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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

Next steps

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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (21)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
UZ LeuvenLeuvenBelgiumCompleted
Military Medical AcademyPlevenBulgariaCompleted
Universitaet LeipzigLeipzigGermanyCompleted
RigshospitaletCopenhagen OeDenmarkCompleted
401 General Military Hospital of AthensAthensGreeceCompleted
General University Hospital of LarissaLarissaGreeceCompleted
General University Hospital Of PatrasPatrasGreeceCompleted
Azienda Unita Sanitaria Locale Di BolognaBolognaItalyCompleted
San Raffaele OspedaleMilanoItalyCompleted
Fondazione PTV - POLICLINICO TOR VERGATARomaItalyCompleted
Oslo University Hospital HFOsloNorwayCompleted
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W KrakowieCracowPolandCompleted
Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla IICracowPolandCompleted
Neurologia Śląska Centrum MedyczneKatowicePolandCompleted
Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p.LublinPolandCompleted
Clinirem Sp. z o.o.LublinPolandCompleted
Centrum Medyczne Hope Clinic Sebastian SzklenerLublinPolandCompleted
Clinical Research Center Sp z o o Medic R Sp kPoznanPolandCompleted
Brainaxy Clinic S.R.L.ConstantaRomaniaCompleted
Spitalul Clinic Judetean De Urgenta Pius Brinzeu TimisoaraTimisoaraRomaniaCompleted
Fakultna nemocnica s poliklinikou J.A. Reimana PresovPrešovSlovakiaCompleted

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This page is information, not medical advice. Discuss any trial with your doctor.