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Trial to Evaluate Efficacy and Safety of Bortezomib in Patients With Severe Autoimmune Encephalitis

Study acronym: Generate-Boost
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 4, 2025 (before its estimated September 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Nov 30, 2025 to Sep 30, 2026
    • Study completion date: Apr 30, 2026 to Dec 31, 2026
    v13
  2. Collaborators expanded, about 7 wordsv12
  3. Site details revised at 4 of 17 sitesv11
  4. Primary completion date: Mar 1, 2024 to Nov 30, 2025
    • Study sites: 14 to 17
    • Study completion date: Oct 31, 2024 to Apr 30, 2026
    v10
  5. Primary completion date: Mar 1, 2023 to Mar 1, 2024
    • Study completion date: Oct 31, 2023 to Oct 31, 2024
    v9
Show 7 earlier versionsHide 7 earlier versions
  1. Primary completion date: Jul 1, 2022 to Mar 1, 2023
    • Study completion date: Jul 31, 2023 to Oct 31, 2023
    v8
  2. Study sites: 12 to 14
    • Study completion date: Dec 31, 2022 to Jul 31, 2023
    v7
  3. Study sites: 13 to 12v6
  4. Study sites: 10 to 13
    • Eligibility criteria expanded, about 65 words
    v5
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 1, 2020 to May 13, 2020
    • Study sites: 8 to 10
    v4
  6. Study sites: 5 to 8v3
  7. Start date: Oct 1, 2019 to Feb 1, 2020
    • Study sites: 1 to 5
    • Secondary endpoints: 13 to 18
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Autoimmune Encephalitis is a disorder of the central nervous system caused by bodily substances, called antibodies. Antibodies normally help the body to prevent infections. However, in this disorder, the antibodies turn against the body itself and especially against cells in the brain and disturb the normal brain function. They are therefore called autoantibodies. There is no specific therapy for patients with autoimmune encephalitis so far. At the moment, the symptoms are treated with approved medications such as cortisone and immunotherapies also used in oncology. These therapies are unspecified and aim to reduce the number of autoantibodies and to contain the autoimmune process. In this trial we aim to test a new therapy option: in this therapy the body cells producing autoantibodies will be specifically targeted by a substance called bortezomib. The trial addresses patients with severe autoimmune encephalitis. The aim of the trial is to evaluate the efficacy and safety of bortezomib in patients with severe autoimmune encephalitis.
Trial Details
NCT Number NCT03993262
Lead Sponsor Jena University Hospital
Collaborators: Federal Ministry of Education and Reserach (BMBF)
Conditions
(from sponsor)		 Autoimmune Encephalitis
Related terms Autoimmune Diseases, Autoimmune Diseases of the Nervous System, Encephalitis
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov