States
מגייס
Massachusetts
Brigham and Women's Hospital Department of Neurology, Boston, Massachusetts, 02115, United States
מגייס
Minnesota
Mayo Clinic - Rochester, Rochester, Minnesota, 55905, United States
מגייס
New York
NYU-Langone Medical Center, New York, New York, 10016, United States
מגייס
North Carolina
Duke University Medical Center, Durham, North Carolina, 27710, United States
מגייס
Ohio
University Hospitals of Cleveland, Cleveland, Ohio, 44106, United States
מגייס
Cleveland Clinic Foundation, Cleveland, Ohio, 44915, United States
מגייס
Pennsylvania
Univ of Pennsylvania Med Ctr, Philadelphia, Pennsylvania, 19104, United States
מגייס
Texas
University of Texas at Houston, Houston, Texas, 77030, United States
מגייס
Washington
Swedish Neuroscience Institute, Seattle, Washington, 98122, United States
נסוג
Wisconsin
Medical College of Wisconsin, Milwaukee, Wisconsin, 53226, United States
מגייס
Hospital Ramos Mejía, CABA, C1221ADC, Argentina
פעיל, לא מגייס
Hospital Britanico, Ciudad Autonoma Bs As, C1280AEB, Argentina
מגייס
Sanatorio del Sur S.A., San Miguel de Tucumán, T4000IDK, Argentina
מגייס
Kepler Universitätsklinikum GmbH - Neuromed Campus, Linz, 4020, Austria
מגייס
Medizinische Universität Wien, Vienna, 1090, Austria
נסוג
Ceará
Hospital Geral de Fortaleza, Fortaleza, Ceará, 60175-295, Brazil
מגייס
Espírito Santo
CEDOES - Diagnóstico e Pesquisa, Vitória, Espírito Santo, 29055-450, Brazil
מגייס
Paraná
Instituto de Neurologia de Curitiba, Curitiba, Paraná, 81210-310, Brazil
מגייס
São Paulo
Centro de Pesquisas Clinicas, São Paulo, São Paulo, 01228-200, Brazil
מגייס
Hospital Israelita Albert Einstein, São Paulo, São Paulo, 05652-000, Brazil
מגייס
Beijing Children's Hospital, Capital Medical University, Beijing, 100045, China
מגייס
Beijing Tongren Hospital, Beijing, 100730, China
מגייס
Beijing Tiantan Hospital,Capital Medical University, Beijing, China
מגייס
The First Hospital of Jilin University, Changchun, 130021, China
מגייס
The Second Xiangya Hospital of Central South University, Changsha, 410011, China
מגייס
West China Hospital - Sichuan University, Chengdu, 610047, China
מגייס
Fujian Medical University Union Hospital, Fuzhou, 350001, China
מגייס
Guangzhou First Municipal People's Hospital, Guangzhou, 510180, China
מגייס
Affiliated Hospital of Jining Medical University, Jining, 272029, China
מגייס
Huashan Hospital, Fudan University, Shanghai, 200040, China
מגייס
The First Hospital of Shanxi Medical University, Taiyuan, 030001, China
מגייס
The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, 325035, China
הושלם
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, 430030, China
מגייס
Fakultni nemocnice Hradec Kralove, Hradec Králové, 500 05, Czechia
נסוג
Fakultni nemocnice v Motole, Prague, 150 06, Czechia
מגייס
Odense Universitetshospital, Neurologisk Afdeling N, Odense C, 5000, Denmark
מגייס
Hopital neurologique Pierre Wertheimer - CHU Lyon, Bron, 69677, France
הושלם
Hopital Pitié Salpétrière - CHU, Paris, 75651, France
מגייס
CHU Saint Etienne - Hôpital Nord, Saint-Etienne, 42055, France
נסוג
CHRU - Hôpital Bretonneau, Tours, 37000, France
מגייס
Komfo Anokye Teaching Hospital, Kumasi, Ghana
מגייס
Campania
A. O. U. Federico II, Naples, Campania, 80131, Italy
מגייס
AOU Seconda Università degli Studi, Naples, Campania, 80138, Italy
מגייס
Lazio
Ospedale Pediatrico Bambino Gesù, Rome, Lazio, 00165, Italy
נסוג
Liguria
Irccs A.O.U.San Martino Ist, Genoa, Liguria, 16132, Italy
מגייס
Lombardy
IRCCS Ospedale San Raffaele, Milan, Lombardy, 20132, Italy
מגייס
Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Lombardy, 20133, Italy
מגייס
Fondazione Istituto Neurologico Mondino IRCCS, Pavia, Lombardy, 27100, Italy
מגייס
Sicily
AOU Policlinico Giaccone, Palermo, Sicily, 90129, Italy
מגייס
Fujita Health University Hospital, Aichi, 470-1192, Japan
מגייס
Chiba University Hospital, Chiba, 260-8677, Japan
פעיל, לא מגייס
Kyushu University Hospital, Fukuoka, 812-8582, Japan
הושלם
Fukuoka University Hospital, Fukuoka, 814-0180, Japan
מגייס
Gifu University Hospital, Gifu, 501-1194, Japan
מגייס
Hokkaido University Hospital, Hokkaido, 060-8648, Japan
פעיל, לא מגייס
Hyogo prefectural Kobe Children's Hospital, Hyogoken, 6500047, Japan
מגייס
Kobe University Hospital, Hyōgo, 650-0017, Japan
מגייס
Kagoshima City Hospital, Kagoshima, 890-8760, Japan
מגייס
St.Marianna University School of Medicine hospital, Kanagawa, 216-8511, Japan
הושלם
Kitasato University Hospital, Kanagawa, 252-0375, Japan
פעיל, לא מגייס
Tokai University Hospital, Kanagawa, 259-1193, Japan
מגייס
Tohoku University Hospital, Miyagi, 980-8574, Japan
מגייס
The University of Osaka Hospital, Osaka, 565-0871, Japan
מגייס
Kindai University Hospital, Osaka, 590-0197, Japan
מגייס
Ageo Central General Hospital, Saitama, 362-8588, Japan
מגייס
Juntendo University Hospital, Tokyo, 113-8431, Japan
מגייס
Nihon University Itabashi Hospital, Tokyo, 173-8610, Japan
מגייס
Erasmus MC, Rotterdam, 3015 GD, Netherlands
מגייס
Regionalny Szpital Specjalistyczny im. W. Bieganskiego, Grudzi?dz, 86-300, Poland
נסוג
Szpital Uniwersytecki w Krakowie, Krakow, 30-688, Poland
הושלם
Instytut Psychiatrii i Neurologii II Klinika Neurologiczna, Warsaw, 02-957, Poland
מגייס
SPSK nr 1, Zabrze, 41-800, Poland
מגייס
National University Hospital (NUH), Singapore, 117599, Singapore
מגייס
Seoul National University Hospital, Seoul, 03080, South Korea
מגייס
Pontevedra
Hospital Alvaro Cunqueiro, Vigo, Pontevedra, DUMMY_VALUE, Spain
מגייס
Hospital General Universitario Gregorio Marañon, Madrid, 28007, Spain
מגייס
Hospital Regional Universitario de Malaga ? Hospital General, Málaga, 29010, Spain
מגייס
Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City, 00833, Taiwan
מגייס
China Medical University Hospital, North Dist., 40402, Taiwan
נסוג
Chang Gung Memorial Hospital - Linkou, Taoyuan, 333, Taiwan
מגייס