A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of DNTH103 in Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CAPTIVATE) (NCT06858579)

The purpose of this Phase 3 study is to demonstrate the efficacy of DNTH103 as compared to placebo in participants with chronic inflammatory demyelinating polyneuropathy (CIDP).

Trial phase

Phase 3

Trial participation type

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

Principal investigator

Dr Mahima Kapoor

Key inclusion data

A diagnosis of CIDP or possible CIDP per the 2021 EAN/PNS guidelines. Participants must have either typical CIDP or one of the following variants: motor or multifocal CIDP. Diagnosis must be confirmed by the ICRP, which may determine that a participant requires additional standard-of-care procedures (eg, nerve conduction studies and imaging studies) to inform their assessment. CIDP Disease Activity Status (CDAS) score ? 3 at Screening. Must be neurologically stable (ie, no relapses or other neurological events that could affect examinations) at Screening and confirmed prior to dosing on Day 1 of Part A. The participant must be stabilized at least 1 week prior to Day 1 of Part A. Clinically meaningful deterioration may occur during Screening (eg, during corticosteroid tapering) and is defined as at least one of the following: a. ? 1-point increase in adjusted INCAT score; b. ? 4 points decrease in I-RODS total score; c. ? 3 points decrease in MRC-SS; d. ? 8 kilopascal worsening in mean grip strength (one hand) or; e. a significant deterioration in the participant's health per the Investigator's judgment.