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Clinical Trial NCT05503264 (Cielo) for NMDAR Autoimmune Encephalitis, LGI1 Autoimmune Encephalitis is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Hoffmann-La 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) Phase 3 152
Clinical Trial NCT05503264 (Cielo) is designed to study Treatment for NMDAR Autoimmune Encephalitis, LGI1 Autoimmune Encephalitis. It is a Phase 3 interventional study that is recruiting, having started on 27 September 2022, with plans to enroll 152 participants. Led by Hoffmann-La Roche, it is expected to complete by 14 December 2029. The latest data from ClinicalTrials.gov was last updated on 6 March 2026.
Brief Summary
The purpose of this study is to assess the efficacy, safety, PK, and PD of satralizumab in participants with NMDAR and LGI1 encephalitis.
Official Title
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
Conditions
NMDAR Autoimmune EncephalitisLGI1 Autoimmune EncephalitisOther Study IDs
- Cielo
- WN43174
- 2021-002395-39 (EudraCT Number)
- 2023-504226-18-00 (EU Study (CTIS) Number)
NCT ID Number
Start Date (Actual)
2022-09-27
Last Update Posted
2026-03-06
Completion Date (Estimated)
2029-12-14
Enrollment (Estimated)
152
Study Type
Interventional
PHASE
Phase 3
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
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...Show More |
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...Show More |
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...Show More |
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...Show More |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child, Adult, Older Adult
Minimum Age
12 Years
Eligible Sexes
All
- 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
Hoffmann-La Roche289 active studies to exploreChugai PharmaceuticalStudy Central Contact
Contact: Reference Study ID Number: WN43174, https://forpatients.roche.com/, 888-662-6728 (U.S.), [email protected]
Contact: Global Medical Information:, [email protected]
92 Study Locations in 18 Countries
Alabama
University of Alabama at Birmingham, Birmingham, Alabama, 35233, United States
Recruiting
California
UC San Diego, La Jolla, California, 92037, United States
Recruiting
Hoag Memorial Hospital, Newport Beach, California, 92658, United States
Recruiting
UCSF- Multiple Sclerosis Centre, San Francisco, California, 94158, United States
Recruiting
Colorado
University of Colorado, Aurora, Colorado, 80045, United States
Recruiting
District of Columbia
Childrens National Health Center, Washington D.C., District of Columbia, 20010, United States
Recruiting
Georgia
Children's Healthcare of Atlanta Center for Advanced Pediatrics, Atlanta, Georgia, 30329, United States
Recruiting
Iowa
University of Iowa Hospitals & Clinics, Iowa City, Iowa, 52242, United States
Recruiting
Maryland
University of Maryland Medical Center, Baltimore, Maryland, 21201, United States
Recruiting
Johns Hopkins Hospital, Baltimore, Maryland, 21205, United States
Recruiting
Massachusetts
Brigham and Women's Hospital Department of Neurology, Boston, Massachusetts, 02115, United States
Recruiting
Minnesota
Mayo Clinic - Rochester, Rochester, Minnesota, 55905, United States
Recruiting
New York
NYU-Langone Medical Center, New York, New York, 10016, United States
Recruiting
North Carolina
Duke University Medical Center, Durham, North Carolina, 27710, United States
Recruiting
Ohio
University Hospitals of Cleveland, Cleveland, Ohio, 44106, United States
Recruiting
Cleveland Clinic Foundation, Cleveland, Ohio, 44915, United States
Recruiting
Pennsylvania
Univ of Pennsylvania Med Ctr, Philadelphia, Pennsylvania, 19104, United States
Recruiting
Texas
University of Texas at Houston, Houston, Texas, 77030, United States
Recruiting
Washington
Swedish Neuroscience Institute, Seattle, Washington, 98122, United States
Withdrawn
Wisconsin
Medical College of Wisconsin, Milwaukee, Wisconsin, 53226, United States
Recruiting
Hospital Ramos Mejía, CABA, C1221ADC, Argentina
Active, not recruiting
Hospital Britanico, Ciudad Autonoma Bs As, C1280AEB, Argentina
Recruiting
Sanatorio del Sur S.A., San Miguel de Tucumán, T4000IDK, Argentina
Recruiting
Kepler Universitätsklinikum GmbH - Neuromed Campus, Linz, 4020, Austria
Recruiting
Medizinische Universität Wien, Vienna, 1090, Austria
Withdrawn
Ceará
Hospital Geral de Fortaleza, Fortaleza, Ceará, 60175-295, Brazil
Recruiting
Espírito Santo
CEDOES - Diagnóstico e Pesquisa, Vitória, Espírito Santo, 29055-450, Brazil
Recruiting
Paraná
Instituto de Neurologia de Curitiba, Curitiba, Paraná, 81210-310, Brazil
Recruiting
São Paulo
Centro de Pesquisas Clinicas, São Paulo, São Paulo, 01228-200, Brazil
