Imeroprubart in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Imeroprubart, Placebo.
- Who it may be relevant to
- Registry conditions: Chronic Inflammatory Demyelinating Polyneuropathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Australia, Austria, Belgium +25
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 2b, Multi-center, Randomized, Double-blind, Placebo-controlled Study of IMVT-1402 Treatment in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Overview
This is a Phase 2b study to evaluate the efficacy and safety of Imeroprubart in adults with CIDP.
Detailed description
This is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Imeroprubart in adult participants with active CIDP.
Interventions
- Drug Imeroprubart
Dose 1 subcutaneous (SC) once weekly (QW) for 24 weeks (Period 1) and 52 weeks (Period 2) - Drug Placebo
Matching placebo SC QW for 24 weeks (Period 1)
Primary outcome measures
- Proportion of participants remaining Relapse-free by Week 24 [Time frame: Baseline, Week 24]
Secondary outcome measures (4)
- Change from baseline to Week 24 in Inflammatory Rasch-Built Overall Disability Scale (I-RODS) [Time frame: Baseline and Up to Week 24]
- Change from baseline to Week 24 in Mean Grip Strength in the dominant hand [Time frame: Baseline and Up to Week 24]
- Change from baseline to Week 24 in Medical Research Council Sum Score (MRC-SS) [Time frame: Baseline and Up to Week 24]
- Change from baseline to Week 24 in aINCAT score [Time frame: Baseline and Up to Week 24]
Eligibility criteria
Inclusion 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 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) ± low dose oral 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 33 centers
- Site Number - 1612 — Tucson
- Site Number - 1618 — Carlsbad
- Site Number - 1637 — Mission Hills
- Site Number - 1619 — Orange
- Site Number - 1607 — Rancho Mirage
- Site Number -1608 — San Francisco
- Site Number - 1626 — Parker
- Site Number - 1621 — New Haven
- … and 25 more centers
Italy · 11 centers
Center list to be confirmed — check the primary protocol.
Poland · 10 centers
Center list to be confirmed — check the primary protocol.
Brazil · 8 centers
- Site Number - 5507 — Belo Horizonte
- Site Number - 5506 — Brasília
- Site Number - 5503 — Campinas
- Site Number - 5500 — Curitiba
- Site Number - 5502 — Joinville
- Site Number - 5501 — Porto Alegre
- Site Number - 5504 — Porto Alegre
- Site Number - 5505 — Vila Clementino
Greece · 7 centers
- Site Number - 3901 — Alexandroupoli
- Site Number - 3902 — Athens
- Site Number - 3905 — Chaïdári
- Site Number - 3906 — Heraklion
- Site Number - 3903 — Ioannina
- Site Number - 3904 — Larissa
- Site Number - 3900 — Pátrai
Germany · 6 centers
- Site Number - 6505 — Berlin
- Site Number - 6501 — Bochum
- Site Number - 6504 — Essen
- Site Number - 6500 — Tübingen
- Site Number - 6503 — Ulm
- Site Number - 6502 — Würzburg
Spain · 6 centers
Center list to be confirmed — check the primary protocol.
Turkey (Türkiye) · 6 centers
Center list to be confirmed — check the primary protocol.
Argentina · 5 centers
- Site Number - 5005 — Rosario
- Site Number - 5002 — Buenos Aires
- Site Number - 5001 — Córdoba
- Site Number - 5003 — Córdoba
- Site Number - 5000 — Rosario
Bulgaria · 5 centers
- Site Number - 5601 — Pleven
- Site Number - 5600 — Sofia
- Site Number - 5602 — Sofia
- Site Number - 5603 — Sofia
- Site Number - 5604 — Sofia
Bosnia and Herzegovina · 4 centers
- Site Number - 5400 — Banja Luka
- Site Number - 5402 — Bihać
- Site Number - 5401 — Mostar
- Site Number - 5403 — Sarajevo
Mexico · 4 centers
Center list to be confirmed — check the primary protocol.
Serbia · 4 centers
Center list to be confirmed — check the primary protocol.
United Kingdom · 4 centers
Center list to be confirmed — check the primary protocol.
Australia · 3 centers
- Site Number - 5100 — Macquarie Park
- Site Number - 5103 — Parkville
- Site Number - 5102 — Woolloongabba
Hungary · 3 centers
- Site Number - 7551 — Budapest
- Site Number - 7550 — Kistarcsa
- … and 1 more center
Peru · 3 centers
Center list to be confirmed — check the primary protocol.
Portugal · 3 centers
Center list to be confirmed — check the primary protocol.
Slovakia · 3 centers
Center list to be confirmed — check the primary protocol.
Denmark · 2 centers
- Site Number - 3600 — Copenhagen
- Site Number - 3601 — Odense
Romania · 2 centers
Center list to be confirmed — check the primary protocol.
Austria · 1 center
- Site Number - 5200 — Vienna
Belgium · 1 center
- Site Number - 5300 — Leuven
Colombia · 1 center
- Site Number - 5800 — Bogotá
Estonia · 1 center
- Site Number - 7251 — Tallinn
Finland · 1 center
- Site Number - 3800 — Turku
Ireland · 1 center
Center list to be confirmed — check the primary protocol.
Netherlands · 1 center
Center list to be confirmed — check the primary protocol.
Norway · 1 center
Center list to be confirmed — check the primary protocol.
Slovenia · 1 center
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07032662 · IMVT-1402-2401