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This is an open-label extension (OLE) study designed to evaluate the long-term safety and tolerability of batoclimab in participants with CIDP who have completed Study IMVT-1401-2401 (NCT05581199). In this study, participants will receive 340 mg of batoclimab subcutaneously (SC) once weekly (QW) for up to 52 weeks. Upon completion of the Week 52 or early termination (ET) Visit, participants will transition into the 4-week Follow-up Period, which concludes with a Follow-up Visit approximately 28 (± 7) days after the Week 52 or ET Visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Batoclimab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Batoclimab | Drug | Batoclimab 340 mg SC QW |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Treatment Discontinuation | Up to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Adjusted inflammatory Neuropathy Cause and Treatment (aINCAT) | The INCAT disability scale is a widely used and validated efficacy assessment of neurologic dysfunction in CIDP and will be used for measurement of clinical response. | Up to 52 weeks |
| Change from Baseline in Mean Grip Strength |
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Inclusion Criteria:
Exclusion Criteria:
Note: Other protocol specified criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Number - 1621 | New Haven | Connecticut | 06519 | United States | ||
| Site Number - 1617 |
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Mean Grip strength provides an objective, quantitative and immediate assessment of strength impairment. |
| Up to 52 weeks |
| Ormond Beach |
| Florida |
| 32174 |
| United States |
| Site Number - 1611 | Nicholasville | Kentucky | 40356 | United States |
| Site Number - 1610 | Charlotte | North Carolina | 28207 | United States |
| Site Number - 1601 | Austin | Texas | 78759 | United States |
| Site Number - 7753 | Rosario | Santa Fe Province | S2000BZL | Argentina |
| Site Number - 7751 | Rosario | Santa Fe Province | S2000DTP | Argentina |
| Site Number - 7750 | Buenos Aires | C1199ABB | Argentina |
| Site Number - 7752 | San Miguel de Tucumán | T4000AXL | Argentina |
| Site Number - 4680 | Leuven | Vlaams Brabant | 3000 | Belgium |
| Site Number - 9103 | Brasília | Federal District | 70200-730 | Brazil |
| Site Number - 9101 | Curitiba | Paraná | 81210-310 | Brazil |
| Site Number - 9100 | Ribeirão Preto | São Paulo | 14048-900 | Brazil |
| Site Number - 6702 | Leipzig | Saxony | 04103 | Germany |
| Site Number - 6341 | Pátrai | Achaïa | 265 04 | Greece |
| Site Number - 6344 | Athens | Attica | 115 25 | Greece |
| Site Number - 6347 | Larissa | 41110 | Greece |
| Site Number - 6305 | Bologna | Emilia-Romagna | 40139 | Italy |
| Site Number - 6309 | Rome | Lazio | 00133 | Italy |
| Site Number - 6307 | Milan | Lombardy | 20132 | Italy |
| Site Number - 3207 | Poznan | Greater Poland Voivodeship | 61-731 | Poland |
| Site Number - 3208 | Krakow | Lesser Poland Voivodeship | 30-688 | Poland |
| Site Number - 3209 | Krakow | Lesser Poland Voivodeship | 31-202 | Poland |
| Site Number - 3210 | Lublin | Lublin Voivodeship | 20-064 | Poland |
| Site Number - 3206 | Lublin | Lublin Voivodeship | 20-701 | Poland |
| Site Number - 3201 | Katowice | Silesian Voivodeship | 40-123 | Poland |
| Site Number - 8403 | Timișoara | Timiș County | 300736 | Romania |
| Site Number - 8400 | Constanța | 900591 | Romania |
| Site Number - 8501 | Belgrade | 11000 | Serbia |
| Site Number - 8603 | Prešov | 081 81 | Slovakia |
| ID | Term |
|---|---|
| D020277 | Polyradiculoneuropathy, Chronic Inflammatory Demyelinating |
| D001327 | Autoimmune Diseases |
| 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 |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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