Clinical Trials in Austria / NCT07032662
Recruiting
Phase 2
Imeroprubart in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
NCT07032662 · tracked via the Priya Life Science Austria tracker
Condition(s) studied
Chronic Inflammatory Demyelinating Polyneuropathy
Investigational drug(s) / intervention(s)
ImeroprubartPlacebo
Imeroprubart: Dose 1 subcutaneous (SC) once weekly (QW) for 24 weeks (Period 1) and 52 weeks (Period 2)
Placebo: Matching placebo SC QW for 24 weeks (Period 1)
Study summary
This is a Phase 2b study to evaluate the efficacy and safety of Imeroprubart in adults with CIDP.
Eligibility
Inclusion Criteria:
* Have met clinical diagnostic criteria for typical CIDP (including incomplete 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 Diagnosis and Treatment of CIDP.
* 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) ± corticosteroid therapy (either low dose oral corticosteroids or pulse corticosteroids) for at least 3 months for the treatment of CIDP at the time of the Screening Visit.
Additional inclusion criteria are defined in the protocol.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
- Proportion of participants remaining Relapse-free by Week 24 — Baseline, Week 24
Relapse is defined as a worsening (increase) of ≥ 1 point on the adjusted inflammatory neuropathy cause and treatment (aINCAT) score at any time point relative to Period 1 Baseline.
Trial sites (142)
| Facility | City | Region | Status |
|---|---|---|---|
| Site Number - 1612 | Tucson | Arizona | Recruiting |
| Site Number - 1618 | Carlsbad | California | Recruiting |
| Site Number - 1637 | Mission Hills | California | Recruiting |
| Site Number - 1619 | Orange | California | Recruiting |
| Site Number - 1607 | Rancho Mirage | California | Recruiting |
| Site Number -1608 | San Francisco | California | Recruiting |
| Site Number - 1626 | Parker | Colorado | Recruiting |
| Site Number - 1621 | New Haven | Connecticut | Recruiting |
| Site Number - 1630 | Washington D.C. | District of Columbia | Recruiting |
| Site Number - 1601 | Washington D.C. | District of Columbia | Recruiting |
| Site Number - 1603 | Maitland | Florida | Recruiting |
| Site Number - 1606 | Miami | Florida | Recruiting |
| Site Number - 1617 | Ormond Beach | Florida | Recruiting |
| Site Number - 1620 | Port Charlotte | Florida | Recruiting |
| Site Number - 1633 | Rockledge | Florida | Recruiting |
| Site Number - 1632 | Chicago | Illinois | Recruiting |
| Site Number - 1602 | Kansas City | Kansas | Recruiting |
| Site Number - 1611 | Nicholasville | Kentucky | Recruiting |
| Site Number - 1623 | Boston | Massachusetts | Recruiting |
| Site Number - 1625 | Worcester | Massachusetts | Recruiting |
| Site Number - 1629 | Detroit | Michigan | Recruiting |
| Site Number - 1634 | Las Vegas | Nevada | Recruiting |
| Site Number - 1605 | New York | New York | Recruiting |
| Site Number - 1627 | New York | New York | Recruiting |
| Site Number - 1635 | Chapel Hill | North Carolina | Not Yet Recruiting |
| Site Number - 1610 | Charlotte | North Carolina | Recruiting |
| Site Number - 1624 | Canton | Ohio | Not Yet Recruiting |
| Site Number - 1631 | Yukon | Oklahoma | Recruiting |
| Site Number - 1614 | Portland | Oregon | Recruiting |
| Site Number - 1616 | Philadelphia | Pennsylvania | Recruiting |
| Site Number - 1622 | Houston | Texas | Recruiting |
| Site Number - 1628 | San Antonio | Texas | Recruiting |
| Site Number - 1613 | Milwaukee | Wisconsin | Recruiting |
| Site Number - 5005 | Rosario | Santa Fe Province | Recruiting |
| Site Number - 5002 | Buenos Aires | Argentina | Not Yet Recruiting |
| Site Number - 5006 | Buenos Aires | Argentina | Recruiting |
| Site Number - 5001 | Córdoba | Argentina | Recruiting |
| Site Number - 5003 | Córdoba | Argentina | Recruiting |
| Site Number - 5000 | Rosario | Argentina | Recruiting |
| Site Number - 5100 | Macquarie Park | Australia | Recruiting |
+ 102 more sites — see the full list on the official registry below.
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07032662 on ClinicalTrials.gov ↗ ← All trials in Austria