An Open-Label Extension Study to Assess Long-term Safety and Tolerability of Batoclimab in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Por invitaciónFase 2ClinicalTrials.gov

ID: NCT07188844Tipo: INTERVENTIONALInicio: 28 de ago de 2025Fin estimado: 1 de nov de 2028

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Any participant who has completed Study IMVT-1401-2401
Female participants of childbearing potential must agree to use a highly effective method of birth control
Female participants must agree not to donate eggs throughout the study and for 90 days after the final study treatment administration
Male participants must agree to use 1 highly effective contraception method with partners of childbearing potential throughout the study period and for 90 days after the final study treatment administration
Male participants must agree not to donate sperm throughout the study period and for 90 days after the final study treatment administration
Agree not to participate in another interventional study while on treatment

Criterios de exclusión

Participant has any medical condition (acute or chronic illness) or psychiatric condition, including autoimmune disease or neurologic disease other than CIDP, or known history of drug or alcohol abuse that, in the opinion of the Investigator, could jeopardize the participant's ability to participate in this study, compromise accurate assessment of CIDP symptoms or otherwise interfere with the course and conduct of the study.
Participant intends to have a live vaccination during the course of the study or within 7 weeks following the final dose of batoclimab
Participant has an ongoing SAE or a medical condition in the IMVT-1401-2401 study that the Investigator considers putting the participant at a significantly increased risk of participating in Study IMVT-1401-2402
Participant has received Standard of Care therapy for treatment of a relapse in Study IMVT-1401-2401
Note: Other protocol specified criteria may apply.

Intervenciones

drug

Batoclimab

Batoclimab 340 mg SC QW

Ubicaciones

Site Number - 7753

Rosario, Santa Fe Province, Argentina

Site Number - 7751

Rosario, Santa Fe Province, Argentina

Site Number - 7750

Buenos Aires, Argentina

Site Number - 7752

San Miguel de Tucumán, Argentina

Patrocinadores

PrincipalImmunovant Sciences GmbH

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