Chronic Inflammatory Demyelinating Polyneuropathy study: Empasiprubart vs IVIg
Official title A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP
ClinicalTrials.gov ID: NCT06920004
What this study is testing
What is empasiprubart?
an investigational intravenous biological being studied as a potential treatment for chronic inflammatory demyelinating polyneuropathy (CIDP)
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether empasiprubart works as well as IVIg for treating CIDP.
- Who it's for
- You may be able to join if you are an adult with chronic inflammatory demyelinating polyneuropathy.
- What's involved
- You will be randomly given either empasiprubart with a pretend IVIg or IVIg with a pretend empasiprubart for 24 weeks. After that, everyone will receive empasiprubart for another 96 weeks.
- Time commitment
- The study lasts about 120 weeks with regular check‑ins during the first 24 weeks and then during the 96‑week follow‑up.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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
You likely can't join if
- Besides the indication under study, known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical...
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Tucson, Arizona, United States
- Rancho Mirage, California, United States
- Colorado Springs, Colorado, United States
- Washington D.C., District of Columbia, United States
- Homestead, Florida, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Nicholasville, Kentucky, United States
- Slidell, Louisiana, United States
- Columbia, Maryland, United States
- Ann Arbor, Michigan, United States
- Cincinnati, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Knoxville, Tennessee, United States
- Houston, Texas, United States
- Irving, Texas, United States
- Córdoba, Argentina
- Rosario, Argentina
- Liverpool, New South Wales, Australia
+ 77 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Tucson, Arizona, United States; Rancho Mirage, California, United States; Colorado Springs, Colorado, United States; Washington D.C., District of Columbia, United States; Homestead, Florida, United States and 91 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.