- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04372615
The ExTINGUISH Trial of Inebilizumab in NMDAR Encephalitis (ExTINGUISH)
A Phase-2b, Double-Blind, Randomized Controlled Trial to Evaluate the Activity and Safety of Inebilizumab in Anti-Nmda Receptor Encephalitis and Assess Markers of Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Stacey L Clardy, MD, PhD
- Phone Number: 8015857575
- Email: stacey.clardy@hsc.utah.edu
Study Contact Backup
- Name: Ka-Ho Wong, MBA
- Phone Number: 8015857575
- Email: ka-ho.wong@hsc.utah.edu
Study Locations
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Rotterdam, Netherlands
- Not yet recruiting
- Erasmus Medical University Center
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Contact:
- Wendy Hamerslag-de Groot
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Principal Investigator:
- Maarten Titulaer, MD
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Barcelona, Spain
- Not yet recruiting
- Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), University of Barcelona
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Contact:
- Dalmau Josep
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Principal Investigator:
- Josep Dalmau
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Alabama
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Birmingham, Alabama, United States, 35233
- Recruiting
- University of Alabama at Birmingham
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Contact:
- Melanie Benge
- Email: melaniebenge@uabmc.edu
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Principal Investigator:
- Louis Nabors
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Arizona
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Phoenix, Arizona, United States, 85013
- Recruiting
- St. Joseph Hospital and Medical Center Barrow Neurological Institute
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Contact:
- Mary Thornton
- Phone Number: 602-406-6287
- Email: mary.thornton@dignityhealth.org
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Principal Investigator:
- Michael Robers, MD
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California
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Orange, California, United States, 92868
- Recruiting
- UC Irvine
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Contact:
- Isela Hernandez
- Phone Number: 714-509-2664
- Email: iselah@uci.edu
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Principal Investigator:
- Xiao-Tang Kong, MD
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Sacramento, California, United States, 95816
- Recruiting
- UC Davis
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Contact:
- Lynea Kaethler
- Phone Number: 916-734-3993
- Email: lbkaethler@ucdavis.edu
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Contact:
- Erica Goude
- Phone Number: 916-734-0384
- Email: emgoude@ucdavis.edu
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Principal Investigator:
- Mustafa Ansari, MD
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Connecticut
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New Haven, Connecticut, United States, 06510
- Recruiting
- Yale University
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Contact:
- Danielle Paquette
- Email: danielle.paquette@yale.edu
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Principal Investigator:
- Erin Longbrake, MD
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Florida
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Jacksonville, Florida, United States, 32224
- Recruiting
- Mayo Clinic Jacksonville
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Contact:
- Pamela Desaro
- Phone Number: 904-953-7720
- Email: Desaro.Pamela@mayo.edu
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Principal Investigator:
- Gregory Day, MD
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Miami, Florida, United States, 33136
- Not yet recruiting
- University of Miami
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Contact:
- Julie Steele
- Phone Number: 305-775-9502
- Email: jsteele@med.miami.edu
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Contact:
- Danielle Bass
- Phone Number: 305-243-6320
- Email: dhb55@med.miami.edu
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Principal Investigator:
- Ayham Alkhachroum
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Illinois
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Chicago, Illinois, United States, 60611
- Recruiting
- Northwestern University Feinberg School of Medicine
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Contact:
- Monika Szela
- Email: monika.szela@northwestern.edu
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Principal Investigator:
- Elena Grebenciucova, MD
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Iowa
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Iowa City, Iowa, United States, 52242
- Recruiting
- University of Iowa
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Contact:
- Loraine Brenner
- Phone Number: 319-356-4361
- Email: loraine-brenner@uiowa.edu
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Principal Investigator:
- Tracey Cho, MD
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Recruiting
- Massachusetts General Hospital
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Contact:
- Rina Dhawlikar
- Phone Number: 908-601-8967
- Email: rdhawlikar@mgh.harvard.edu
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Contact:
- Santiago Pardo
- Phone Number: 410-926-6248
- Email: SPARDO1@mgh.harvard.edu
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Principal Investigator:
- Michael Levy, MD
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Michigan
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Ann Arbor, Michigan, United States, 48109
- Recruiting
- University of Michigan Health System
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Contact:
- Amanda Rasnake
- Phone Number: 734-232-2452
- Email: arasnake@med.umich.edu
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Principal Investigator:
- Craig Williamson, MD
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Missouri
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Saint Louis, Missouri, United States, 63110
- Recruiting
- Washington University in St. Louis School of Medicine
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Contact:
- Mengesha Teshome
- Phone Number: 314-747-8420
- Email: teshomem@wustl.edu
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Principal Investigator:
- Steven Dunham, MD
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New York
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Brooklyn, New York, United States, 11203
- Not yet recruiting
- SUNY Downstate
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Contact:
