Chronic Inflammatory Demyelinating Polyneuropathy
Conditions
Interventions
In part A (a 24-week double-blinded treatment period), participants will be randomized to the empasiprubart IV group or the placebo group in a 2:1 ratio to 1 of 2 arms. In part B (a 24-month open-labe
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 European Academy of Neurology (EAN)/ Peripheral Nerve Society (PNS) Task Force CIDP guidelines, second revision (2021) 3. Has either typical CIDP or 1 of the following CIDP variants: motor CIDP (including motor-predominant CIDP), multifocal CIDP (also known as Lewis-Sumner syndrome), focal CIDP, or distal CIDP 4. Has active disease, with a CIDP disease activity status (CDAS) of >=2 points at screening 5. Has residual disability, defined as an Inflammatory Neuropathy Cause and Treatment (INCAT) score of >=2 to 9 at screening that is confirmed at baseline. 6. Fulfills any of the following CIDP treatment regimens: a. CIDP treatment-naive: Without previous treatment for CIDP b. Stopped CIDP treatment: Has not received treatment with corticosteroids, immunoglobulins, plasma exchange (PLEX), or FcRn inhibitors for >=3 months before screening c. Receiving CIDP treatment: Currently (ie, within 3 months before the screening visit) treated with pulsed or oral corticosteroids, immunoglobulins, PLEX, or FcRn inhibitors. Therapeutic escalations of these medications are prohibited during screening. Participants already receiving CIDP treatment will have to discontinue their CIDP treatment before first IMP administration and must be willing to switch to the study IMP. 7. Has documented vaccinations against encapsulated bacterial pathogens (N meningitidis and S pneumoniae) within 5 years of screening or receives immunization at least 14 days before the first IMP administration
Exclusion criteria
Exclusion criteria: 1. Meets the criteria for possible or sensory CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021) 2. 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 3. 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 4. Clinical diagnosis of systemic lupus erythematosus (SLE) 5. Use of other long-acting immunomodulatory treatment or prior treatment (at any time) with total lymphoid irradiation or bone marrow transplantation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of >=1 point compared with baseline in adjusted INCAT (aINCAT) score at week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| -Change from baseline in Inflammatory Rasch-Built Overall Disability Scale (I-RODS) centile points score -Change from baseline in Medical Research Council Sum Score (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 Timed Up and Go (TUG) -Time to increase of >=1 point compared with baseline in aINCAT score up to week 24 -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 score over time -Change from baseline in EQ-5D-5L over time -Change from baseline in Rasch-transformed Fatigue Severity Scale (RT-FSS) over time -Change from baseline in Brief Pain Inventory-Short Form (BPI-SF) over time -Patient Global Impression of Severity (PGI-S) values over time -Patient Global Impression of Change (PGI-C) values over time -Incidence of antidrug antibody(ies) (ADA) against empasiprubart in serum -Incidence of neutralizing antibody(ies) (Nab) against empasiprubart in serum -Incidence of AEs and SAEs -Percentage change from baseline in free C2 and total C2 over time -Serum concentrations of empasiprubart over time -Reduction of >=1 point in aINCAT over time -Increase of >=1 point from baseline in aINCAT 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