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:

• The person is willing and able to understand and follow all trial procedures and requirements, as judged by the trial investigator.
• The person has provided written, signed, and dated consent before any trial procedures begin.
• A neurologist specialising in neuromuscular diseases has confirmed a diagnosis of CIDP or possible CIDP, based on the EFNS/PNS 2021 criteria.
• The person has a documented history of responding to immunoglobulin (IgG) treatment, meaning their neurological symptoms partially or fully improved with that treatment.
• The person is currently on a stable course of a specific type of immunoglobulin therapy (given by drip into a vein, or by injection under the skin) at an approved dose and has been on this stable treatment for at least 12 weeks before the screening visit, with dosing given within specified time intervals.
• The person has a disability score (measured using a specific scale called the INCAT score) that falls within a defined range, with additional conditions around the pattern and history of that score (confirm with trial site for the exact scoring details).
• People who could become pregnant must have a negative pregnancy test at screening and must agree to use highly effective contraception throughout the trial and for at least 30 days after the last dose of the trial treatment.

Who may not be able to join:

• People who have been diagnosed with a focal, multifocal, distal, or sensory form of CIDP, or possible versions of these, based on the EFNS/PNS 2021 criteria.
• People whose nerve condition is caused by something other than CIDP, such as an inherited nerve disorder (for example, Charcot-Marie-Tooth disease), an infection (such as Lyme disease), another medical condition (such as lupus, lymphoma, or amyloidosis), a nerve condition affecting motor function only (multifocal motor neuropathy), or nerve damage caused by drugs, chemotherapy, or toxins.
• People who have another long-term or serious condition affecting the nervous system that could interfere with assessing CIDP, such as multiple sclerosis, Parkinson's disease, stroke, arthritis, or diabetic nerve damage. (Note: people with diabetes who do not have diabetic nerve damage and whose blood sugar is well controlled may still be considered — confirm with trial site.)
• People who have taken or currently need to take immune-suppressing or immune-modifying medications — other than the immunoglobulin therapies specified — within 6 months before screening. This includes medications such as rituximab, efgartigimod, complement inhibitors, or chemotherapy drugs.
• People who have taken high-dose steroid tablets (above a certain daily amount) for more than 30 days within the 3 months before screening. (Lower doses or short courses of steroids may be acceptable — confirm with trial site.)
• People who have had a plasma exchange treatment within 3 months before screening.
• People who have a specific protein abnormality in their blood called IgM paraproteinemia, including a related condition involving antibodies to nerve-coating proteins.
• People who have a specific immune deficiency (IgA deficiency) combined with known antibodies against IgA and a history of serious reactions to human immunoglobulin treatment.
• People who have conditions that affect how the body processes or uses proteins, such as protein-losing gut disease or nephrotic syndrome.
• People who have a history of significant kidney disease or whose kidney function is measured below a certain level at screening.
• People who have had a cancer diagnosis within the past 2 years without full remission, or who currently have active cancer requiring chemotherapy or radiation therapy. (Some skin cancers or stable prostate cancer not requiring treatment may be acceptable — confirm with trial site.)
• People who have serious heart conditions, including severe heart failure, unstable chest pain, unstable heart rhythm problems, or uncontrolled high blood pressure.
• People who have an inherited or acquired condition that increases the risk of blood clots, such as protein C deficiency, protein S deficiency, antithrombin deficiency, or antiphospholipid antibody syndrome.
• People who have had a serious blood clot — such as a deep vein thrombosis, stroke, or pulmonary embolism — within the 12 months before screening.
• People who have any other medical condition, abnormal test result, or finding that the investigator believes would make participation unsafe or interfere with completing the trial.
• People who have a known history of serious allergic reactions to immunoglobulin treatments given by vein or under the skin.
• People who have a known allergy to any ingredient in the trial treatment (TAK-881/HYQVIA), or to hyaluronidase or rHuPH20 (components used in the trial medication).
• People who currently have, or have tested positive for, hepatitis B, hepatitis C (by a specific viral detection test), or HIV. (People previously treated for hepatitis C who test negative at screening may be considered — confirm with trial site.)
• People who have significant anaemia that would make repeated blood tests unsafe, or whose haemoglobin level is below a certain level at screening.
• People whose blood tests at screening show liver enzyme levels above a specified threshold, a low platelet count, or a low level of a particular type of white blood cell.
• People who are pregnant or breastfeeding at the time of screening.
• People who have participated in another clinical trial involving an experimental treatment or device within 12 weeks (or longer, depending on the medication) before enrolling in this trial, or who plan to join another such trial during this one. (An exception may apply for participants rolling over from a specific related Japanese trial — confirm with trial site.)
• People who are employed by the trial site, or who are a close family member or dependent of a trial site employee involved in running this trial, or who may be in a situation where their consent could be given under pressure.

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