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A Phase 2b Study to Assess the Safety and tolerability of Batoclimab in Patients with CIDP
EU CTIS ID: 2024-518364-12-00
What this study is testing
To evaluate the long-term safety and tolerability of batoclimab in participants with CIDP
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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 subject 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.
See the full eligibility criteria
- 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.
- 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 subject 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.
The study team makes the final eligibility decision.
Where it's taking place
- Brazil
- Argentina
- Serbia
- United Kingdom
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brazil; Argentina; Serbia; United Kingdom; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.