clinical trial · NCT06858579
A Study to Evaluate the Efficacy and Safety of DNTH103 in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CAPTIVATE)
Chronic Inflammatory Demyelinating PolyneuropathyClaseprubartClaseprubartPlacebo
brief summary
The purpose of this Phase 3 study is to demonstrate the efficacy of claseprubart (DNTH103) as compared to placebo in participants with chronic inflammatory demyelinating polyneuropathy (CIDP).
started
Feb 10, 2025
primary completion
Dec 31, 2028
completion
Dec 31, 2030
last updated
Jun 2, 2026
detailed description
The study includes the following periods:
* Part A: An open-label period (up to 13 weeks) * Part B: A randomized, placebo-controlled, double-blind treatment period (up to 52 weeks) for participants who respond to DNTH103 in Part A * Optional open-label extension (OLE) for eligible participants (up to 104 weeks) * Safety follow-up (40 weeks)
official title
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)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol