chronic inflammatory demyelinating polyneuropathy
Conditions
Interventions
Treatment group:On Day 1 of the treatment period, an intravenous infusion of Ripertamab at a dose of 375 mg/m2 body surface area will be administered.
Control group:On Day 1 of the treatment period, an intravenous infusion of Placebo at a dose of 375 mg/m2 body surface area will be administered.
Sponsors
Second Affiliated Hospital of Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Ability to understand the trial requirements, provide written informed consent (including consent for the use and disclosure of research-related health information), and willingness and ability to comply with the trial protocol procedures (including required trial visits). (2) Age 18 years or older at the time of signing the informed consent form. (3) Diagnosis of definite chronic inflammatory demyelinating polyneuropathy (CIDP) according to the 2021 European Academy of Neurology/Peripheral Nerve Society (EAN/PNS) criteria. (4) CIDP Disease Activity Status (CDAS) score >= 2 at screening. (5) Inflammatory Neuropathy Cause and Treatment (INCAT) overall disability score of at least 2 at the first screening (where the 2 points are derived solely from lower limb disability). (6) Meeting any of the following conditions: Patients who, despite currently receiving oral corticosteroids (equivalent to prednisone =10 mg/day) and/or intravenous immunoglobulin (IVIg) or subcutaneous immunoglobulin (SCIg) and/or high-dose steroids, are willing to discontinue such treatment 1 month prior to screening; OR Treatment-naïve patients. (7) Negative pregnancy test at screening and negative urine pregnancy test up to baseline for female participants of childbearing potential. (8) Female participants of childbearing potential must use highly effective contraception methods (with a failure rate of <1% per year) from screening until 90 days after the last dose of the investigational medicinal product (IMP). (9) Non-sterilized male participants with female partners of childbearing potential must use a condom, and their partners must use highly effective contraception methods from screening until 90 days after the last dose of the IMP (with a failure rate of <1% per year). Male participants practicing true abstinence (when this is in line with the participant's preferred and usual lifestyle) are acceptable. Vasectomized male participants with documented post-vasectomy absence of sperm are eligible for inclusion. Furthermore, male participants are not allowed to donate sperm from screening until 90 days after the last dose of the IMP.
Exclusion criteria
Exclusion criteria: (1) Pure sensory atypical CIDP (as defined by EFNS/PNS); (2) Polyneuropathy due to other causes, including but not limited to: multifocal motor neuropathy (MMN), monoclonal gammopathy of undetermined significance (MGUS) with anti-myelin associated glycoprotein (MAG) IgM antibody, hereditary demyelinating neuropathy, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), lumbosacral radiculoplexus neuropathy, polyneuropathy most likely caused by diabetes mellitus, polyneuropathy most likely caused by systemic disease, polyneuropathy caused by medication or toxins; (3) Any other disease that could better explain the patient's symptoms and signs; (4) History of any myelopathy or evidence of central demyelination; (5) Current or prior (within 12 months prior to screening) history of alcohol, drug, or medication abuse; (6) Severe psychiatric disease (e.g., major depressive disorder, psychosis, bipolar disorder), history of suicide attempt, or current suicidal ideation, which in the opinion of the investigator, may pose an undue risk to the patient or affect the patient's ability to comply with the trial protocol; (7) Clinically significant active or chronic uncontrolled bacterial, viral, or fungal infection at screening, including patients with evidence of active viral infection at screening: Active Hepatitis B Virus (indicated by serological test results suggestive of active (acute or chronic) infection), Active Hepatitis C Virus (HCV): positive HCV-Ab serology, positive human immunodeficiency virus (HIV) serology associated with AIDS-defining conditions or with a CD4 count 10 mg/day (prednisone equivalent); (10) Pregnant and lactating females, and those intending to become pregnant during the trial or within 90 days after the last dose; (11) Presence of any other known autoimmune disease that, in the opinion of the investigator, may interfere with the accurate assessment of the clinical manifestations of CIDP; (12) Patients who have received live attenuated vaccines within 28 days prior to screening (patients who have received inactivated, subunit, polysaccharide, or conjugate vaccines at any time prior to screening are not considered an exclusion criterion); (13) History of malignancy, unless considered cured with adequate treatment >=3 years prior to the first dose and with no evidence of recurrence. Patients with the following cancers can be enrolled at any time: adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, carcinoma in situ of the breast, or prostate cancer (TNM stage T1a or T1b); (14) Patients previously enrolled in a repertoire trial and having received >=1 dose of repertoire; (15) History of known allergy to any component of repertoire; (16) Clinical e
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Risk of recurrence; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical improvement;Disease progression;Functional improvement;The proportion receiving salvage therapy;Total hospitalization duration;Duration of mechanical ventilation;Proportion of patients admitted to the ICU;Total duration of ICU admission;Change in adjusted Inflammatory Neuropathy Cause and Treatment Score from baseline;Change in Inflammatory Rasch-built Overall Disability Scale score from baseline;Change in Medical Research Council Score from baseline;Change in mean grip strength from baseline;Change in Timed Up and Go Test from baseline;Change in EuroQol Five Dimensions Five-Level Questionnaire from baseline;Change in serum total IgG levels from baseline;Changes in T-cell, B-cell, and their subset counts from baseline;Incidence of adverse events; | — |
Countries
China
Contacts
Public ContactQingwu Yang
Second Affiliated Hospital of Army Medical University
Outcome results
None listed