WHO ICTRP trial
A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER BASKET…
NL-OMON51721 · Overview of Medical Research in the Netherlands (NL-OMON) · Not Recruiting
Key facts
| Trial ID | NL-OMON51721 |
|---|---|
| Public title | A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER BASKET STUDY TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB IN PATIENTS WITH ANTI*N METHYL D ASPARTIC ACID RECEPTOR (NMDAR) OR ANTI*LEUCINE RICH GLIOMA INACTIVATED 1 (LGI1) ENCEPHALITIS |
| Scientific title | A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER BASKET STUDY TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB IN PATIENTS WITH ANTI*N METHYL D ASPARTIC ACID RECEPTOR (NMDAR) OR ANTI*LEUCINE RICH GLIOMA INACTIVATED 1 (LGI1) ENCEPHALITIS… |
| Primary sponsor | Roche Nederland B.V. |
| Registry | Overview of Medical Research in the Netherlands (NL-OMON) |
| Recruitment status | Not Recruiting |
| Study type | Interventional |
| Phase | 3 |
| Countries | Argentina;Australia;Canada;China;Czechia;France;Italy;Japan;Korea (the Republic of);Mexico;Netherlands;Poland;Russian Federation ;United States of America |
| Conditions | BRAIN Inflammation and encephalitis;10003816;10011305;BRAIN Inflammation and encephalitis |
| Interventions | During Part 1, participants will be randomly assigned in a 1:1 ratio to receive placebo or 60 mg, 120 mg, or 180 mg depending of weight satralizumab in each of the NMDAR AIE and LGI1 AIE cohorts. In Part 2, participants will be asked to… |
| Registration date | Nov 25, 2022 |
| Target size | 6 |
| Secondary IDs | 2021-002395-39;NL80647.078.22 |
| Registry page | onderzoekmetmensen.nl |
At a glance
- No Results available
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: