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Tests treatment safety and results for Chronic Inflammatory Demyelinating Polyneuropathy
Official title A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP
ClinicalTrials.gov ID: NCT07091630
What this study is testing
What is Empasiprubart IV?
Empasiprubart IV is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for chronic inflammatory demyelinating polyneuropathy.
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
- The main purpose of this study is to demonstrate the efficacy and safety of empasiprubart in adults with CIDP. The study consists of a part A where participants will either receive empasiprubart or placebo for 24 weeks (6 months).
- 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 (including motor-predominant CIDP), multifocal CIDP (also known as...
- Has residual disability and active disease
- Has not received previous treatment for CIDP; or has stopped receiving CIDP treatment; or is receiving CIDP treatment (pulsed or oral...
- Participants already receiving CIDP treatment will have to discontinue their CIDP treatment before first IMP administration and must be willing to...
You likely can't join if
- Meets the criteria for possible CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021)
- Sensory CIDP (including sensory-predominant CIDP)
- Polyneuropathy of other causes
- Clinical diagnosis of systemic lupus erythematosus (SLE)
- Use of other long-acting immunomodulatory treatment or prior treatment (at any time) with total lymphoid irradiation or bone marrow transplantation
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Rancho Mirage, California, United States
- Colorado Springs, Colorado, United States
- Washington D.C., District of Columbia, United States
- Miami, Florida, United States
- Naples, Florida, United States
- Slidell, Louisiana, United States
- Philadelphia, Pennsylvania, United States
- Austin, Texas, United States
- Houston, Texas, United States
- Rosario, Argentina
- Linz, Upper Austria, Austria
- Vienna, Austria
- Sofia, Sofia, Bulgaria
- Pleven, Bulgaria
- Sofia, Bulgaria
- Fuzhou, Fujian, China
- Beijing, China
- Guangzhou, China
- Xi'an, China
+ 31 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 - 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?
Study sites include Birmingham, Alabama, United States; Rancho Mirage, California, United States; Colorado Springs, Colorado, United States; Washington D.C., District of Columbia, United States; Miami, Florida, United States; Naples, Florida, United States and 45 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.