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

NCT06858579 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2026-05-13

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Claseprubart

IV Infusion

DRUG

Claseprubart

SC injection

DRUG

Placebo

SC injection

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-10
Primary Completion
2028-12-31
Completion
2030-12-31
FDA Drug
Yes

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

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06858579 on ClinicalTrials.gov