Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 20.0 Level: LLT Classification code 10077384 Term: Chronic inflammatory demyelinating polyneuropathy System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: Batoclimab
Product Code: IMVT-1401
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Batoclimab
CAS Number: 2187430-05-1
Current Sponsor code: IMVT
HL161BKN
HBM9161
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: range
Concentration number: 155 - 185-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Ro
Sponsors
Immunovant Sciences, GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Note: Eligible participants will be assigned to one of four cohorts (A, B, C, and D) based upon their baseline CIDP treatment and whether they meet diagnosis according to the European Academy of Neurology/Peripheral Nerve Society (EAN/PNS) criteria (Cohorts A, B, and C) or clinical criteria only (Cohort D) at the time of screening. All Cohorts: 1. Are >= 18 years at the Screening Visit. 2. 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 EAN/PNS Guideline on Diagnosis and Treatment of CIDP. Clinical criteria for typical CIDP and variants are as follows (either criterion must be met): a. 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 b. 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 Cohorts A and B: 3. Have electrodiagnostic test results supporting the diagnosis of CIDP in accordance with the EAN/PNS Guideline on Diagnosis and Treatment of CIDP; for Cohorts A and B, either criteria must be met: a. Motor nerve conduction criteria strongly supportive of demyelination. b. 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 > 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. Cohort C only: 4. Have a diagnosis of CIDP in accordance with the EAN/PNS Guideline on Diagnosis and Treatment of CIDP based on clinical criteria and motor nerve conduction criteria strongly supportive of demyelination (i.e., motor nerve conduction criteria weakly supportive of demyelination is insufficient diagnostic evidence for admission to Cohort C). Cohort D only: 5. Have met only clinical diagnostic criteria for typical CIDP, or one of the following CIDP variants: multifocal CIDP, focal CIDP, or motor CIDP in accordance with the EAN/PNS Guideline on Diagnosis and Treatment of CIDP. Either inclusion criterion 2(a) or 2(b) must be met. Additional inclusion criteria are defined in the protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 250 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 27
Exclusion criteria
Exclusion criteria: All Cohorts: 1. Have current or prior history of immunoglobulin M (IgM) paraproteinemia with or without anti-myelin-associated-glycoprotein antibodies. 2. Have Distal CIDP, Sensory CIDP or are suspected of having a diagnosis of auto-immune nodopathy in accordance with the EAN/PNS Guideline on Diagnosis and Treatment of CIDP. 3. Have polyneuropathy of causes other than CIDP including but not limited to: a. Multifocal motor neuropathy b. Hereditary demyelinating neuropathy c. Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin change syndromes (i.e., POEMS) d. Lumbosacral radiculoplexus neuropathy e. Systemic illnesses including vitamin deficiency syndromes and paraneoplastic neuropathies f. Drug- or toxin-induced 4. Have diabetes mellitus (DM) and meets any of the following criteria: a. Does not meet inclusion criteria 2(a) and 3(a). b. In the opinion of the Investigator, there is evidence of poorly controlled DM preceding the diagnosis of CIDP. c. 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 receiving chronic oral corticosteroids monotherapy at a dose > 40 mg/day prednisolone/prednisone or its equivalent at the Screening Visit. 7. Are receiving chronic oral corticosteroid at a dose > 10 mg/day prednisolone/prednisone or equivalent in combination with immunoglobulin therapy or PLEX at the Screening Visit. Additional exclusion criteria are defined in the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Period 2/ Cohort A: To evaluate the efficacy of batoclimab compared to placebo in maintaining clinical response as assessed by adjusted inflammatory neuropathy cause and treatment (Adj INCAT) score in participants receiving immune globulin (IVIg or SCIg) or plasma exchange (PLEX) treatment for CIDP at the time of screening;Secondary Objective: Period 2/ Cohort A: -To evaluate the efficacy of batoclimab compared to placebo in maintaining clinical response in participants receiving immune globulin (IVIg or SCIg) or PLEX treatment for CIDP at the time of screening Period 2/ Cohort A and B combined: -To evaluate the efficacy of batoclimab compared to placebo in maintaining clinical response in participants receiving any CIDP treatment at the time of screening Period 2/ Cohorts A, B and C combined: -To evaluate the efficacy of batoclimab compared to placebo in maintaining clinical response regardless of CIDP treatment history ;Primary end point(s): Period 2/ Cohort A: Proportion of participants who remain relapse-free at Week 36 where relapse is defined as a worsening (increase) of = 1 point on the Adj INCAT score at any time point during Period 2 relative to Period 2 baseline which is sustained at a Follow-Up visit 1 week later.;Timepoint(s) of evaluation of this end point: Week 36 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Period 2/ Cohort A: -Time to first relapse relative to Period 2 baseline - Change from Period 2 baseline to Week 36 in: o Adj INCAT score o Inflammatory Rasch-built Overall Disability Scale (I-RODS) o Mean Grip Strength o Medical Research Council (MRC) Sum Score o Overall Neuropathy Limitations Scale (ONLS) Period 2/ Cohort A and B combined: -Change from Period 2 baseline to Week 36 in: o Adj INCAT score o I-RODS o Mean Grip Strength o MRC Sum Score o ONLS Period 2/ Cohorts A, B and C combined: -Proportion of participants who remain relapse-free at Week 36;Timepoint(s) of evaluation of this end point: Week 36 | — |
Countries
Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, Denmark, Finland, Germany, Greece, Ireland, Italy, Korea, Republic of, Netherlands, Norway, Peru, Poland, Portugal, Romania, Serbia, Slovakia, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactCentral Study Contact
Immunovant Sciences, GmbH
Outcome results
None listed