Chronic Inflammatory Demyelinating Polyneuropathy
Conditions
Interventions
In part A (a 24-week double-blinded treatment period), participants will be randomized to the empasiprubart group or the IVIg group in a 1:1 ratio to 1 of 2 arms. In empasiprubart group, empasiprubart
Sponsors
Kamino Eriko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Is at least 18 years of age and the local legal age of consent for clinical studies when signing the ICF 2. Meets criteria for CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021) 3. Has either typical CIDP or 1 of the following CIDP variants: motor CIDP, multifocal CIDP (also known as Lewis-Sumner syndrome), focal CIDP, or distal CIDP 4. Has responded to IVIg in the past 5 years 5. Receiving treatment with IVIg within a standard maintenance dosing regimen, defined as 0.4 to 2 g/kg body weight once every 2 to 6 weeks 6. Receiving a minimum weekly IVIg dose of >=0.125 g/kg body weight 7. Receiving a stable optimal maintenance regimen of IVIg (as assessed by the principal or treating investigator with no change in dose >10% [g/kg body weight] and no change in dose frequency) for >=12 weeks before screening until baseline 8. Has documented vaccinations against encapsulated bacterial pathogens (Neisseria meningitidis and Streptococcus pneumoniae) within 5 years of screening or is willing to receive immunization at least 14 days before the first IMP administration 9. Has residual disability, defined as an INCAT score of >=2 to 9 at screening that is confirmed at baseline. 10. Has active disease, with a CIDP disease activity status (CDAS) of >=3 points at screening
Exclusion criteria
Exclusion criteria: 1. Polyneuropathy of other causes, including but not limited to hereditary demyelinating neuropathies, neuropathies secondary to infection or systemic disease, diabetic neuropathy, drug- or toxin-induced neuropathies, MMN, polyneuropathy related to IgM monoclonal gammopathy, polyneuropathy-organomegaly-endocrinopathy-monoclonal gammopathy-skin changes syndrome (POEMS syndrome), or lumbosacral radiculoplexus neuropathy 2. Besides the indication under study, known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of CIDP or puts the participant at undue risk 3.Meets the criteria for possible or sensory CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021) 4.Use of other long-acting immunomodulatory treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of >= 1 point compared with baseline in aINCAT score at week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change from baseline in I-RODS centile points score at week 24 - Change from baseline in MRC-SS at week 24 - Change from baseline in grip strength (3-day moving average) in the dominant hand at week 24 - Time to reduction of >=1 point from baseline in aINCAT score - Change from baseline in TUG at week 24 - Time to increase of >=1 point compared with baseline in aINCAT score - Change from baseline in grip strength (3-day moving average) of both hands over time - Change from baseline in grip strength (daily average) for both hands - Change from baseline in MRC-SS over time - Change from baseline in aINCAT over time - Change from baseline in EQ-5D-5L over time - Change from baseline in RT-FSS over time - Change from baseline in SF-12 over time - Change from baseline in BPI-SF over time - PGI-S values over time - PGI-C values over time - Values for work-related and household chore activities of the HRPQ - Percentage of scheduled hours lost in total (absenteeism+presenteeism) - Change from baseline in I-RODS centile points score over time - Change from baseline in TUG over time - Incidence of antidrug antibodies against empasiprubart in serum - Incidence of neutralizing antibodies against empasiprubart in serum - Incidence of (serious) adverse events - Percentage change from baseline in free C2 and total C2 over time - Serum concentrations of empasiprubart over time | — |
Countries
Argentina, Australia, Austria, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Israel, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Korea, Spain
Contacts
Public ContactEriko Kamino
PPD-SNBL K.K.
Outcome results
None listed