RECRUITING

The ExTINGUISH Trial of Inebilizumab in NMDAR Encephalitis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-03-30
Study Completion:2026-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04372615

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Stacey L Clardy, MD, PhD
CONTACT
8015857575
stacey.clardy@hsc.utah.edu
Ka-Ho Wong, MBA
CONTACT
8015857575
ka-ho.wong@hsc.utah.edu

Principal Investigator

Stacey L Clardy, MD, PhD
PRINCIPAL_INVESTIGATOR
University of Utah

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35233
United States
St. Joseph Hospital and Medical Center Barrow Neurological Institute
Phoenix, Arizona, 85013
United States
UC Irvine
Orange, California, 92868
United States
UC Davis
Sacramento, California, 95816
United States
Yale University
New Haven, Connecticut, 06510
United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
United States
University of Miami
Miami, Florida, 33136
United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
United States
University of Iowa
Iowa City, Iowa, 52242
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
University of Michigan Health System
Ann Arbor, Michigan, 48109
United States
Washington University in St. Louis School of Medicine
Saint Louis, Missouri, 63110
United States
SUNY Downstate
Brooklyn, New York, 11203
United States
Mount Sinai
New York, New York, 10029
United States
Columbia University Medical Center
New York, New York, 10033
United States
University of Rochester
Rochester, New York, 14618
United States
SUNY Buffalo
Williamsville, New York, 14221
United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27101
United States
University of Cincinnati
Cincinnati, Ohio, 45219
United States
Ohio State University
Columbus, Ohio, 43210
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
Vanderbilt University
Nashville, Tennessee, 37212
United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States
University of Utah
Salt Lake City, Utah, 84108
United States
University of Virginia
Charlottesville, Virginia, 22903
United States

Collaborators and Investigators

Sponsor: University of Utah

  • Stacey L Clardy, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Utah

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-30
Study Completion Date2026-08-31

Study Record Updates

Study Start Date2022-03-30
Study Completion Date2026-08-31

Terms related to this study

Keywords Provided by Researchers

  • Inebilizumab
  • NMDAR encephalitis
  • Autoimmune Encephalitis
  • Rare Disease

Additional Relevant MeSH Terms

  • Autoimmune Encephalitis
  • Encephalitis