drugset / Trial / NCT03194815

IVIG and Rituximab in Antibody-associated Psychosis - SINAPPS2

NCT03194815

Phase 2 Active not recruiting 70 enrolled University of Cambridge University of Oxford · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

A randomised phase II double-blinded placebo-controlled trial designed to explore the utility of immunotherapy for patients with acute psychosis associated with anti-neuronal membranes (NMDA-receptor or Voltage Gated Potassium Channel). Primary objective: To test the efficacy of immunotherapy (IVIG and rituximab) for patients with acute psychosis associated with anti-neuronal membranes. Secondary objective: To test safety of immunotherapy (IVIG and rituximab) for patients with acute psychosis associated with anti-neuronal membranes.

Timeline

Start
2017-11-01
Primary completion
2027-04-30
Completion
2027-04-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Immune Globulin Intravenous (Human) Protein / enzyme biologic 2 g/kg Intravenous
Comparator Rituximab Monoclonal antibody 1 g