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

ConditionAutoimmune Encephalitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJena University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinically diagnosed severe autoimmune encephalitis (defined as mRS ≥ 3) with autoantibodies to neuronal surface proteins in cerebrospinal fluid and / or serum

Pretreatment with rituximab

Age ≥18 years

signed informed consent

Disqualifiers

pregnancy/breast-feeding

acute infiltrative pulmonary and pericardial disease

malignant tumor under current chemotherapy

Simultaneous participation in another intervention study

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bortezomib

    Drug

    1 to 3 cycles Bortezomib with 1,3mg/m2 body surface s.c. + 20mg dexamethasone p.o. on days 1, 4, 8 and 11 (= 1 cycle)

  • Placebo

    Drug

    1 to 3 cycles placebo (NaCl solution) s.c. + 20mg dexamethasone p.o. on days 1, 4, 8 and 11 (= 1 cycle)

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: InterventionalExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

modified Rankin-Score (mRS)

modified Rankin-Score from 0 = no symptoms to 6 = death

Time frame
17 weeks after first administration of the study drug

Secondary outcomes

1

modified Rankin-Score (mRS)

modified Rankin-Score from 0 = no symptoms to 6 = death

Time frame
3, 6, 9 and 13 weeks after first administration of the study drug; GCS Score also 17 weeks after first administration of the study drug
2

Length of in-hospital stay / length of ICU stay

Number of days in hospital or on ICU for each patient from first administration of the study drug until 17 weeks after first administration of the study drug

Time frame
until 17 weeks after first administration of the study drug
3

Immune response

Antibody titer (in serum and liquor) and cellular immune response (FACS analysis of liquor)

Time frame
at study start and 17 weeks after first administration of the study drug
4

neurocognitive function assessed by Montreal Cognitive Assessment

total score of the Montreal Cognitive Assessment (MoCA) (0 to max. 30 points = best possible result)

Time frame
at study start and 17 weeks after first administration of the study medication

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jena University Hospital

Lead sponsor

Federal Ministry of Education and Reserach (BMBF)

Collaborator

Source ClinicalTrials.gov
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