The ExTINGUISH Trial of Inebilizumab in NMDAR Encephalitis

Conditions

• Autoimmune Encephalitis
• Encephalitis

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Inebilizumab — DRUG
  RCP: Blinded treatment on Day 1, Day 15, * Inebilizumab group: Inebilizumab 300 mg intravenous (IV) * Placebo group: IV matching placebo Prior to enrollment, all participants will receive standard of care, including high-dose corticosteroids (minimum of 3 days of treatment, 1 g methylprednisolone daily or equivalent) AND either IVIg (total dose range between 1.2 and 2 g/kg) OR plasmapheresis (defined as 5 or 6 exchanges). 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).
• Placebo — DRUG
  The placebo group will receive IV matching placebo on Day 1 and Day 15,

Study Details

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.

Key Dates

Start date

Mar 30, 2022

Status verified

Jun 2025

Primary completion

Sep 30, 2028

Completion

Sep 30, 2028

Study Design

Enrollment

116 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.
• 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.

Primary Outcome Measure

Change of modified Rankin score at 16 weeks [ Time Frame: 16 weeks ]

Central Contacts

• Stacey L Clardy, MD, PhD
  8015857575
  [email protected]
• Ka-Ho Wong, MBA
  8015857575
  [email protected]

Locations (35)

Find similar trials in Birmingham, AL

Related Studies

• CoMind Early Feasibility Study
  Recruiting · CoMind Technologies Limited · Sacramento, California
• Unhide® Project: A Digital Health Platform to Collect Lifestyle Data for Brain Inflammation Research
  Recruiting · Brain Inflammation Collaborative · Delafield, Wisconsin