Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
About this trial
This is an interventional treatment trial for Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Eligibility Criteria
Inclusion Criteria:
- Adults greater than or equal to (>=) 18 years of age at the time of consent and as applicable, must also meet the legal age of consent in the jurisdiction in which the study is taking place
- Diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) according to criteria of the European Academy of Neurology/Peripheral Nerve Society (EAN/PNS) 2021, progressing or relapsing forms. CIDP diagnosis to be adjudicated by independent committee during screening period
- Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score between 2 and 9 (a score of 2 has to be exclusively from leg disability)
- Fulfilling any of the following treatment conditions: a) Currently treated with pulsed corticosteroids, oral corticosteroids and/or intravenous immunoglobulin (IVIg) or subcutaneous immunoglobulin (SCIg) and the participant is willing to discontinue or taper this treatment at the first run-in visit; or b) Without previous treatment (treatment naive); or treatment with corticosteroids and/or IVIg or SCIg discontinued at least 3 months prior to screening (untreated)
- Active disease as determined by CIDP Disease Activity Status (CDAS) score >= 3
- Other protocol-defined inclusion criteria will apply
Exclusion Criteria:
- Has a history of severe and/or uncontrolled hepatic (example, viral/alcoholic/autoimmune hepatitis/cirrhosis and/or metabolic liver disease), gastrointestinal, renal, pulmonary, cardiovascular, psychiatric, neurological or musculoskeletal disorder, hypertension and/or any other medical or uncontrolled autoimmune disorder(s) (example, diabetes mellitus) or clinically significant abnormalities in screening laboratory that, might interfere with the participants full participation in the study, or might jeopardize the safety of the participant or the validity of the study results
- Pure sensory CIDP or chronic immune sensory polyradiculopathy (CISP) (EAN/PNS definition)
- Any other disease that could better explain the participant's signs and symptoms, such as significant persisting neurological deficits from stroke or central nervous system (CNS) trauma or peripheral neuropathy from another cause such as connective tissue disease or systemic lupus erythematosus
- Polyneuropathy of other causes, including the following: Multifocal motor neuropathy (MMN); Monoclonal gammopathy of uncertain significance with antimyelin associated glycoprotein (anti-MAG) immunoglobulin M (IgM) antibodies; Hereditary motor neuropathy; Hereditary neuropathy with liability to pressure palsies (HNPP); Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin change syndromes; Lumbosacral radiculoplexus neuropathy; Polyneuropathy most likely due to diabetes mellitus; Polyneuropathy most likely due to systemic illnesses; Drug- or toxin-induced polyneuropathy Note: A concomitant polyneuropathy of other causes (example, a mild, stable diabetic polyneuropathy) is not necessarily exclusionary if chronic inflammatory demyelinating polyneuropathy (CIDP) is confirmed as the main diagnosis, as determined by the investigator and confirmed by the adjudication committee
- Has known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients
- Other protocol-defined exclusion criteria will apply
Sites / Locations
- Neurology Associates PARecruiting
- University of Kansas Medical CenterRecruiting
- The Neurological Institute of New YorkRecruiting
- South Shore Neurologic Associates - PatchogueRecruiting
- The Neurological Institute, PARecruiting
- Austin Neuromuscular CenterRecruiting
- Xuanwu Hospital, Capital Medical UniversityRecruiting
- The First Affiliated Hospital of NanChang UniversityRecruiting
- Xi 'an GaoXin HospitalRecruiting
- Fakultni nemocnice Hradec KraloveRecruiting
- Fakultni nemocnice OstravaRecruiting
- Pardubicka krajska nemocnice a.s.Recruiting
- Asahikawa Medical CenterRecruiting
- Tokyo Medical and Dental University HospitalRecruiting
- Chiba University HospitalRecruiting
- Seirei Hamamatsu General HospitalRecruiting
- Kobe City Medical Center General HospitalRecruiting
- Tokai University HospitalRecruiting
- Saitama Medical CenterRecruiting
- Kumamoto University HospitalRecruiting
- Nagoya University HospitalRecruiting
- Chubu Rosai HospitalRecruiting
- Kindai University HospitalRecruiting
- Dokkyo Medical University HospitalRecruiting
- Tenri HospitalRecruiting
- Toyama University HospitalRecruiting
- Yamaguchi University HospitalRecruiting
- Konkuk University Medical CenterRecruiting
- Samsung Medical CenterRecruiting
- Centrum MedyczneRecruiting
- Specjalistyczne Gabinety LekarskieRecruiting
- National Taiwan University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Nipocalimab
Placebo
Participants in Stage A (Open-label) will receive a loading dose of nipocalimab (Dose 1) intravenous (IV) infusion on Day 1, followed by nipocalimab (Dose 2) IV infusion once every 2 weeks (q2w) from Week 2 to Week 12. Participants who demonstrate evidence of clinical improvement in Stage A (responders) will enter Stage B (Double-blind) and receive nipocalimab (Dose 2) IV infusion q2w starting on Day 1 up to Week 52. After completion of Stage B or discontinuation from Stage B due to relapse, participants will have the option to enter the open label extension (OLE) phase and receive nipocalimab (Dose 2) IV infusion q2w starting on OLE Day 1 until 2 years after marketing authorization in a participant's local country or until nipocalimab becomes available commercially or via other continued access program, whichever comes first.
Participants receiving nipocalimab in Stage A and who demonstrate evidence of clinical improvement in Stage A (responders) will enter Stage B (Double-blind) and receive placebo IV infusion q2w starting on Day 1 up to Week 52. After completion of Stage B or discontinuation from Stage B due to relapse, participants will have the option to enter the open label extension (OLE) phase and receive nipocalimab (Dose 2) IV infusion q2w starting on OLE Day 1 until 2 years after marketing authorization in a participant's local country or until nipocalimab becomes available commercially or via other continued access program, whichever comes first.