Recruiting
Hospital Israelita Albert Einstein, São Paulo, São Paulo, 05652-000, Brazil
Recruiting
Beijing Children's Hospital, Capital Medical University, Beijing, 100045, China
Recruiting
Beijing Tongren Hospital, Beijing, 100730, China
Recruiting
Beijing Tiantan Hospital,Capital Medical University, Beijing, China
Recruiting
The First Hospital of Jilin University, Changchun, 130021, China
Recruiting
The Second Xiangya Hospital of Central South University, Changsha, 410011, China
Recruiting
West China Hospital - Sichuan University, Chengdu, 610047, China
Recruiting
Fujian Medical University Union Hospital, Fuzhou, 350001, China
Recruiting
Guangzhou First Municipal People's Hospital, Guangzhou, 510180, China
Recruiting
Affiliated Hospital of Jining Medical University, Jining, 272029, China
Recruiting
Huashan Hospital, Fudan University, Shanghai, 200040, China
Recruiting
The First Hospital of Shanxi Medical University, Taiyuan, 030001, China
Recruiting
The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, 325035, China
Completed
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, 430030, China
Recruiting
Fakultni nemocnice Hradec Kralove, Hradec Králové, 500 05, Czechia
Withdrawn
Fakultni nemocnice v Motole, Prague, 150 06, Czechia
Recruiting
Odense Universitetshospital, Neurologisk Afdeling N, Odense C, 5000, Denmark
Recruiting
Hopital neurologique Pierre Wertheimer - CHU Lyon, Bron, 69677, France
Completed
Hopital Pitié Salpétrière - CHU, Paris, 75651, France
Recruiting
CHU Saint Etienne - Hôpital Nord, Saint-Etienne, 42055, France
Withdrawn
CHRU - Hôpital Bretonneau, Tours, 37000, France
Recruiting
Komfo Anokye Teaching Hospital, Kumasi, Ghana
Recruiting
Hadassah University Hospital Ein Kerem, Jerusalem, 9112001, Israel
Recruiting
Tel Aviv Sourasky Medical Center, Tel Aviv, 6423906, Israel
Recruiting
Campania
A. O. U. Federico II, Naples, Campania, 80131, Italy
Recruiting
AOU Seconda Università degli Studi, Naples, Campania, 80138, Italy
Recruiting
Lazio
Ospedale Pediatrico Bambino Gesù, Rome, Lazio, 00165, Italy
Withdrawn
Liguria
Irccs A.O.U.San Martino Ist, Genoa, Liguria, 16132, Italy
Recruiting
Lombardy
IRCCS Ospedale San Raffaele, Milan, Lombardy, 20132, Italy
Recruiting
Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Lombardy, 20133, Italy
Recruiting
Fondazione Istituto Neurologico Mondino IRCCS, Pavia, Lombardy, 27100, Italy
Recruiting
Sicily
AOU Policlinico Giaccone, Palermo, Sicily, 90129, Italy
Recruiting
Fujita Health University Hospital, Aichi, 470-1192, Japan
Recruiting
Chiba University Hospital, Chiba, 260-8677, Japan
Active, not recruiting
Kyushu University Hospital, Fukuoka, 812-8582, Japan
Completed
Fukuoka University Hospital, Fukuoka, 814-0180, Japan
Recruiting
Gifu University Hospital, Gifu, 501-1194, Japan
Recruiting
Hokkaido University Hospital, Hokkaido, 060-8648, Japan
Active, not recruiting
Hyogo prefectural Kobe Children's Hospital, Hyogoken, 6500047, Japan
Recruiting
Kobe University Hospital, Hyōgo, 650-0017, Japan
Recruiting
Kagoshima City Hospital, Kagoshima, 890-8760, Japan
Recruiting
St.Marianna University School of Medicine hospital, Kanagawa, 216-8511, Japan
Completed
Kitasato University Hospital, Kanagawa, 252-0375, Japan
Active, not recruiting
Tokai University Hospital, Kanagawa, 259-1193, Japan
Recruiting
Tohoku University Hospital, Miyagi, 980-8574, Japan
Recruiting
The University of Osaka Hospital, Osaka, 565-0871, Japan
Recruiting
Kindai University Hospital, Osaka, 590-0197, Japan
Recruiting
Ageo Central General Hospital, Saitama, 362-8588, Japan
Recruiting
Juntendo University Hospital, Tokyo, 113-8431, Japan
Recruiting
Nihon University Itabashi Hospital, Tokyo, 173-8610, Japan
Recruiting
Erasmus MC, Rotterdam, 3015 GD, Netherlands
Recruiting
Regionalny Szpital Specjalistyczny im. W. Bieganskiego, Grudzi?dz, 86-300, Poland
Withdrawn
Szpital Uniwersytecki w Krakowie, Krakow, 30-688, Poland
Completed
Instytut Psychiatrii i Neurologii II Klinika Neurologiczna, Warsaw, 02-957, Poland
Recruiting
SPSK nr 1, Zabrze, 41-800, Poland
Recruiting
National University Hospital (NUH), Singapore, 117599, Singapore
Recruiting
Seoul National University Hospital, Seoul, 03080, South Korea
Recruiting
Pontevedra
Hospital Alvaro Cunqueiro, Vigo, Pontevedra, DUMMY_VALUE, Spain
Recruiting
Hospital General Universitario Gregorio Marañon, Madrid, 28007, Spain
Recruiting
Hospital Regional Universitario de Malaga ? Hospital General, Málaga, 29010, Spain
Recruiting
Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City, 00833, Taiwan
Recruiting
China Medical University Hospital, North Dist., 40402, Taiwan
Withdrawn
Chang Gung Memorial Hospital - Linkou, Taoyuan, 333, Taiwan
Recruiting