- Nadege Gilles
- Phone Number: 718-270-7786
- Email: Nadege.Gilles@Downstate.edu
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Contact:
- Sofya Glazman
- Email: Sofya.Glazman@downstate.edu
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Principal Investigator:
- Yaacov Anziska
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New York, New York, United States, 10029
- Recruiting
- Mount Sinai
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Contact:
- Kevin Van Geem
- Phone Number: 347-804-3699
- Email: kevin.vangeem@mssm.edu
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Principal Investigator:
- Pojen Deng
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Sub-Investigator:
- Sammita Satyanarayan
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Sub-Investigator:
- Jiyeoun Yoo
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New York, New York, United States, 10033
- Recruiting
- Columbia University Medical Center
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Contact:
- Jennie Mata
- Email: jmm2220@cumc.columbia.edu
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Principal Investigator:
- Sarah Wesley, MD
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Rochester, New York, United States, 14618
- Recruiting
- University of Rochester
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Principal Investigator:
- Andrew Goodman, MD
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Contact:
- Christine Anne
- Phone Number: 585-276-3037
- Email: Christine_annis@urmc.rochester.edu
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Williamsville, New York, United States, 14221
- Not yet recruiting
- SUNY Buffalo
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Contact:
- Kara Patrick
- Phone Number: 716-829-5037
- Email: kpatrick@buffalo.edu
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Contact:
- Annemarie Crumlish
- Phone Number: 716-829-5046
- Email: ac35@buffalo.edu
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Principal Investigator:
- Eckert Svetlana
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North Carolina
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Winston-Salem, North Carolina, United States, 27101
- Recruiting
- Wake Forest University Health Sciences
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Principal Investigator:
- Roy Strowd, MD
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Contact:
- Carolina Burgos
- Email: caguilar@wakehealth.edu
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Ohio
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Cincinnati, Ohio, United States, 45219
- Recruiting
- University of Cincinnati
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Principal Investigator:
- Aram Zabeti, MD
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Contact:
- Tiffany Rupert
- Phone Number: 513-558-0269
- Email: rupertts@ucmail.uc.edu
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Contact:
- Angela Molloy
- Phone Number: 513-558-7118
- Email: angela.molloy@uc.edu
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Columbus, Ohio, United States, 43210
- Recruiting
- Ohio State University
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Contact:
- Casey Mitchell
- Phone Number: 614-685-9906
- Email: casey.mitchell@osumc.edu
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Contact:
- Marina Rodriguez
- Phone Number: 614-366-2840
- Email: marina.rodriguez@osumc.edu
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Principal Investigator:
- Tirisham Gyang
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Sub-Investigator:
- Allison Jordan
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- University of Pennsylvania
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Principal Investigator:
- Eric Lancaster, MD
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Contact:
- Priyanka Kalyani
- Phone Number: 215-820-2726
- Email: Priyanka.Kalyani@Pennmedicine.upenn.edu
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Pittsburgh, Pennsylvania, United States, 15213
- Recruiting
- University of Pittsburgh
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Contact:
- Dane Prince
- Phone Number: 262-490-6818
- Email: princede2@upmc.edu
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Contact:
- Kerry Oddis
- Phone Number: 412-692-4918
- Email: kmoddis@upmc.edu
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Principal Investigator:
- Lori Shutter
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Tennessee
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Nashville, Tennessee, United States, 37212
- Recruiting
- Vanderbilt University
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Contact:
- Ryann Gardner
- Phone Number: 615-322-4085
- Email: ryann.gardner@vumc.org
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Contact:
- Kehaunani Hubbard
- Phone Number: 615-322-4322
- Email: kehaunani.m.hubbard@vumc.org
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Principal Investigator:
- Siddharama Pawate, MD
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Texas
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Dallas, Texas, United States, 75390
- Recruiting
- University of Texas Southwestern Medical Center
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Contact:
- Amy Conger
- Phone Number: 214-645-8208
- Email: amy.conger@utsouthwestern.edu
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Principal Investigator:
- Kyle Blackburn, MD
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Utah
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Salt Lake City, Utah, United States, 84108
- Recruiting
- University of Utah
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Contact:
- Ka-Ho Wong, MBA
- Phone Number: 8015857575
- Email: ka-ho.wong@hsc.utah.edu
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Contact:
- Stacey L Clardy, MD, PhD
- Phone Number: 801-585-7575
- Email: stacey.clardy@hsc.utah.edu
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Principal Investigator:
- Stacey Clardy
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Virginia
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Charlottesville, Virginia, United States, 22903
- Recruiting
- University of Virginia
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Contact:
- Kay Maupin
- Phone Number: 434-982-6961
- Email: klm8a@hscmail.mcc.virginia.edu
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Principal Investigator:
- Meena Kannan, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Inclusion Criteria 1. Diagnosis of NMDAR encephalitis, defined by both (a) and (b):
- A subacute onset of change in mental status consistent with autoimmune encephalitis,
A positive cell-based assay for anti-NMDA receptor IgG antibody in the CSF confirmed in study-specified laboratories.
