Phase 2b Study to Assess Efficacy and Safety of Batoclimab in Adult Participants with Active CIDP
Research type
Research Study
Full title
A Phase 2b, Multi-center, Randomized, Quadruple-blind, Placebo-controlled Study of Batoclimab Treatment in Adult Participants with Active Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
IRAS ID
1006842
Contact name
Sarah Labriola
Contact email
Sponsor organisation
Immunovant Sciences, GmbH
Eudract number
2022-002718-17
Clinicaltrials.gov Identifier
Research summary
Chronic inflammatory demyelinating polyneuropathy (CIDP), is understood to be an autoimmune disorder characterised by demyelination (damage to the protective covering (myelin sheath) that surrounds nerve fibers in the brain, the nerves leading to the eyes (optic nerves) and spinal cord) of peripheral nerves driven by pathologic, autoreactive immunoglobulin G (IgG) antibodies. Effective first-line therapies exist for treatment of patients with CIDP. However, these treatments are associated with significant potential risk of adverse events (AEs), generally impose a high burden on patient’s time and effort and may be subject to restricted availability.
The purpose of this study is to see if the investigational drug, Batoclimab, is safe and helps people with chronic inflammatory demyelinating polyneuropathy (CIDP). Batoclimab is also known as IMVT-1401 (and was previously referred to as RVT-1401).
Batoclimab offers the potential for a targeted treatment that can be administered weekly as a convenient subcutaneous (SC) injection under the skin that targets the immune system and provide continuous and effective control of signs and symptoms.
REC name
London - Hampstead Research Ethics Committee
REC reference
23/LO/0122
Date of REC Opinion
27 Sep 2023
REC opinion
Further Information Favourable Opinion