An Open-Label Extension Study of Batoclimab in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Megadott ok: Sponsor Decision
Key facts
- Where
- Katowice, Krakow, Lublin és Poznan, LengyelországSee the 6 sites
- Phase
- 2. fázis
Where in Lengyelország
- KatowiceKatowice, LengyelországNo longer taking part
- KrakowKrakow, LengyelországNo longer taking part
- KrakowKrakow, LengyelországNo longer taking part
- LublinLublin, LengyelországNo longer taking part
- LublinLublin, LengyelországNo longer taking part
- PoznanPoznan, LengyelországNo longer taking part
Trial details
- Who runs it
- Immunovant Sciences GmbH
- Trial code
- NCT07188844
- Record updated
- 2026. augusztus 11.
- Original description
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.Read full original descriptionShow less
An Open-Label Extension Study to Assess Long-term Safety and Tolerability of Batoclimab in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
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.
Inclusion: 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.
Exclusion: Participant has received Standard of Care therapy for treatment of a relapse in Study IMVT-1401-2401; Note: Other protocol specified criteria may apply; 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 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 intends to have a live vaccination during the course of the study or within 7 weeks following the final dose of batoclimab.