2. Age ≥ 18 years 3. Written informed consent and any locally required authorization (e.g., Health Insurance Portability and Accountability Act [HIPAA] in the United States of America (USA), European Union [EU] Data Privacy Directive in the EU) obtained from the participant/legal representative prior to performing any protocol-related procedures, including screening evaluations.
4. Females of childbearing potential who are sexually active with a nonsterilized male partner must agree to use a highly effective method of contraception beginning at screening or upon discharge from hospitalization/inpatient rehabilitation (for participants who were incapacitated at the time of screening), and to continue precautions for 6 months after the final dose of investigational product.
5. Nonsterilized males who are sexually active with a female partner of childbearing potential must agree to use a highly effective method of contraception at screening or upon discharge from hospitalization/inpatient rehabilitation (for participants who were incapacitated at the time of screening), and to continue precautions for 3 months after the final dose of investigational product. Male patients with female partners of childbearing potential must have that female partner use at least one form of highly effective contraception, starting at least one menstrual cycle before (the male patient's) first study drug administration and continuing until at least 3 months after their male partner's last dose of the study drug.
6. Willing to forego other immunomodulatory therapies (investigational or otherwise) for NMDAR encephalitis during the study.
7. Patient must have received at least 3 days of methylprednisolone 1000 mg IV or equivalent corticosteroid within 30 days prior to randomization (Day 1). In addition, patients must have received EITHER of the following treatments within 30 days before randomization.
- IVIg, at a minimum dose of 2 g/kg
Plasma exchange or plasmapheresis, with a minimum of 5 treatments. NOTE: These treatments may be provided during the screening period, but must be completed prior to randomization.
8. mRS of ≥3 at the screening visit, indicating at least moderate disability. 9. Ability and willingness to attend study visits and complete the study
Exclusion Criteria:
- Any condition that, in the opinion of the investigator, would interfere with the evaluation or administration of the investigational product, interpretation of participant safety or study results, or would make participation in the study an unacceptable risk. This specifically includes recent history (last 5 years) of herpes simplex virus encephalitis or known central nervous system demyelinating disease (e.g., multiple sclerosis).
- Presence of an active or chronic infection that is serious in the opinion of the investigator.
- Concurrent/previous enrollment in another clinical study involving an investigational treatment within 4 weeks or 5 published half-lives of the investigational treatment, whichever is the longer, prior to randomization.
- Lactating or pregnant females, or females who intend to become pregnant anytime from study enrollment to 6 months following last dose of investigational agent.
- Known history of allergy or reaction to any component of the investigational agent formulation or history of anaphylaxis following any biologic therapy.
At screening (one repeat test may be conducted to confirm results prior to randomization within the same screening period), any of the following:
- Aspartate transaminase (AST) > 2.5 × upper limit of normal (ULN)
- Alanine transaminase (ALT) > 2.5 × upper limit of normal (ULN)
- Total bilirubin > 1.5 × ULN (unless due to Gilbert's syndrome)
- Platelet count < 75,000/μL (or < 75 × 109/L)
- Hemoglobin < 8 g/dL (or < 80 g/L)
- Total white blood count <2,500 cells/mm3
- Total immunoglobulin < 600 mg/dL
- Absolute neutrophil count < 1200 cells/μL
- CD4 T lymphocyte count < 300 cells/µL
Receipt of the following at any time prior to randomization:
- Alemtuzumab
- Total lymphoid irradiation
- Bone marrow transplant
- T-cell vaccination therapy
- Receipt of rituximab or any experimental B-cell depleting agent, unless the CD19 B-cell level has returned to above the lower limit of normal prior to randomization.
