Clinical Trials
Empasiprubart
Study Status
Start up
ARGX-117-2402
Clinicaltrials.Gov Number
NCT07091630
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) is a rare, long-lasting autoimmune disease that can worsen over time. CIDP occurs when the immune system mistakenly attacks the covering of some nerve cells in the arms and legs. CIDP can lead to difficulty walking or performing typical daily tasks without help.
The Emnergize study is designed to evaluate how the investigational study drug* may work (also known as efficacy) and how safe it is for the use in adults living with CIDP. This study will evaluate the clinical study drug compared to a placebo.
*The investigational study drug, empasiprubart, is not approved by any regulatory agency for the use in CIDP as efficacy and safety have not been established.
You may be eligible to participate if you are:
Additional criteria to participate apply which the study doctor will discuss with you.
Screening -
Up to 2 months
Treatment –
Part A 6 months, Part B up to 24 months
Follow up –
Up to 15 Months
The study consists of 3 phases:
Screening phase
Up to 2 months before starting the study treatment. The study team will assess if you meet the eligibility criteria.
Treatment phase
The study will be conducted in two parts, Part A and Part B, with a maximum of 30 months of investigational study drug administration.
PART A:
In Part A, enrolled participants will be assigned to 1 of the 2 treatment groups to receive either investigational study drug or placebo. Participants have a 67% chance to receive the investigational study drug.
Participants will either receive the investigational study drug or the placebo given through an infusion into a vein in your arm (intravenously).
PART B:
All participants entering part B will receive the investigational study drug for up to 24 months to evaluate safety and efficacy. Participants will not receive placebo during part B.
Follow up phase:
For up to 15 months, after participants complete Part B, the study team will continue to monitor for safety.
The clinical study sites are located across the world. Discover open study sites on the map.