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 signed a written consent form before any study activities begin.
• People who weigh between 40 kg and 120 kg.
• People with a confirmed or possible diagnosis of CIDP (a nerve condition), including typical CIDP or certain variants (motor or multifocal CIDP), as confirmed by an independent review panel.
• People whose CIDP disease activity scores meet a required threshold at the screening stage (confirm with trial site).
• People whose condition is considered neurologically stable.
• People whose disability score (called the INCAT score) falls between 2 and 9 (confirm with trial site).
• People who fall into one of these treatment situations: currently being treated with immunoglobulin therapy (given by vein or under the skin), with or without steroid tablets, and have responded to it; or previously responded to such treatment but no longer receive it; or currently responding to steroid tablets alone or combined with certain other medicines; or have tried immunoglobulin and/or steroids but the treatment did not work well enough, was not tolerated, or was medically not suitable; or have never received any treatment for CIDP.
• People who have received vaccinations against certain types of bacteria, as required by local guidelines and based on vaccine availability.
• Female participants who are not able to become pregnant, or who agree not to try to become pregnant, not to donate eggs, and to use a highly effective form of contraception if sexually active with a male partner.
• Male participants who agree not to donate sperm and to use an acceptable form of contraception if sexually active with a female partner who could become pregnant, or who have been surgically sterilised for at least 90 days before the screening visit.

Who may not be able to join:

• People who show signs or symptoms suggesting their nerve condition may be caused by something other than CIDP.
• People with known damage or disease affecting the central nervous system (brain or spinal cord).
• People with a significant medical or surgical condition, including any current illness or recent major surgery, that could affect safety or the study results.
• People with any other medical or mental health condition, or prior treatment history, that would make participation unsuitable.
• People with a known deficiency in a part of the immune system called complement, or who have tested positive for certain related antibodies.
• People diagnosed with lupus (SLE), or who have a parent, sibling, or child with lupus.
• People with an autoimmune disease affecting their joints, muscles, or nervous system.
• People with another condition that might affect how results are measured, such as severe diabetic nerve damage, fibromyalgia, or inflammatory or degenerative joint disease affecting the hands and feet.
• People with a past history of a specific bacterial infection called Neisseria meningitidis.
• People who have had an active cancer diagnosis in the five years before screening, with some exceptions including certain treated or low-risk skin cancers, treated cervical changes, or low-grade prostate cancer managed by observation only.
• People who test positive for HIV, hepatitis B, or hepatitis C.

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