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New treatment option for Chronic Inflammatory Demyelinating Polyneuropathy
Official title Imeroprubart in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
ClinicalTrials.gov ID: NCT07032662
What this study is testing
What is Imeroprubart?
Imeroprubart is an investigational medicine, given as an once-weekly injection under the skin, 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
- This is a Phase 2b study to evaluate the efficacy and safety of Imeroprubart in adults with CIDP.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
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
- Have met clinical diagnostic criteria for typical CIDP or one of the following CIDP variants: multifocal CIDP or motor CIDP per the 2021 European...
- Have electrodiagnostic test results supporting the diagnosis of CIDP per the EAN/PNS guideline on diagnosis and treatment of CIDP.
- Are currently on, and have been receiving chronic, stable doses of systemic corticosteroids (i.e., daily or every other day oral or pulse regimen)...
You likely can't join if
- Have current or prior history of IgM paraproteinemia with or without anti-myelin-associated-glycoprotein antibodies.
- Have distal, sensory, or focal CIDP, or have a diagnosis of autoimmune nodopathy per the EAN/PNS guideline on diagnosis and treatment of CIDP.
- Have polyneuropathy of causes other than CIDP including but not limited to:
- Multifocal motor neuropathy
- Hereditary demyelinating neuropathy
- Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin change syndromes (i.e., POEMS)
See the full eligibility criteria
- Have met clinical diagnostic criteria for typical CIDP or one of the following CIDP variants: multifocal CIDP or motor CIDP per the 2021 European Academy of Neurology/Peripheral Nerve Society (EAN/PNS) Guideline on...
- Have electrodiagnostic test results supporting the diagnosis of CIDP per the EAN/PNS guideline on diagnosis and treatment of CIDP.
- Are currently on, and have been receiving chronic, stable doses of systemic corticosteroids (i.e., daily or every other day oral or pulse regimen), or immunoglobulin therapy (IVIg or SCIg) ± low dose oral...
- Have current or prior history of IgM paraproteinemia with or without anti-myelin-associated-glycoprotein antibodies.
- Have distal, sensory, or focal CIDP, or have a diagnosis of autoimmune nodopathy per the EAN/PNS guideline on diagnosis and treatment of CIDP.
- Have polyneuropathy of causes other than CIDP including but not limited to:
- Multifocal motor neuropathy
- Hereditary demyelinating neuropathy
- Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin change syndromes (i.e., POEMS)
- Lumbosacral radiculoplexus neuropathy
- Systemic illnesses including vitamin deficiency syndromes and paraneoplastic neuropathies
- Drug- or toxin-induced
- Have diabetes mellitus (DM) and meets any of the following criteria:
- Does not have both typical CIDP and strong evidence of demyelination on nerve conduction study.
- In the opinion of the Investigator, there is evidence of poorly controlled DM preceding the diagnosis of CIDP.
- In the opinion of the Investigator, there is evidence of poorly controlled DM at screening.
- Have a history of myelopathy or evidence of central demyelination. Additional exclusion criteria are defined in the protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- Carlsbad, California, United States
- Orange, California, United States
- Rancho Mirage, California, United States
- San Francisco, California, United States
- Parker, Colorado, United States
- New Haven, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Maitland, Florida, United States
- Miami, Florida, United States
- Ormond Beach, Florida, United States
- Port Charlotte, Florida, United States
- Rockledge, Florida, United States
- Chicago, Illinois, United States
- Kansas City, Kansas, United States
- Nicholasville, Kentucky, United States
- Boston, Massachusetts, United States
- Worcester, Massachusetts, United States
- Detroit, Michigan, United States
- Las Vegas, Nevada, United States
+ 104 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 Tucson, Arizona, United States; Carlsbad, California, United States; Orange, California, United States; Rancho Mirage, California, United States; San Francisco, California, United States; Parker, Colorado, United States and 118 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.