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Tests treatment safety and results for Anti-N-Methyl-D-Aspartate Receptor Encephalitis
Official title Safety and Efficacy of Combined B Cell Depleting theRapy And Daratumumab In Autoimmune Encephalitis
ClinicalTrials.gov ID: NCT06867991
What this study is testing
What is Ofatumumab combined with daratumumab?
Ofatumumab combined with daratumumab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for anti-n-methyl-d-aspartate receptor encephalitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Autoimmune encephalitis is an autoimmune disease of the central nervous system that targets neuronal autoantigens. Anti-neuronal autoantibodies are produced in patients, with anti-NMDAR antibody being the most common.Anti-NMDAR encephalitis can be severe and life-threatening.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- Aged 12 years and above
- Meet the diagnosis of autoimmune encephalitis and the target antigen is a neuronal surface antigen
- Have received at least 3 days of 500-1000mg high-dose methylprednisolone impulse treatment and IVIG (0.4g/kg/d for 5 consecutive days) or at least 5...
- mRS ≥ 3 points and neuropsychiatric manifestations inadequate to symptomatic treatment
- Informed consent or guardian signed informed consent
You likely can't join if
- Severe active or chronic infection in the opinion of the investigator.
- Concurrently/previously participated in another clinical study involving investigational therapy within 4 weeks or 5 published half-lives of the...
- Women who are lactating or pregnant, or intend to become pregnant at any time within six months from study enrollment to the last dose of study drug.
- Known history of allergy or reaction to any component of the investigational drug formulation, or history of allergic reaction after any biological...
- Any of the following at screening (one repeat test may be performed during the same screening period to confirm results prior to randomization)...
- Confirmed positive hepatitis B serology (hepatitis B surface antigen and core antigen) and/or positive hepatitis C PCR at screening.
See the full eligibility criteria
- Aged 12 years and above
- Meet the diagnosis of autoimmune encephalitis and the target antigen is a neuronal surface antigen
- Have received at least 3 days of 500-1000mg high-dose methylprednisolone impulse treatment and IVIG (0.4g/kg/d for 5 consecutive days) or at least 5 plasma exchange/immunoadsorption or at least 2 times of efgartigimod...
- mRS ≥ 3 points and neuropsychiatric manifestations inadequate to symptomatic treatment
- Informed consent or guardian signed informed consent
- Severe active or chronic infection in the opinion of the investigator.
- Concurrently/previously participated in another clinical study involving investigational therapy within 4 weeks or 5 published half-lives of the investigational therapy (whichever is longer) before randomization.
- Women who are lactating or pregnant, or intend to become pregnant at any time within six months from study enrollment to the last dose of study drug.
- Known history of allergy or reaction to any component of the investigational drug formulation, or history of allergic reaction after any biological treatment.
- Any of the following at screening (one repeat test may be performed during the same screening period to confirm results prior to randomization): Aspartate aminotransferase (AST) \> 2.5 × upper limit of normal (ULN)...
- Confirmed positive hepatitis B serology (hepatitis B surface antigen and core antigen) and/or positive hepatitis C PCR at screening.
- History of cancer, other than ovarian or extraovarian teratoma (also known as dermoid cyst) or germ cell tumor, or cutaneous squamous cell carcinoma or cutaneous basal cell carcinoma. Treatment of squamous cell...
- Received any live or attenuated vaccine (inactivated vaccine is acceptable) within 3 weeks before enrollment.
- Received BCG vaccine within 1 year before enrollment.
The study team makes the final eligibility decision.
Where it's taking place
- Zhengzhou, Henan, China
- Changzhou, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhengzhou, Henan, China; Changzhou, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.