A PHASE-2B, DOUBLE-BLIND, RANDOMIZED CONTROLLED TRIAL TO EVALUATE THE ACTIVITY AND SAFETY OF INEBILIZUMAB IN ANTI-NMDA RECEPTOR ENCEPHALITIS AND ASSESS MARKERS OF DISEASE (EXTINGUISH)

Conditions

anti-N-methyl-D-aspartate receptor encephalitis (anti-NMDAR encephalitis)

Brief summary

Change in mRS at 16 weeks, Inebilizumab safety, as measured by the number of treatment-emergent adverse events and treatment-emergent serious adverse events from randomization to 24 weeks

Detailed description

Time to mRS ≤ 2, corrected for baseline value, over 16 weeks, CASE Score (linear mixed model), corrected from baseline value to Week 24 (Weeks 6 and 16), mRS at Week 6 as measured by proportional odds logistic regression/shift analysis, Proportion of participants who meet the protocol-defined criteria for needing rescue therapy with cyclophosphamide at Week 6, as measured by logistic regression, Cognitive outcome at Week 24 as measured by the total scaled score on the RBANS + total raw score on the TMT, Clinician global impression of change (CGI-I) and Caregiver global impression of change (CaGI) over 24 weeks, as measured by ordinal repeated measures models, Survival as measured by a Kaplan-Meier analysis

Related papers

No related papers found yet.

Papers published before 2008-02-04 may not appear yet. Historical indexing is in progress.

Interventions

DRUGPlangamma 50 mg/ml solución para perfusión

DRUGMETHYLPREDNISOLONE

DRUGCETIRIZINE

DRUGFlebogamma DIF 50 mg/ml solution for infusion

DRUGCYCLOPHOSPHAMIDE

DRUGPrivigen 100 mg/ml solution for infusion

DRUGPlacebo is saline bag without added substances

DRUGlabelled and provided by the unblinded hospital site pharmacist

DRUGUplizna 100 mg concentrate for solution for infusion

DRUGKIOVIG 100 mg/ml solution for infusion

DRUGPARACETAMOL

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change in mRS at 16 weeks, Inebilizumab safety, as measured by the number of treatment-emergent adverse events and treatment-emergent serious adverse events from randomization to 24 weeks	—

Secondary

Measure	Time frame
Time to mRS ≤ 2, corrected for baseline value, over 16 weeks, CASE Score (linear mixed model), corrected from baseline value to Week 24 (Weeks 6 and 16), mRS at Week 6 as measured by proportional odds logistic regression/shift analysis, Proportion of participants who meet the protocol-defined criteria for needing rescue therapy with cyclophosphamide at Week 6, as measured by logistic regression, Cognitive outcome at Week 24 as measured by the total scaled score on the RBANS + total raw score on the TMT, Clinician global impression of change (CGI-I) and Caregiver global impression of change (CaGI) over 24 weeks, as measured by ordinal repeated measures models, Survival as measured by a Kaplan-Meier analysis	—

Measure

Time frame

Time to mRS ≤ 2, corrected for baseline value, over 16 weeks, CASE Score (linear mixed model), corrected from baseline value to Week 24 (Weeks 6 and 16), mRS at Week 6 as measured by proportional odds logistic regression/shift analysis, Proportion of participants who meet the protocol-defined criteria for needing rescue therapy with cyclophosphamide at Week 6, as measured by logistic regression, Cognitive outcome at Week 24 as measured by the total scaled score on the RBANS + total raw score on the TMT, Clinician global impression of change (CGI-I) and Caregiver global impression of change (CaGI) over 24 weeks, as measured by ordinal repeated measures models, Survival as measured by a Kaplan-Meier analysis

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Countries

Netherlands, Spain

Outcome results

None listed