NCT06858579

A Study to Evaluate the Efficacy and Safety of DNTH103 in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CAPTIVATE)

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 480 (estimated)
• Sponsor: Dianthus Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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).

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)

Conditions

• Chronic Inflammatory Demyelinating Polyneuropathy

Interventions

Type	Name	Description
DRUG	DNTH103	IV Infusion
DRUG	DNTH103	SC injection
DRUG	Placebo	SC injection

Timeline

• Start date: 2025-02-10
• Primary completion: 2028-12-31
• Completion: 2030-12-31
• First posted: 2025-03-05
• Last updated: 2026-03-27

Locations

158 sites across 27 countries: United States, Argentina, Australia, Belgium, Brazil, Bulgaria, China, Colombia, Croatia, Denmark, France, Georgia, Germany, Israel, Italy, Latvia, Malaysia, Netherlands, North Macedonia, Philippines, Poland, Romania, Serbia, South Korea, Spain, Thailand, United Kingdom

Regulatory

• FDA-regulated drug study