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]

ARISE

This trial is Currently recruiting
Registration number NCT05327114
The main purpose of this study is to evaluate the safety and efficacy of nipocalimab compared to placebo in delaying relapse in adults with chronic inflammatory demyelinating polyneuropathy (CIDP) who initially respond to nipocalimab in Stage A.

Program & service

This trial is being run with the Brain service, and as part of the Neurology program.

Trial phase

Phase 2

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Dr Mahima Kapoor

Key inclusion data

Diagnosed with CIDP according to criteria of the EAN/PNS 2021, progressing or relapsing forms. CIDP diagnosis to be adjudicated by independent committee during screening period. Adjusted INCAT disability score between 2 and 9 (a score of 2 has to be exclusively from leg disability). Has sufficient venous access to allow drug administration by infusion and blood sampling as per the protocol.

More information

To find out more about this clinical trial, please review full details on the ANZCTR website.

View on ANZCTR

If you would like further details or have any questions about this clinical trial, we encourage you to get in touch with us and a member of our team will be happy to provide you with more information.