Phase 3: testing Ofatumumab combined with daratumumab for Anti-N-Methyl-D-Aspartate Receptor Encephalitis
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.
Official registry: https://clinicaltrials.gov/study/NCT06867991 · The First People's Hospital of Changzhou · enrollment listed as 200
What this phase means
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Ofatumumab combined with daratumumab, Ofatumumab, or Repeated intravenous immunoglobulin/plasma exchange therapy. The registry lists allocation as randomized. Autoimmune encephalitis is an autoimmune disease of the central nervous system that targets neuronal autoantigens.
They plan to enroll about 200 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
Safety and Efficacy of Combined B Cell Depleting theRapy And Daratumumab In Autoimmune Encephalitis
Interventions: Ofatumumab combined with daratumumab, Ofatumumab, Repeated intravenous immunoglobulin/plasma exchange therapy
Primary outcome (registry wording): Time to mRS<=2, i.e. the proportion of patients with mRS scores of 0-2
Who it is for (from inclusion criteria)
- Ages 12 Years to any
- 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 treatment
- mRS ≥ 3 points and neuropsychiatric manifestations inadequate to symptomatic treatment
Who the registry excludes
- 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)
- Alanine aminotransferase (ALT) \> 2.5 × upper limit of normal (ULN)
Public study contact (from the registry)
Wei Xie
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
2 listed- The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (recruiting)
- The First People's Hospital of Changzhou — Changzhou, Jiangsu, China (recruiting)
FAQ about this NCT record
Is NCT06867991 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06867991?
Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06867991?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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