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This is a Phase 2b study to evaluate the efficacy and safety of Imeroprubart in adults with CIDP.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imeroprubart | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imeroprubart | Drug | Dose 1 subcutaneous (SC) once weekly (QW) for 24 weeks (Period 1) and 52 weeks (Period 2) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants remaining Relapse-free by 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. | Baseline, Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to Week 24 in Inflammatory Rasch-Built Overall Disability Scale (I-RODS) | Baseline and Up to Week 24 | |
| Change from baseline to Week 24 in Mean Grip Strength in the dominant hand | Baseline and Up to Week 24 |
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Inclusion Criteria:
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:
Have diabetes mellitus (DM) and meets any of the following criteria:
Have a history of myelopathy or evidence of central demyelination. Additional exclusion criteria are defined in the protocol.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Contact | Contact | 18007970414 | clinicaltrials@immunovant.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Number - 1612 | Recruiting | Tucson | Arizona | 85718 | United States | |
| Site Number - 1618 |
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Sponsor, care provider and outcome assessor will also be blinded.
| Placebo | Drug | Matching placebo SC QW for 24 weeks (Period 1) |
|
| Change from baseline to Week 24 in Medical Research Council Sum Score (MRC-SS) | Baseline and Up to Week 24 |
| Change from baseline to Week 24 in aINCAT score | Baseline and Up to Week 24 |
| Recruiting |
| Carlsbad |
| California |
| 92011 |
| United States |
| Site Number - 1619 | Recruiting | Orange | California | 92868 | United States |
| Site Number - 1607 | Recruiting | Rancho Mirage | California | 92270 | United States |
| Site Number -1608 | Recruiting | San Francisco | California | 94109 | United States |
| Site Number - 1626 | Recruiting | Parker | Colorado | 80138 | United States |
| Site Number - 1621 | Recruiting | New Haven | Connecticut | 06511 | United States |
| Site Number - 1630 | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
| Site Number - 1601 | Recruiting | Washington D.C. | District of Columbia | 20037 | United States |
| Site Number - 1603 | Recruiting | Maitland | Florida | 32751 | United States |
| Site Number - 1606 | Recruiting | Miami | Florida | 33136 | United States |
| Site Number - 1617 | Recruiting | Ormond Beach | Florida | 32174 | United States |
| Site Number - 1620 | Recruiting | Port Charlotte | Florida | 33952 | United States |
| Site Number - 1633 | Recruiting | Rockledge | Florida | 32955 | United States |
| Site Number - 1632 | Recruiting | Chicago | Illinois | 60637-1443 | United States |
| Site Number - 1602 | Recruiting | Kansas City | Kansas | 66205 | United States |
| Site Number - 1611 | Recruiting | Nicholasville | Kentucky | 40356 | United States |
| Site Number - 1623 | Recruiting | Boston | Massachusetts | 02114 | United States |
| Site Number - 1625 | Recruiting | Worcester | Massachusetts | 01655 | United States |
| Site Number - 1629 | Recruiting | Detroit | Michigan | 48201 | United States |
| Site Number - 1634 | Recruiting | Las Vegas | Nevada | 89106 | United States |
| Site Number - 1605 | Recruiting | New York | New York | 10032 | United States |
| Site Number - 1627 | Recruiting | New York | New York | 10065 | United States |
| Site Number - 1635 | Not yet recruiting | Chapel Hill | North Carolina | 27514 | United States |