Receipt of any of the following within 3 months prior to randomization
- Natalizumab (Tysabri®)
- Cyclosporine
- Methotrexate
- Mitoxantrone
- Cyclophosphamide
- Azathioprine
- Mycophenolate mofetil
- Severe drug allergic history or anaphylaxis to two or more food products or medicines (including known sensitivity to acetaminophen/paracetamol, diphenhydramine or equivalent antihistamine, and methylprednisolone or equivalent glucocorticoid).
- Known history of a primary immunodeficiency (congenital or acquired) or an underlying condition such as human immunodeficiency virus (HIV) infection or splenectomy that predisposes the participant to infection.
13. Confirmed positive test for hepatitis B serology (hepatitis B surface antigen and core antigen) and/or hepatitis C PCR positive at screening.
14. History of cancer, apart from ovarian or extra-ovarian teratoma (also known as a dermoid cyst) or germ cell tumor, or squamous cell carcinoma of the skin or basal cell carcinoma of the skin. Squamous cell and basal cell carcinomas should be treated with documented success of curative therapy > 3 months prior to randomization.
15. Any live or attenuated vaccine within 3 weeks prior to Day 1 (administration of killed vaccines is acceptable).
16. Bacillus of Calmette and Guérin (BCG) vaccine within 1 year of enrollment. 17. Recurrence of previously treated NMDAR encephalitis within the last 3 or 5 years, or suspicion of symptomatic untreated NMDAR encephalitis of greater than 3 months duration at the time of screening.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Inebilizumab
Approximately 58 patients will receive Inebilizumab in addition to first line immunotherapy. (Approximately 116 participants will be randomized in a 1:1 ratio to 2 treatment groups; approximately 58 participants to each treatment group). All participants will also receive a 3 day course of IVIg. |
RCP: Blinded treatment on Day 1, Day 15,
Rescue therapy will be given to participants in either treatment group based on the results of the Week 6 assessments. Rescue therapy is cyclophosphamide 750 mg/m2 IV followed by additional doses every 28-30 days until the mRS score is ≤ 3 (at site Principal Investigator's discretion under standard of care).
Other Names:
|
Placebo Comparator: Placebo
Approximately 58 patients will receive placebo in addition to first line immunotherapy. (Approximately 116 participants will be randomized in a 1:1 ratio to 2 treatment groups; approximately 58 participants to each treatment group). All participants will also receive a 3 day course of IVIg. |
The placebo group will receive IV matching placebo on Day 1 and Day 15,
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of modified Rankin score at 16 weeks
Time Frame: 16 weeks
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Change in modified Rankin score (mRS) (0 to 6; 0=normal and 6=death) at 16 weeks determined by rank analyses, integrating need for rescue therapy and time to achievement of the mRS.
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16 weeks
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Inebilizumab safety measures by the number of treatment-emergent adverse events and serious adverse events
Time Frame: 96 weeks
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Inebilizumab safety, as measured by the number of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)
|
96 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to mRS ≤ 2, corrected for baseline value.
Time Frame: 96 weeks
|
Time to mRS ≤ 2, corrected for baseline value.
|
96 weeks
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Clinical Assessment Scale in Autoimmune Encephalitis (CASE) Score (continuous logistic regression), corrected from baseline value to week 24 (weeks 6 and 16).
Time Frame: 16 weeks
|
Clinical Assessment Scale in Autoimmune Encephalitis (CASE) Score (ranges of 0 to 27 with 0 being normal and 27 being worse)(continuous logistic regression), corrected from baseline value to week 24 (weeks 6 and 16).
|
16 weeks
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mRS at week 6 as measured by proportional odds logistic regression/shift analysis.
Time Frame: 6 weeks
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mRS at week 6 as measured by proportional odds logistic regression/shift analysis.
|
6 weeks
|
Proportion of participants who meet the protocol-defined criteria for needing rescue therapy at week 6.
Time Frame: 6 weeks
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Proportion of participants who meet the protocol-defined criteria for needing rescue therapy at week 6.
|
6 weeks
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Cognitive outcome at week 24 as measured by mean scaled score on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) + components of Delis-Kaplan Executive Function System (D-KEFS).
