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 diagnosed with typical CIDP or a CIDP variant (including "possible CIDP") based on the 2021 European Academy of Neurology/Peripheral Nerve Society guidelines.
• People who weigh 90 kg or less and whose current intravenous immunoglobulin (IVIG) treatment dose falls within a specific range — between 0.3 and 1.0 g per kg of body weight, and between 20 and 90 grams total, given every three weeks.
• People whose CIDP has been stable on IVIG treatment for at least 12 weeks before the screening visit, with no recent changes to their CIDP treatment and no recent CIDP flare-up requiring treatment during that time.

Who may not be able to join:

• People whose nerve condition is caused by something other than CIDP, including conditions such as multifocal motor neuropathy, certain inherited nerve diseases, nerve damage related to diabetes, or nerve damage caused by medications or toxins (confirm with trial site for the full list).
• People with certain serious health conditions, including active cancer, a history of bone marrow or stem cell transplant, significant heart problems, advanced kidney disease (stage IV or V), certain immune system disorders (such as lymphoma, multiple myeloma, or HIV/AIDS), bleeding disorders, severe skin disease at the planned injection sites, or substance misuse issues.
• People with a history of serious blood clots, including deep vein thrombosis, heart attack, pulmonary embolism, or stroke caused by a clot, or a known condition that increases the risk of clotting.
• People who have had a severe allergic or adverse reaction to blood products, including past reactions to IVIG such as haemolysis (breakdown of red blood cells), aseptic meningitis, recurring severe headaches, or severe skin reactions.
• People who have had a CIDP flare-up requiring a change in treatment within 12 weeks before the screening visit, or between the screening and baseline visits.
• People who have recently received certain medications, including alemtuzumab or rituximab within the past 12 months; cyclophosphamide, interferon, TNF-alpha inhibitors, fingolimod, or FcRn blockers within the past 6 months; plasma exchange or complement inhibitors within the past 3 months; or certain other immunosuppressant drugs within the past 3 to 6 months (confirm timeframes with trial site).
• People taking corticosteroids at a dose of 20 mg per day or more (prednisone equivalent); people on lower doses may be considered if the dose has been stable for at least 3 months and is not expected to change during the trial.
• People whose required IVIG dose falls outside the specified range — either too high (above 1.0 g/kg or above 90 g every three weeks) or too low (below 0.3 g/kg or below 20 g every three weeks).
• People with a known IgA deficiency who also have antibodies against IgA.
• People with significant protein in their urine, acute kidney failure, or severe kidney impairment identified through screening blood tests.
• People whose liver enzyme levels (AST or ALT) are more than 2.5 times the upper limit of normal on screening blood tests.
• People whose haemoglobin (a measure of red blood cells) is below 10 g/dL at screening.
• People currently taking blood-thinning medications (anticoagulants) that the investigator considers would make the study's subcutaneous injections inadvisable (confirm with trial site).
• People with a known condition called hyperviscosity syndrome (abnormally thick blood).
• People with known HIV, chronic hepatitis B, or chronic hepatitis C infection.
• People who have taken part in another clinical trial within 30 days before screening (or within 5 half-lives of the trial product, if known); observational studies without an investigational treatment are generally permitted.

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