2024-518364-12-00CompletedPhase 2
A Phase 2b Study to Assess the Safety and tolerability of Batoclimab in Patients with CIDP
An Open-Label Extension Study to Assess Long-term Safety and Tolerability of Batoclimab in Adult Participants with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 20 Aug 2025
Brief summary (registry, in English)
To evaluate the long-term safety and tolerability of batoclimab in participants with CIDP
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 35 (actual)
- First submitted
- 27 Nov 2024
- Start date
- 9 May 2025
- Lead sponsor
- Immunovant Sciences GmbH
- EU CT number
- 2024-518364-12-00
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 35
- 21 sites in 10 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participant has received Standard of Care therapy for treatment of a relapse in Study IMVT-1401-2401.
Other illness
- 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.
Other
- Participant intends to have a live vaccination during the course of the study or within 7 weeks following the final dose of batoclimab.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (21)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UZ Leuven | Leuven | Belgium | Completed |
| Military Medical Academy | Pleven | Bulgaria | Completed |
| Universitaet Leipzig | Leipzig | Germany | Completed |
| Rigshospitalet | Copenhagen Oe | Denmark | Completed |
| 401 General Military Hospital of Athens | Athens | Greece | Completed |
| General University Hospital of Larissa | Larissa | Greece | Completed |
| General University Hospital Of Patras | Patras | Greece | Completed |
| Azienda Unita Sanitaria Locale Di Bologna | Bologna | Italy | Completed |
| San Raffaele Ospedale | Milano | Italy | Completed |
| Fondazione PTV - POLICLINICO TOR VERGATA | Roma | Italy | Completed |
| Oslo University Hospital HF | Oslo | Norway | Completed |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie | Cracow | Poland | Completed |
| Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II | Cracow | Poland | Completed |
| Neurologia Śląska Centrum Medyczne | Katowice | Poland | Completed |
| Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p. | Lublin | Poland | Completed |
| Clinirem Sp. z o.o. | Lublin | Poland | Completed |
| Centrum Medyczne Hope Clinic Sebastian Szklener | Lublin | Poland | Completed |
| Clinical Research Center Sp z o o Medic R Sp k | Poznan | Poland | Completed |
| Brainaxy Clinic S.R.L. | Constanta | Romania | Completed |
| Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara | Timisoara | Romania | Completed |
| Fakultna nemocnica s poliklinikou J.A. Reimana Presov | Prešov | Slovakia | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.