Time Frame: 24 weeks
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Cognitive outcome at week 24 as measured by mean scaled score on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) + components of Delis-Kaplan Executive Function System (D-KEFS).
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24 weeks
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Survival as measured by a Kaplan-Meier analysis.
Time Frame: 96 weeks
|
Survival as measured by a Kaplan-Meier analysis.
|
96 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stacey L Clardy, MD, PhD, University of Utah
Publications and helpful links
General Publications
- Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x. Erratum In: J Am Geriatr Soc. 2019 Sep;67(9):1991.
- Titulaer MJ, McCracken L, Gabilondo I, Armangue T, Glaser C, Iizuka T, Honig LS, Benseler SM, Kawachi I, Martinez-Hernandez E, Aguilar E, Gresa-Arribas N, Ryan-Florance N, Torrents A, Saiz A, Rosenfeld MR, Balice-Gordon R, Graus F, Dalmau J. Treatment and prognostic factors for long-term outcome in patients with anti-NMDA receptor encephalitis: an observational cohort study. Lancet Neurol. 2013 Feb;12(2):157-65. doi: 10.1016/S1474-4422(12)70310-1. Epub 2013 Jan 3.
- Gabilondo I, Saiz A, Galan L, Gonzalez V, Jadraque R, Sabater L, Sans A, Sempere A, Vela A, Villalobos F, Vinals M, Villoslada P, Graus F. Analysis of relapses in anti-NMDAR encephalitis. Neurology. 2011 Sep 6;77(10):996-9. doi: 10.1212/WNL.0b013e31822cfc6b. Epub 2011 Aug 24.
- Dalmau J, Tuzun E, Wu HY, Masjuan J, Rossi JE, Voloschin A, Baehring JM, Shimazaki H, Koide R, King D, Mason W, Sansing LH, Dichter MA, Rosenfeld MR, Lynch DR. Paraneoplastic anti-N-methyl-D-aspartate receptor encephalitis associated with ovarian teratoma. Ann Neurol. 2007 Jan;61(1):25-36. doi: 10.1002/ana.21050.
- Dubey D, Pittock SJ, Kelly CR, McKeon A, Lopez-Chiriboga AS, Lennon VA, Gadoth A, Smith CY, Bryant SC, Klein CJ, Aksamit AJ, Toledano M, Boeve BF, Tillema JM, Flanagan EP. Autoimmune encephalitis epidemiology and a comparison to infectious encephalitis. Ann Neurol. 2018 Jan;83(1):166-177. doi: 10.1002/ana.25131.
- Dalmau J, Gleichman AJ, Hughes EG, Rossi JE, Peng X, Lai M, Dessain SK, Rosenfeld MR, Balice-Gordon R, Lynch DR. Anti-NMDA-receptor encephalitis: case series and analysis of the effects of antibodies. Lancet Neurol. 2008 Dec;7(12):1091-8. doi: 10.1016/S1474-4422(08)70224-2. Epub 2008 Oct 11.
- Gresa-Arribas N, Titulaer MJ, Torrents A, Aguilar E, McCracken L, Leypoldt F, Gleichman AJ, Balice-Gordon R, Rosenfeld MR, Lynch D, Graus F, Dalmau J. Antibody titres at diagnosis and during follow-up of anti-NMDA receptor encephalitis: a retrospective study. Lancet Neurol. 2014 Feb;13(2):167-77. doi: 10.1016/S1474-4422(13)70282-5. Epub 2013 Dec 18. Erratum In: Lancet Neurol. 2014 Feb;13(2):135.
- Guasp M, Modena Y, Armangue T, Dalmau J, Graus F. Clinical features of seronegative, but CSF antibody-positive, anti-NMDA receptor encephalitis. Neurol Neuroimmunol Neuroinflamm. 2020 Jan 3;7(2):e659. doi: 10.1212/NXI.0000000000000659. Print 2020 Mar.
- Dalmau J, Lancaster E, Martinez-Hernandez E, Rosenfeld MR, Balice-Gordon R. Clinical experience and laboratory investigations in patients with anti-NMDAR encephalitis. Lancet Neurol. 2011 Jan;10(1):63-74. doi: 10.1016/S1474-4422(10)70253-2.
