A Phase 2b Study of IMVT-1402 Treatment in 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] - Immune System Diseases [C20]

Trial duration

28 Nov 2025 → ongoing

Decision date (initial)

2025-11-03

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

External identifiers

EU CT number

2024-517614-14-00

ClinicalTrials.gov

NCT07032662

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic, Safety, Pharmacokinetic, Efficacy, Pharmacogenetic, Therapy

To evaluate the efficacy of IMVT-1402 compared to placebo in preventing Relapse as assessed by aINCAT score.

Secondary objectives 4

1. To evaluate the efficacy of IMVT-1402 compared to placebo as assessed by I-RODS.
2. To evaluate the efficacy of IMVT-1402 compared to placebo as assessed by Mean Grip Strength.
3. To evaluate the efficacy of IMVT-1402 compared to placebo as assessed by MRC-SS.
4. To evaluate the efficacy of IMVT-1402 compared to placebo as assessed by aINCAT score.

Conditions and MedDRA coding

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Are ≥ 18 years of age at the time of signing the informed consent form (ICF).
2. Have met clinical diagnostic criteria for typical CIDP or one of the following CIDP variants: multifocal CIDP or motor CIDP per the 2021 European Academy of Neurology/Peripheral Nerve Society (EAN/PNS) Guideline on Diagnosis and Treatment of CIDP.
3. Have electrodiagnostic test results supporting the diagnosis of CIDP per the EAN/PNS guideline on diagnosis and treatment of CIDP.
4. Are currently on, and have been receiving, chronic, stable doses of systemic corticosteroids (i.e., daily or every other day oral or pulse regimen), or immunoglobulin therapy (intravenous immunoglobulin [IVIg] or subcutaneous immunoglobulin [SCIg]) ± low dose oral corticosteroids, for at least 3 months for the treatment of CIDP at the time of the Screening Visit.

Exclusion criteria 6

1. Have current or prior history of IgM paraproteinemia with or without antimyelin-associated-glycoprotein antibodies.
2. Have distal, sensory, or focal CIDP, or have a diagnosis of autoimmune nodopathy per the EAN/PNS guideline on diagnosis and treatment of CIDP.
3. Have polyneuropathy with etiology other than CIDP including but not limited to: • Multifocal motor neuropathy • Hereditary demyelinating neuropathy • Polyneuropathy, organomegaly, endocrinopathy, or monoclonal protein and skin change syndromes • Lumbosacral radiculoplexus neuropathy • Systemic illnesses, including vitamin deficiency syndromes and paraneoplastic neuropathies • Drug- or toxin-induced
4. Have diabetes mellitus (DM) and meets any of the following criteria: • Does not have both typical CIDP and strong evidence of demyelination on nerve conduction study. • In the opinion of the Investigator, there is evidence of poorly controlled DM immediately preceding the diagnosis of CIDP. • In the opinion of the Investigator, there is evidence of poorly controlled DM at Screening.
5. Have a history of myelopathy or evidence of central demyelination.
6. Are breastfeeding or pregnant as determined by a positive serum pregnancy test at the Screening Visit or urine human chorionic gonadotropin test at the Baseline Visit (Day 1).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The proportion of participants remaining Relapse-free by Week 24.

Secondary endpoints 4

1. Change from baseline to Week 24 in I-RODS.
2. Change from baseline to Week 24 in Mean Grip Strength in the dominant hand.
3. Change from baseline to Week 24 in MRC-SS.
4. Change from baseline to Week 24 in aINCAT score.

Investigational products

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

Test 1

Placebo 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 23

Locations

19 EU/EEA countries · 58 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 429 files

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

Application history

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