A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP
Purpose
The main purpose of this study is to compare empasiprubart and IVIg for treating people with CIDP. This study consists of a Part A where participants will either receive empasiprubart and a placebo resembling IVIg, or IVIg and a placebo resembling empasiprubart for 24 weeks (6 months). Following Part A, participants will enter Part B in which all participants will receive empasiprubart for 96 weeks (24 months).
Conditions
- Chronic Inflammatory Demyelinating Polyneuropathy
- CIDP
- CIDP - Chronic Inflammatory Demyelinating Polyneuropathy
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Meets criteria for CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021) - Has either typical CIDP or 1 of the following CIDP variants: motor CIDP, multifocal CIDP (also known as Lewis-Sumner syndrome), focal CIDP, or distal CIDP - Has responded to IVIg in the past 5 years - Receiving treatment with IVIg within a standard optimal maintenance dosing regimen, with a minimum weekly IVIg dose of at least 0.125 g/kg - Has residual disability and active disease
Exclusion Criteria
- Besides the indication under study, known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of CIDP or puts the participant at undue risk, including polyneuropathy of other causes - Meets the criteria for possible or sensory CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021) - Use of other long-acting immunomodulatory treatment
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Part A - empasiprubart + IVIg-placebo |
During Part A, participants receive empasiprubart and a placebo resembling the IVIg treatment in this arm. |
|
|
Active Comparator Part A - IVIg + empasiprubart-placebo |
During Part A, participants receive IVIg and a placebo resembling the empasiprubart treatment in this arm. |
|
|
Experimental Part B - empasiprubart |
After completion of part A, participants can proceed to part B where they receive empasiprubart (no IVIg). Participants from the empasiprubart + IVIg- placebo arm in Part A will receive empasiprubart placebo once to maintain the blind of Part A. |
|
Recruiting Locations
MedStar Washington Hospital Center
Washington D.C. 4140963, District of Columbia 4138106 20010
Washington D.C. 4140963, District of Columbia 4138106 20010
Homestead Associates in Research Inc
Homestead 4159050, Florida 4155751 33033
Homestead 4159050, Florida 4155751 33033
Visionary Investigators Network
Miami 4164138, Florida 4155751 33133
Miami 4164138, Florida 4155751 33133
Erlanger Health System
Columbia 4352053, Maryland 4361885 21044
Columbia 4352053, Maryland 4361885 21044
NeuroCarePlus
Houston 4699066, Texas 4736286 77094
Houston 4699066, Texas 4736286 77094
National Neuromuscular Research Institute
Irving 4700168, Texas 4736286 75063
Irving 4700168, Texas 4736286 75063
More Details
- NCT ID
- NCT06920004
- Status
- Recruiting
- Sponsor
- argenx