Phase 3 Peripheral Neuropathy Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with CIDP (Chronic Inflammatory Demyelinating Polyneuropathy) or possible CIDP, specifically the typical form, the mainly motor form, or the multifocal form (also called Lewis Sumner Syndrome), confirmed by a study review committee
• People who have responded to IVIg treatment (an infusion-based immune therapy) at some point in the past 5 years
• People who are currently on a regular, stable dose of IVIg as a maintenance treatment, following standard treatment guidelines
• People who still have some remaining disability from CIDP, measured by a specific scoring scale (INCAT score between 2 and 9) at the time of screening and confirmed again at the start of the study
• People whose CIDP is considered active, based on a disease activity score of 2 or more at screening
• People who have received vaccinations against certain bacterial infections within the past 5 years, or who are able to begin those vaccinations at least 14 days before the first study dose
• People who have experienced at least one clear worsening of their CIDP within the past 2 years, or at least two clear worsenings within the past 5 years, that happened when their IVIg treatment was paused, reduced, or spaced out — supported by clinical records or examination
• People whose body weight at screening is between 35 kg and 154 kg (approximately 77 to 340 lbs)
• People who are not pregnant, not breastfeeding, and who agree to use appropriate contraception if sexually active; male participants must also agree not to donate sperm during the study
• People who receive IVIg at home may be considered, provided their infusions are moved to a hospital or clinic setting at least one full treatment cycle before the study baseline visit

Who may not be able to join:

• People whose nerve condition is caused by something other than CIDP, such as Guillain-Barré syndrome, inherited nerve disorders, nerve damage from infection or other diseases, diabetic nerve damage, nerve damage from drugs or toxins, multifocal motor neuropathy, nerve problems related to certain blood protein abnormalities (IgM monoclonal gammopathy or POEMS syndrome), or nerve problems in the lower back and hip area
• People who have the sensory-only, distal, or focal variants of CIDP
• People who have another neurological or systemic illness that could interfere with the study's assessments or treatments
• People with poorly controlled diabetes
• People who had a serious infection requiring hospital admission within 30 days before screening, who have an active infection during screening, or who have a medical history that puts them at higher risk of infection (such as a known immune deficiency or a history of frequent infections)
• People who have been diagnosed with Systemic Lupus Erythematosus (SLE, a type of autoimmune disease), or who have a family history of SLE; people with certain blood test results suggesting possible SLE must have that diagnosis ruled out before joining
• People who have had an allergic reaction to the study drug (riliprubart) or its components, or who have had a severe allergic or anaphylactic reaction to any similar type of medicine (humanised or murine monoclonal antibodies), or who have allergies to any other study components that the investigator considers would make participation unsafe
• People who have medical reasons that prevent the safe use of immunoglobulin therapy, such as a history of serious allergic reactions to it, chronic kidney disease, blood clot disorders, or a known IgA deficiency
• People with any other significant ongoing medical condition that the investigator believes could affect safety, data quality, or the balance of risks and benefits in this trial
• People who have attempted suicide in the 6 months before screening, who are experiencing serious suicidal thoughts (category 4 or 5 on a standard assessment scale) during screening, or who the investigator believes may be at risk of a suicide attempt
• People whose CIDP clearly worsened within 6 weeks after a previous vaccination in a way that the investigator considers was a relapse
• People who have recently had, or are planning to have, major surgery that could affect the trial results or put them at undue risk
• People who have recently received plasma exchange treatment (a procedure that filters the blood)
• People who have been treated within the past 3 months with immune-suppressing or immune-modifying medications, or with corticosteroid medicines above a low maintenance dose; or who have ever received certain powerful immune-suppressing or chemotherapy medicines with long-lasting effects (such as mitoxantrone, alemtuzumab, or cladribine)
• People who have previously received the study drug riliprubart
• People who have recently used any medicine that specifically blocks the complement system (a part of the immune system), such as eculizumab
• People who have ever had total lymphoid irradiation (a type of radiation treatment) or a bone marrow transplant
• People who have been treated with B-cell depleting medicines such as rituximab within the past 6 months
• People who have received any vaccination within 28 days before the first study dose (with some possible exceptions to be confirmed at screening)
• People who are currently participating in another clinical trial or who have received an experimental treatment within 12 weeks before screening (or longer, depending on the medicine involved)
• People whose screening blood test results or heart trace (ECG) are outside normal ranges in a way the investigator considers clinically significant for this trial
• People who test positive at screening for hepatitis B surface antigen, certain hepatitis B core antibodies (unless other test results indicate natural immunity), hepatitis C antibodies (unless a follow-up test confirms the infection has fully resolved), or HIV
• People who are pregnant (confirmed by a pregnancy test) or currently breastfeeding
• People who are in an institution by legal or regulatory order, or who are imprisoned
• People whom the investigator considers unsuitable for any reason, including medical conditions or concerns about their ability to follow study procedures
• People who are employees of the clinical study site or who are directly involved in running this study, or their immediate family members
• People for whom local country regulations would prevent participation in the study as defined by the trial protocol
• People who have recently received efgartigimod (another immune-related treatment)

Important: Always verify eligibility with the trial site directly before applying.