| Site Number - 1610 | Not yet recruiting | Charlotte | North Carolina | 28204 | United States |
| Site Number - 1624 | Not yet recruiting | Canton | Ohio | 44718 | United States |
| Site Number - 1631 | Recruiting | Yukon | Oklahoma | 73099 | United States |
| Site Number - 1614 | Not yet recruiting | Portland | Oregon | 97239 | United States |
| Site Number - 1616 | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
| Site Number - 1622 | Recruiting | Houston | Texas | 77030 | United States |
| Site Number - 1628 | Recruiting | San Antonio | Texas | 78229 | United States |
| Site Number - 1613 | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
| Site Number - 5005 | Recruiting | Rosario | Santa Fe Province | Argentina |
| Site Number - 5002 | Not yet recruiting | Buenos Aires | Argentina |
| Site Number - 5001 | Recruiting | Córdoba | Argentina |
| Site Number - 5003 | Recruiting | Córdoba | Argentina |
| Site Number - 5000 | Recruiting | Rosario | Argentina |
| Site Number - 5100 | Recruiting | Macquarie Park | Australia |
| Site Number - 5103 | Recruiting | Parkville | Australia |
| Site Number - 5102 | Recruiting | Woolloongabba | Australia |
| Site Number - 5200 | Recruiting | Vienna | Austria |
| Site Number - 5300 | Recruiting | Leuven | Belgium |
| Site Number - 5400 | Recruiting | Banja Luka | Bosnia and Herzegovina |
| Site Number - 5402 | Not yet recruiting | Bihać | Bosnia and Herzegovina |
| Site Number - 5401 | Recruiting | Mostar | Bosnia and Herzegovina |
| Site Number - 5403 | Recruiting | Sarajevo | Bosnia and Herzegovina |
| Site Number - 5506 | Recruiting | Brasília | Brazil |
| Site Number - 5503 | Not yet recruiting | Campinas | Brazil |
| Site Number - 5500 | Recruiting | Curitiba | Brazil |
| Site Number - 5502 | Recruiting | Joinville | Brazil |
| Site Number - 5501 | Recruiting | Porto Alegre | Brazil |
| Site Number - 5504 | Recruiting | Porto Alegre | Brazil |
| Site Number - 5505 | Recruiting | Vila Clementino | Brazil |
| Site Number - 5601 | Recruiting | Pleven | Bulgaria |
| Site Number - 5600 | Recruiting | Sofia | Bulgaria |
| Site Number - 5602 | Recruiting | Sofia | Bulgaria |
| Site Number - 5603 | Recruiting | Sofia | Bulgaria |
| Site Number - 5604 | Recruiting | Sofia | Bulgaria |
| Site Number - 5800 | Not yet recruiting | Bogotá | Colombia |
| Site Number - 3600 | Recruiting | Copenhagen | Denmark |
| Site Number - 3601 | Recruiting | Odense | Denmark |
| Site Number - 7251 | Recruiting | Tallinn | Estonia |
| Site Number - 3800 | Recruiting | Turku | Finland |
| Site Number - 6505 | Not yet recruiting | Berlin | Germany |
| Site Number - 6501 | Recruiting | Bochum | Germany |
| Site Number - 6504 | Not yet recruiting | Essen | Germany |
| Site Number - 6500 | Not yet recruiting | Tübingen | Germany |
| Site Number - 6503 | Recruiting | Ulm | Germany |
| Site Number - 6502 | Recruiting | Würzburg | Germany |
| Site Number - 3901 | Recruiting | Alexandroupoli | Greece |
| Site Number - 3902 | Recruiting | Athens | Greece |
| Site Number - 3905 | Recruiting | Chaïdári | Greece |
| Site Number - 3906 | Not yet recruiting | Heraklion | Greece |
| Site Number - 3903 | Not yet recruiting | Ioannina | Greece |
| Site Number - 3904 | Recruiting | Larissa | Greece |
| Site Number - 3900 | Recruiting | Pátrai | Greece |
| Site Number - 7551 | Not yet recruiting | Budapest | Hungary |
| Site Number - 7550 | Recruiting | Kistarcsa | Hungary |
| Site Number - 7552 | Recruiting | Pécs | Hungary |
| Site Number - 4100 | Not yet recruiting | Waterford | Ireland |
| Site Number - 6004 | Recruiting | Bergamo | Italy |
