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
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
-
SC injection
Sponsors & Collaborators
- lead INDUSTRY
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
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