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)
Dianthus Therapeutics
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).
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)
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Must have given written informed consent before any study-related activities are carried out. 2. Weight range between 40 kilograms (kg) and 120 kg. 3. Confirmed diagnosis of CIDP or possible CIDP. Participants must have either typical CIDP or one of the following variants: motor or multifocal CIDP. Diagnosis must be confirmed by the Independent CIDP Review Panel. 4. CIDP Disease Activity Status (CDAS) score ≥ 3 at screening. 5. Must be neurologically stable. 6. Must have an INCAT score between 2 and 9 inclusive. 7. Must fulfill one of the following treatment conditions…
Interventions
- DrugClaseprubart
IV Infusion
- DrugClaseprubart
SC injection
- DrugPlacebo
SC injection
Locations (158)
- Clinical Study SiteBirmingham, Alabama
- Clinical Study SitePhoenix, Arizona
- Clinical Study SiteScottsdale, Arizona
- Clinical Study SiteLos Angeles, California
- Clinical Study SiteSan Francisco, California
- Clinical Study SiteSan Francisco, California