| Site Number - 6007 | Recruiting | Bologna | Italy |
| Site Number - 6000 | Recruiting | Brescia | Italy |
| Site Number - 6009 | Recruiting | Milan | Italy |
| Site Number - 6001 | Recruiting | Milan | Italy |
| Site Number -6005 | Recruiting | Milan | Italy |
| Site Number - 6011 | Recruiting | Pavia | Italy |
| Site Number - 6010 | Not yet recruiting | Pisa | Italy |
| Site Number - 6002 | Not yet recruiting | Roma | Italy |
| Site Number - 6006 | Recruiting | Roma | Italy |
| Site Number - 6003 | Recruiting | Siena | Italy |
| Site Number - 2603 | Not yet recruiting | Colonia del Valle | Mexico |
| Site Number - 2600 | Not yet recruiting | Culiacán | Mexico |
| Site Number - 2602 | Not yet recruiting | Tlalpan | Mexico |
| Site Number - 2601 | Not yet recruiting | Veracruz | Mexico |
| Site Number - 2200 | Recruiting | Utrecht | Netherlands |
| Site Number - 2300 | Recruiting | Oslo | Norway |
| Site Number - 2401 | Not yet recruiting | Callao | Peru |
| Site Number - 2400 | Not yet recruiting | Lima | Peru |
| Site Number - 3009 | Recruiting | Lublin | Lublin Voivodeship | Poland |
| Site Number - 3007 | Recruiting | Bydgoszcz | Poland |
| Site Number - 3008 | Not yet recruiting | Gdansk | Poland |
| Site Number - 3004 | Recruiting | Katowice | Poland |
| Site Number - 3000 | Recruiting | Krakow | Poland |
| Site Number - 3003 | Recruiting | Krakow | Poland |
| Site Number - 3001 | Recruiting | Lublin | Poland |
| Site Number - 3005 | Recruiting | Lublin | Poland |
| Site Number - 3002 | Recruiting | Poznan | Poland |
| Site Number - 3006 | Not yet recruiting | Warsaw | Poland |
| Site Number -2902 | Recruiting | Almada | Portugal |
| Site Number - 2901 | Recruiting | Matosinhos Municipality | Portugal |
| Site Number - 2903 | Recruiting | Vila Nova de Gaia | Portugal |
| Site Number - 7503 | Not yet recruiting | Bucharest | Romania |
| Site Number - 7500 | Recruiting | Constanța | Romania |
| Site Number - 9000 | Recruiting | Belgrade | Serbia |
| Site Number - 9003 | Recruiting | Belgrade | Serbia |
| Site Number -9002 | Recruiting | Kragujevac | Serbia |
| Site Number - 9001 | Recruiting | Niš | Serbia |
| Site Number - 2800 | Not yet recruiting | Martin | Slovakia |
| Site Number - 2802 | Recruiting | Prešov | Slovakia |
| Site Number - 2801 | Recruiting | Rimavská Sobota | Slovakia |
| Site Number - 7351 | Recruiting | Ljubljana | Slovenia |
| Site Number - 7100 | Recruiting | Barcelona | Spain |
| Site Number - 7101 | Recruiting | Barcelona | Spain |
| Site Number - 7104 | Not yet recruiting | Bilbao | Spain |
| Site Number - 7103 | Recruiting | Córdoba | Spain |
| Site Number - 7102 | Recruiting | Santiago de Compostela | Spain |
| Site Number - 7105 | Recruiting | Valencia | Spain |
| Site Number - 4250 | Not yet recruiting | Bakırköy | Turkey (Türkiye) |
| Site Number - 4253 | Not yet recruiting | Başakşehir | Turkey (Türkiye) |
| Site Number - 4255 | Recruiting | Bursa | Turkey (Türkiye) |
| Site Number - 4251 | Not yet recruiting | Istanbul | Turkey (Türkiye) |
| Site Number - 4254 | Recruiting | Izmir | Turkey (Türkiye) |
| Site Number - 4252 | Recruiting | Samsun | Turkey (Türkiye) |
| Site Number - 7001 | Recruiting | Bristol | United Kingdom |
| Site Number - 7002 | Not yet recruiting | Glasgow | United Kingdom |
| Site Number - 7000 | Recruiting | Salford | United Kingdom |
| Site Number - 7003 | Recruiting | Southampton | United Kingdom |
| ID | Term |
|---|---|
| D020277 | Polyradiculoneuropathy, Chronic Inflammatory Demyelinating |
| ID | Term |
|---|---|
| D011129 | Polyradiculoneuropathy |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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