Phase 3 Study to Assess Efficacy & Safety of Batoclimab in adult participants with gMG
Research type
Research Study
Full title
A Phase 3, Multi-center, Randomized, Quadruple-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants with Generalized Myasthenia Gravis (gMG)
IRAS ID
1005945
Contact name
Sarah Scott
Contact email
Sponsor organisation
Immunovant Sciences GmbH
Eudract number
2021-000249-42
Clinicaltrials.gov Identifier
Research summary
The purpose of the current research study is to learn how well batoclimab (investigational medicine) works and how safe it is, when compared with placebo (an inactive material that looks like batoclimab but does not have any active medicine) in participants with Generalized Myasthenia Gravis (gMG).
Batoclimab is injected subcutaneously (under the skin) once per week. It is designed to block the binding of a specific receptor to molecules (called “antibodies”) in the immune system. Antibodies help the body fight off infections. However, in gMG, immune system makes antibodies that attack the muscles and nerves of the arms, legs, and chest and thereby limiting movement and even interfering with breathing. By blocking the binding of the receptor to these antibodies, batoclimab is thought to potentially improve gMG symptoms.
Participants will be in the study for up to approximately 84 weeks (1 ½ years) and this study includes 4 periods: a screening period of up to 4 weeks, two 12-week treatment periods (referred to as Period 1 and Period 2), a 52-week long-term extension period (referred to as Period 3), and a 4 week follow up period.
The study population will consist of participants 18 years or older who have mild to severe gMG and it will take place in approximately 95 investigational centres across North America, Asia, Europe, Australia, Central America, and South America with about 210 people with gMG participating.REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
22/YH/0275
Date of REC Opinion
20 Jul 2023
REC opinion
Further Information Favourable Opinion