- Cree BAC, Bennett JL, Kim HJ, Weinshenker BG, Pittock SJ, Wingerchuk DM, Fujihara K, Paul F, Cutter GR, Marignier R, Green AJ, Aktas O, Hartung HP, Lublin FD, Drappa J, Barron G, Madani S, Ratchford JN, She D, Cimbora D, Katz E; N-MOmentum study investigators. Inebilizumab for the treatment of neuromyelitis optica spectrum disorder (N-MOmentum): a double-blind, randomised placebo-controlled phase 2/3 trial. Lancet. 2019 Oct 12;394(10206):1352-1363. doi: 10.1016/S0140-6736(19)31817-3. Epub 2019 Sep 5.
- Hara M, Martinez-Hernandez E, Arino H, Armangue T, Spatola M, Petit-Pedrol M, Saiz A, Rosenfeld MR, Graus F, Dalmau J. Clinical and pathogenic significance of IgG, IgA, and IgM antibodies against the NMDA receptor. Neurology. 2018 Apr 17;90(16):e1386-e1394. doi: 10.1212/WNL.0000000000005329. Epub 2018 Mar 16.
- Warikoo N, Brunwasser SJ, Benz A, Shu HJ, Paul SM, Lewis M, Doherty J, Quirk M, Piccio L, Zorumski CF, Day GS, Mennerick S. Positive Allosteric Modulation as a Potential Therapeutic Strategy in Anti-NMDA Receptor Encephalitis. J Neurosci. 2018 Mar 28;38(13):3218-3229. doi: 10.1523/JNEUROSCI.3377-17.2018. Epub 2018 Feb 23.
- Hughes EG, Peng X, Gleichman AJ, Lai M, Zhou L, Tsou R, Parsons TD, Lynch DR, Dalmau J, Balice-Gordon RJ. Cellular and synaptic mechanisms of anti-NMDA receptor encephalitis. J Neurosci. 2010 Apr 28;30(17):5866-75. doi: 10.1523/JNEUROSCI.0167-10.2010.
- Tuzun E, Zhou L, Baehring JM, Bannykh S, Rosenfeld MR, Dalmau J. Evidence for antibody-mediated pathogenesis in anti-NMDAR encephalitis associated with ovarian teratoma. Acta Neuropathol. 2009 Dec;118(6):737-43. doi: 10.1007/s00401-009-0582-4.
- Matute C, Palma A, Serrano-Regal MP, Maudes E, Barman S, Sanchez-Gomez MV, Domercq M, Goebels N, Dalmau J. N-Methyl-D-Aspartate Receptor Antibodies in Autoimmune Encephalopathy Alter Oligodendrocyte Function. Ann Neurol. 2020 May;87(5):670-676. doi: 10.1002/ana.25699. Epub 2020 Feb 24.
- Planaguma J, Leypoldt F, Mannara F, Gutierrez-Cuesta J, Martin-Garcia E, Aguilar E, Titulaer MJ, Petit-Pedrol M, Jain A, Balice-Gordon R, Lakadamyali M, Graus F, Maldonado R, Dalmau J. Human N-methyl D-aspartate receptor antibodies alter memory and behaviour in mice. Brain. 2015 Jan;138(Pt 1):94-109. doi: 10.1093/brain/awu310. Epub 2014 Nov 11.
- Planaguma J, Haselmann H, Mannara F, Petit-Pedrol M, Grunewald B, Aguilar E, Ropke L, Martin-Garcia E, Titulaer MJ, Jercog P, Graus F, Maldonado R, Geis C, Dalmau J. Ephrin-B2 prevents N-methyl-D-aspartate receptor antibody effects on memory and neuroplasticity. Ann Neurol. 2016 Sep;80(3):388-400. doi: 10.1002/ana.24721. Epub 2016 Aug 2.
- Malviya M, Barman S, Golombeck KS, Planaguma J, Mannara F, Strutz-Seebohm N, Wrzos C, Demir F, Baksmeier C, Steckel J, Falk KK, Gross CC, Kovac S, Bonte K, Johnen A, Wandinger KP, Martin-Garcia E, Becker AJ, Elger CE, Klocker N, Wiendl H, Meuth SG, Hartung HP, Seebohm G, Leypoldt F, Maldonado R, Stadelmann C, Dalmau J, Melzer N, Goebels N. NMDAR encephalitis: passive transfer from man to mouse by a recombinant antibody. Ann Clin Transl Neurol. 2017 Oct 3;4(11):768-783. doi: 10.1002/acn3.444. eCollection 2017 Nov.
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Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 143461
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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