A Phase 2b Study to Assess the Safety and tolerability of Batoclimab in Patients with CIDP

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Immunovant Sciences GmbH

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

9 May 2025 → 18 Apr 2026

Decision date (initial)

2025-04-01

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Pharmacokinetic, Pharmacodynamic, Safety, Efficacy

To evaluate the long-term safety and tolerability of batoclimab in participants with CIDP

Secondary objectives 1

1. To evaluate the long-term clinical efficacy of batoclimab in participants with CIDP.

Conditions and MedDRA coding

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. 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.
2. 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.
3. Female participants must agree not to donate eggs throughout the study and for 90 days after the final study treatment administration.
4. 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.
5. Male participants must agree not to donate sperm throughout the study period and for 90 days after the final study treatment administration.
6. Agree not to participate in another interventional study while on treatment.
7. 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 criteria 4

1. 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.
2. Participant intends to have a live vaccination during the course of the study or within 7 weeks following the final dose of batoclimab.
3. 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.
4. Participant has received Standard of Care therapy for treatment of a relapse in Study IMVT-1401-2401.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of participants with TEAEs, SAEs, and TEAEs leading to study treatment discontinuation.

Secondary endpoints 1

1. Change from baseline over time in the following scores: • Adjusted INCAT • Mean Grip Strength

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Immunovant Sciences GmbH

Sponsor organisation

Immunovant Sciences GmbH

Address

Viaduktstrasse 8

City

Basel Town

Postcode

4051

Country

Switzerland

Scientific contact point

Organisation

Immunovant Sciences GmbH

Contact name

Immunovant Clinical Trials

Public contact point

Organisation

Immunovant Sciences GmbH

Contact name

Immunovant Clinical Trials

Third parties 16

Locations

10 EU/EEA countries · 21 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 74 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications