WHO ICTRP trial
Inebilizumab efficacy and safety in adults with myasthenia gravis
EUCTR2020-000949-14-FR · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2020-000949-14-FR |
|---|---|
| Public title | Inebilizumab efficacy and safety in adults with myasthenia gravis |
| Scientific title | A RANDOMIZED, DOUBLE-BLIND, MULTICENTER, PLACEBO-CONTROLLED PHASE 3 STUDY WITH OPEN-LABEL PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF INEBILIZUMAB IN ADULTS WITH MYASTHENIA GRAVIS - Myasthenia Gravis INebilizumab Trial (MINT) |
| Primary sponsor | Viela Bio, Inc. |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | Ukraine;United States;Belarus;Finland;Spain;Guatemala;Turkey;Russian Federation;Israel;Italy;India;France;Canada;Argentina;Poland;Brazil;Australia;Denmark;Germany;Japan;China |
| Conditions | Myasthenia Gravis which is either due to acetylcholine receptor antibodies (AChR) or muscle specific kinase antibodies (MuSK). MedDRA version: 21.1 Level: PT Classification code 10028417 Term: Myasthenia gravis System Organ Class: 10029205… |
| Interventions | Product Name: Inebilizumab Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: INEBILIZUMAB Current Sponsor code: VIB0551 Other descriptive name: CD19-directed humanised afucosylated monoclonal antibody… |
| Registration date | Aug 10, 2020 |
| Target size | 252 |
| Secondary IDs | VIB0551.P3.S1 |
| Registry page | clinicaltrialsregister.eu |
At a glance
- No Results available
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About WHO ICTRP trial registrations
The WHO ICTRP combines trial registrations from primary registries worldwide into a single searchable index. Contact and ethics-committee details are not shown here.
Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: