To Assess Efficacy and Safety of Batoclimab in Adult Participants With Active CIDP

• Status: Not yet recruiting
• Trial end date: 2027-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multi-center, randomized, quadruple-blind, placebo-controlled study to evaluate the efficacy and safety of batoclimab in adult participants with active CIDP. The study includes a 4-week Screening Phase, an up to 12-week Washout Phase, a 12-week Randomized Treatment Phase (Period 1), an up to 24-week Randomized Withdrawal Phase (Period 2), a 4-week Safety follow-up for participants not entering Long-Term Extension (LTE), and a 52-week LTE Phase. The total study duration will be up to 104 weeks. Eligible participants will be assigned to one of three cohorts (A, B, C) based upon their CIDP treatment at the time of screening.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Immunovant Sciences GmbH

Criteria

Inclusion Criteria:

• Are >= 18 years at the Screening Visit.

• Have met clinical diagnostic criteria for typical CIDP, or one of the following CIDP variants: multifocal CIDP, focal CIDP, or motor CIDP in accordance with the European Academy of Neurology/Peripheral Nerve Society (EAN/PNS) Guideline on the Diagnosis and Treatment of CIDP. Clinical criteria for typical CIDP and variants are as follows (either criteria must be met):

1. Typical CIDP: All the following:

• Progressive or relapsing, symmetric, proximal, and distal muscle weakness of upper and lower limbs, and sensory involvement of at least two limbs (at any point in the disease course)

• Developing over at least 8 weeks

• Absent or reduced tendon reflexes in all limbs

2. CIDP variants: One of the following, but otherwise as in typical CIDP (tendon reflexes may be normal in unaffected limbs):

• Multifocal CIDP: documented sensory loss and muscle weakness in a multifocal pattern, usually asymmetric, upper limb predominant

• Focal CIDP: sensory loss and muscle weakness in only one limb

• Motor CIDP: motor symptoms and signs without sensory involvement

• Have electrodiagnostic test results supporting the diagnosis of CIDP in accordance with the EAN/PNS Guideline on the Diagnosis and Treatment of CIDP (either criteria must be met):

1. Motor nerve conduction criteria strongly supportive of demyelination.

2. Motor nerve conduction criteria weakly supportive of demyelination and 2 or more of the following additional diagnostic criteria:

• Objective improvement to an empiric trial of therapy with immunoglobulin treatment, plasma exchange (PLEX) or corticosteroids.

• Diagnostic imaging by ultrasound or magnetic resonance imaging (MRI) supporting the diagnosis of CIDP by demonstrating nerve enlargement.

• Cerebrospinal fluid (CSF) demonstrating albuminocytologic dissociation (i.e., elevated CSF protein level [defined as > 70 milligrams per deciliter {mg/dL} or more than 10 mg/dL greater than years of age for those aged 60 years and over] with normal CSF white blood cell [WBC] level).

• Nerve biopsy demonstrating features supporting the diagnosis of CIDP such as edema, demyelination, and/or onion bulb formation.

Additional inclusion criteria are defined in the protocol.

Exclusion Criteria:

• Have presence of immunoglobulin M (IgM) paraproteinemia with or without anti-myelin-associated-glycoprotein antibodies.

• Have Distal CIDP, Sensory CIDP or are suspected of having a diagnosis of auto-immune nodopathy in accordance with the EAN/PNS Guideline on the Diagnosis and Treatment of CIDP.

• Have polyneuropathy of causes other than CIDP including but not limited to:

1. Multifocal motor neuropathy

2. Hereditary demyelinating neuropathy

3. Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin change syndromes (i.e., POEMS)

4. Lumbosacral radiculoplexus neuropathy

5. Systemic illnesses including vitamin deficiency syndromes and paraneoplastic neuropathies

6. Drug- or toxin-induced

• Have diabetes mellitus (DM) and meets any of the following criteria:

1. Diagnosis of DM pre-dates the diagnosis of CIDP

2. Has ever required daily insulin therapy

3. Duration of DM is 5 years or greater

4. Has evidence of microvascular complications of DM including retinopathy or nephropathy

• Have a history of myelopathy or evidence of central demyelination.

• Are receiving chronic oral corticosteroids monotherapy at a dose > 40 mg/day or < 20 mg/day prednisolone/prednisone or its equivalent at the Screening Visit.

• Are receiving chronic oral corticosteroid at a dose > 10 mg/day prednisone or equivalent in combination with immunoglobulin therapy or PLEX at the Screening Visit.

Additional exclusion criteria are defined in the protocol.