🏛️ Verified NIH Record • Updated 2025-06-30

The ExTINGUISH Trial of Inebilizumab in NMDAR Encephalitis (NCT04372615)

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

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: University of Utah

🩺 Plain-English Summary (8th-Grade Level)

Determine the difference in the modified Rankin score at 16 weeks in participants with anti-N-methyl-D-aspartate receptor (NMDAR) encephalitis treated with "first-line" immunomodulatory therapies provided as standard-of-care, and either inebilizumab (investigational agent) or placebo.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (25 items) and avoid the listed exclusions (31 items).

Location: University of Alabama at Birmingham — Birmingham, Alabama

Age range: 12 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria Any of the following excludes an individual from participation in the study:
  • Any condition that, in the opinion of the Investigator, would interfere with the evaluation or administration of the IP, 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.
  • History of solid organ or cell-based transplantation. <!-- -->
  • 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 longer, prior to randomization.
  • Lactating or pregnant individuals, or individuals who intend to become pregnant anytime from study enrollment to 12 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.
  • Receipt of the following at any time prior to randomization: a. Alemtuzumab b. Total lymphoid irradiation c. Bone marrow transplant d. T-cell vaccination therapy
  • Receipt of any biologic B cell-depleting therapy (e.g., rituximab, ocrelizumab, obinutuzumab, ofatumumab, inebilizumab) in the 6 months prior to screening. Receipt of such a B cell-depleting agent in the period 6-12 months prior to screening is exclusionary unless B cell counts have returned to ≥ age-based LLN by central laboratory. For EU participants, B cell counts at screening will be determined by the laboratories of the participating sites. Receipt of non-depleting B cell-directed therapy (e.g., belimumab), abatacept, or other biologic immunomodulatory agent within 6 months prior screening.
  • Treatment at therapeutic doses/durations with any of the following within 3 months prior to randomization a. Natalizumab (Tysabri®) b. Cyclosporine c. Methotrexate d. Mitoxantrone e. Cyclophosphamide\* f. Azathioprine g. Mycophenolate mofetil \*Cyclophosphamide is only permitted as rescue therapy to be administered as outlined in Section 5.4.1 no earlier than the week 6 visit.
  • Severe drug allergic history or anaphylaxis to two or more food products or medicines (including known sensitivity to acetaminophen/paracetamol, diphenhydramine (cetirizine in EU) 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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (39 Sites)

Showing the first 25 of 39 sites.

  • University of Alabama at Birmingham — Birmingham, Alabama
  • St. Joseph Hospital and Medical Center Barrow Neurological Institute — Phoenix, Arizona
  • Mayo Clinic in Arizona — Scottsdale, Arizona
  • Children's Hospital of Orange County — Orange, California
  • UC Irvine — Orange, California
  • UC Davis — Sacramento, California
  • Children's Hospital Colorado Main Campus — Aurora, Colorado
  • University of Colorado — Aurora, Colorado
  • Yale University — New Haven, Connecticut
  • Mayo Clinic Jacksonville — Jacksonville, Florida
  • University of Miami — Miami, Florida
  • Emory University — Atlanta, Georgia
  • Ann and Robert H. Lurie Childrens Hospital of Chicago — Chicago, Illinois
  • Northwestern University Feinberg School of Medicine — Chicago, Illinois
  • University of Iowa — Iowa City, Iowa
  • Massachusetts General Hospital — Boston, Massachusetts
  • University of Michigan Health System — Ann Arbor, Michigan
  • Mayo Clinic Rochester — Rochester, Minnesota
  • Washington University in St. Louis School of Medicine — St Louis, Missouri
  • SUNY Downstate — Brooklyn, New York
  • Mount Sinai — New York, New York
  • Columbia University Medical Center — New York, New York
  • University of Rochester — Rochester, New York
  • SUNY Buffalo — Williamsville, New York
  • Wake Forest University Health Sciences — Winston-Salem, North Carolina

📞 Contact the Study Coordinator

Phone: (801) 585-7575

Email: stacey.clardy@hsc.utah.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Autoimmune Encephalitis clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