Efficacy and Safety Study of Nipocalimab for Adults with CIDP
Research type
Research Study
Full title
Phase 2/3, Multistage, Multicenter, Randomized, Double-Blind, Placebo-Controlled Parallel Group Withdrawal Study to Evaluate the Efficacy and Safety of Nipocalimab Administered to Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
IRAS ID
1004630
Contact name
Ansu Lebbie
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2021-003234-37
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to see if a medication called nipocalimab is safe and useful for treating adults with a disease called Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). CIDP is a rare disease, where the body’s natural defences, for example antibodies, attack the covering of the nerves, called “myelin”, and damage nerve function.
About 300 participants will take part in this study worldwide and they could be in the study for up to approximately 5 years, with the possibility of going onto a long-term extension period. The study medication will be delivered via intravenous (IV) infusion (through a vein). The infusion will be done at the study clinic by either the study doctor or study staff.
The study will consist of a screening period, run in period, open label treatment, double blind treatment, open label extension and a follow up period.
During the Open Label Treatment, the participants will receive 30 mg/kg of nipocalimab for the first infusion on Day 1 and 15 mg/kg of nipocalimab from Week 2, every 2 weeks. It will be important that the participants do not miss or skip infusions.
During the Double Blind Treatment Period 4 the participants will either receive nipocalimab or placebo. They will randomly be assigned into either, the group with placebo infusion every 2 weeks or the group with nipocalimab infusion of 15 mg/kg every 2 weeks
During the Double Blind Treatment neither the participant nor the study staff will know which treatment group the person taking part is in.
During the Open Label Extension Period 5, the participant will receive dose of 15 mg/kg of nipocalimab every 2 weeks.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
22/EM/0110
Date of REC Opinion
4 Jul 2022
REC opinion
Further Information Favourable Opinion