A Phase 2, Open-label Study to Evaluate the Safety, Tolerability, and Efficacy of Intravenous NVG-2089 in Participants with Chronic Inflammatory Demyelinating Polyneuropathy [CIDP]

The purpose of the study is to evaluate the safety of NVG-2089 and to evaluate how well patients respond to this investigational treatment. NVG-2089 is a new drug that is being developed for treating patients with CIDP. NVG-2089 is designed to mimic the effects of a protein called IVIg. NVG-2089 is designed to potentially help the immune system by attaching (binding) to certain receptors in the body and activating them, which helps reduce inflammation and supports how the immune system works.

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 or Possible CIDP according to criteria of the EAN/PNS 2021. Must have an adjusted INCAT score as follows: a. Treatment-naïve participants: ?2 at screening b. Treatment-experienced participants: 2-7 at screening. Treatment-experienced participants: On stable dose of IVIg or SCIg with no disease exacerbations for 8 weeks prior to screening. Participants must be willing to discontinue IVIg or SCIg at least 3 weeks (±1 week) prior to dosing with the study drug. Participants on IVIg must be on maintenance dose of 0.4 to 1 g/kg every 2 to 6 weeks per EAN/PNS recommendation. Participants on SCIg should not exceed the dose of 0.4 g/kg per week.