A Phase 2b Study to Assess the Safety and tolerability of Batoclimab in Patients with CIDP
Key facts
- Where
- Cracow, Katowice, Lublin és Poznan, LengyelországSee the 7 sites
- Phase
- 2. fázis
Where in Lengyelország
- Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla IICracow, LengyelországNo longer taking part
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W KrakowieCracow, LengyelországNo longer taking part
- Neurologia Śląska Centrum MedyczneKatowice, LengyelországNo longer taking part
- Centrum Medyczne Hope Clinic Sebastian SzklenerLublin, LengyelországNo longer taking part
- Clinirem Sp. z o.o.Lublin, LengyelországNo longer taking part
- Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p.Lublin, LengyelországNo longer taking part
- Clinical Research Center Sp z o o Medic R Sp kPoznan, LengyelországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Immunovant Sciences GmbH
- Trial code
- EU 2024-518364-12-00
- Record updated
- 2025. augusztus 20.
- Original description
To evaluate the long-term safety and tolerability of batoclimab in participants with CIDPRead 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)
To evaluate the long-term safety and tolerability of batoclimab in participants with CIDP
Inclusion: Any participant who has completed Study IMVT-1401-2401; in the event that Study IMVT-1401-2401 is prematurely terminated for reasons that do not affect the benefit:risk profile, any participant that may benefit from continued access to batoclimab in the opinion of the Investigator; Female participants of childbearing potential must agree to use a highly effective method of birth control from the signing of informed consent until 90 days after the last dose of study treatment; 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; Are willing and capable of giving written informed consent, which includes being able to comply with all aspects of the study treatment and testing schedule. For participants who wish to avail themselves of the option for at-home study treatment administration, this includes the ability to receive or self-administer study treatment at home or outside of the study site clinic.
Exclusion: Participant has received Standard of Care therapy for treatment of a relapse in Study IMVT-1401-2401; 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 subject 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.