Phase 3 Peripheral Neuropathy Trial, Recruiting

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

Who might be able to join this trial:

• Adults aged 18 or older, of any gender.
• People who are willing and able to give written consent to participate and allow access to their personal health information.
• People who have a confirmed diagnosis of CIDP (Chronic Inflammatory Demyelinating Polyneuropathy) that meets specific 2021 international diagnostic guidelines.
• People whose CIDP causes a significant level of disability, measured on a standard disability scale (INCAT score between 2 and 9), where a score of 2 must come only from leg-related problems.
• People who are currently relying on immunoglobulin therapy, steroids, or other standard CIDP treatments to manage their condition.
• People who have weakness in at least two limbs.
• People whose condition has been clinically stable for the 12 weeks before the screening date — meaning no significant worsening of disability, no major changes in symptoms, and no significant changes to their treatment doses.

Who may not be able to join:

• People who are unable to give informed consent.
• People with a purely sensory form of CIDP or certain other variants of CIDP.
• People who are pregnant, breastfeeding, planning to become pregnant during the study, or unwilling to use effective contraception throughout the study (confirm with trial site for specific requirements).
• People who require high doses of intravenous immunoglobulin (more than 1.4 g/kg/month) or subcutaneous immunoglobulin (more than 1.6 g/kg/month).
• People who have previously tried immunoglobulin therapy and it did not work for them.
• People with a body mass index (BMI) over 35, or for whom the immunoglobulin dose required would put them at risk of fluid overload.
• People whose nerve condition is caused by something other than CIDP, such as an inherited nerve disease (for example, Charcot-Marie-Tooth disease), an infection (such as Lyme disease), lupus, certain cancers or blood disorders, diabetes-related nerve damage, or other specific conditions listed in the trial criteria.
• People with a specific type of abnormal protein in their blood called IgM paraproteinemia, including a related condition involving antibodies to a nerve protein (myelin-associated glycoprotein).
• People with certain brain or spinal cord conditions involving loss of protective nerve coating (such as multiple sclerosis), or severe muscle disease.
• People with any long-term or serious condition affecting the nervous system or physical function that could interfere with assessing CIDP — such as severe arthritis, stroke, or Parkinson's disease. People with well-controlled diabetes (HbA1c below 7.5% at screening, with a commitment to maintain good blood sugar control) may still be considered (confirm with trial site).
• People with serious heart conditions, including severe heart failure, unstable chest pain, unstable irregular heart rhythms, or uncontrolled high blood pressure (above specific thresholds — confirm with trial site).
• People who have had a blood clot in a vein or a clot-related event such as a stroke or pulmonary embolism in the past 12 months.
• People with conditions that affect how the body breaks down or uses proteins, such as protein-losing gut disorders or kidney conditions that cause protein loss in urine.
• People with a known history of chronic kidney disease, or reduced kidney function below a specific level at the time of screening.
• People with an active cancer requiring chemotherapy or radiation, or a history of cancer where full remission has been in place for less than 2 years before screening. Some skin cancers and certain other non-active cancers may be excepted (confirm with trial site).
• People who have had allergic or severe reactions to human blood products such as immunoglobulin (IgG), albumin, or similar products.
• People with a known history of IgA deficiency (a specific immune protein deficiency).
• People with a known history of certain immune-related nerve conditions caused by specific antibodies (such as anti-NF186, anti-NF155, anti-CNTN1, or anti-CASPR1) that cause resistance to immunoglobulin treatment.
• People with certain abnormal blood test results at screening, including elevated liver enzymes, low platelet count, low neutrophil count, or significant anaemia (confirm with trial site for specific thresholds).
• People with an active hepatitis B, hepatitis C, or HIV infection. People with chronic hepatitis B or C who are on treatment and have had an undetectable viral load within 12 months of screening may still be considered (confirm with trial site).
• People who have recently received certain treatments before the trial washout period, including plasma exchange, changes to certain immunosuppressant medications, specific drugs such as efgartigimod alfa (Vyvgart), cyclophosphamide, rituximab, alemtuzumab, or other immunosuppressive therapies — with different waiting periods required depending on the specific treatment (confirm with trial site for timing details).
• People who have previously had a stem cell transplant using blood-forming cells.
• People still on corticosteroids specifically for treating CIDP after completing the washout period. People on low-dose steroids for unrelated conditions may be considered in some circumstances (confirm with trial site).
• People with any other condition or situation that the trial doctor believes could make participation unsafe or affect the reliability of the results.
• People who have participated in another clinical trial involving an experimental treatment within 30 days before screening, or within 5 half-lives of that experimental treatment, or who plan to join another such trial during this study.
• People with inherited or acquired blood-clotting disorders that increase the risk of blood clots — including conditions such as Factor V Leiden mutation, antiphospholipid antibody syndrome, protein C or S deficiency, and others listed in the trial criteria.
• People who have previously taken part in this specific trial (with a limited exception for those who withdrew only during the washout phase, before being randomly assigned to a treatment group).
• People who, for any other reason the trial doctor identifies, would not be able to follow the trial's requirements.

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