A Study to Test the Efficacy and Safety of Riliprubart Against the Usual Treatment of Intravenous Immunoglobulin (IVIg) in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
NCT06290141 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 160
Last updated 2026-05-18
Summary
The purpose of the study is to evaluate efficacy of riliprubart compared to IVIg in adult participants with CIDP who are receiving maintenance treatment with IVIg. The study duration will be for a maximum of 109 weeks including screening, treatment phases, and follow-up.
Conditions
Interventions
- DRUG
-
riliprubart
Pharmaceutical form: Solution Route of administration: IV solution
- DRUG
-
Pharmaceutical form: Solution Route of administration: IV solution
- DRUG
-
riliprubart
Pharmaceutical form: Solution Route of administration: SC solution
- DRUG
-
Pharmaceutical form: Solution Route of administration: SC solution
- DRUG
-
IVIg
Pharmaceutical form: Concentrate for solution for infusion (or any other formulation approved locally) Route of administration: IV solution
- DRUG
-
Pharmaceutical form: Placebo to match intravenous immunoglobulin IVIg for IV infusio Route of administration: IV solution
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-08-21
- Primary Completion
- 2027-07-09
- Completion
- 2029-01-12
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Belgium
- Brazil
- Canada
- China
- Czechia
- Denmark
- France
- Germany
- Hungary
- Israel
- Italy
- Japan
- Mexico
- Norway
- Portugal
- Spain
- Sweden
- Switzerland
- Taiwan
- Turkey (Türkiye)
- United Kingdom
Study Locations
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