[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cidp-chronic-inflammatory-demyelinating-polyradiculoneuropathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cidp-chronic-inflammatory-demyelinating-polyradiculoneuropathy":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,73],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100634479","phase-3-a-study-to-evaluate-the-pharmacokinetics-and-safety-of-xembify-versus-gamunex-c-in-participants-with-chronic-inflammatory-demyelinating-polyradiculoneuropathy-100634479",false,"NCT07540221","A Study to Evaluate the Pharmacokinetics and Safety of XEMBIFY Versus Gamunex-C in Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy","An Open-Label, Multicenter Study to Evaluate the Pharmacokinetics and Safety of XEMBIFY Versus Gamunex-C in Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy","XPERT","Inclusion Criteria:\n\n* Have typical CIDP or a CIDP variant according to the 2021 criteria established by the European Academy of Neurology\u002FPeripheral Nerve Society (EAN\u002FPNS). The level of diagnostic certainty may be CIDP or possible CIDP.\n* Participants ≤ 90 kg in body weight and requiring an IGIV dose equivalent to 0.3-1.0 g\u002Fkg every three weeks (Q3W) inclusive and between 20-90 g of IGIV Q3W inclusive.\n* Clinically stable on IGIV, defined as no recent change in CIDP treatment or experienced a CIDP relapse requiring treatment, within 12 weeks prior to Screening and through baseline visit.\n\nExclusion Criteria:\n\n* Diagnosis of polyneuropathy of any other cause (including multifocal motor neuropathy; monoclonal gammopathy of uncertain significance with anti-myelin-associated glycoprotein IgM antibodies; hereditary demyelinating neuropathy; polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes syndrome; lumbosacral radiculoplexus neuropathy; polyneuropathy associated with diabetes mellitus; polyneuropathy associated with systemic illnesses; or drug or toxin induced polyneuropathy).\n* Severe diseases and conditions that are likely to interfere with evaluation of the study product or satisfactory conduct of the study such as the following:\n\n  1. current malignancy or history of allogeneic bone marrow\u002Fstem cell transplant,\n  2. cardiac insufficiency (New York Heart Association classes III\u002FIV), cardiomyopathy, significant cardiac arrhythmia requiring treatment, unstable or advanced ischemic heart disease, congestive heart failure or severe hypertension\n  3. chronic kidney disease stage IV or V\n  4. an acquired medical condition that is known to cause secondary immune deficiency, such as chronic lymphocytic leukemia, lymphoma, multiple myeloma, chronic or recurrent neutropenia (absolute neutrophil count less than 1000\u002FµL \\[1.0 × 10\\^9\u002FL\\]), or human immunodeficiency virus (HIV) infection\u002Facquired immune deficiency syndrome\n  5. known bleeding disorders\n  6. severe skin disease at the planned injection sites\n  7. alcohol, drug or medication abuse, or\n  8. other disorders where IGSC therapy would be contraindicated during the study.\n* History of a thrombotic episode (including deep vein thrombosis, known hypercoagulable state, myocardial infarction, pulmonary embolism, or thromboembolic stroke)\n* Known allergic or other severe adverse reactions to blood products including intolerability to previous IVIG up to 1 g\u002Fkg Q3W, history of hemolysis after IVIG infusion, aseptic meningitis, recurrent severe headache, hypersensitivity, or severe generalized skin reaction\n* Has had a CIDP relapse requiring treatment modification within 12 weeks prior to Screening or between Screening and baseline visit\n* Treatment with any of the following:\n\n  1. alemtuzumab or rituximab within 12 months of Screening.\n  2. cyclophosphamide, interferon, tumor necrosis factor-alpha inhibitors, fingolimod, or fragment crystallizable receptor (FCRn) blockers, within six months of Screening\n  3. plasma exchange or complement inhibitors within three months of Screening.\n  4. changes to the following treatment within three months of Screening: methotrexate, azathioprine, or mycophenolate or any other immunosuppressants within six months of Screening\n  5. participants on corticosteroids ≥ 20 mg\u002Fday prednisone equivalent. Participants on low dose corticosteroids (\\\u003C 20 mg\u002Fday prednisone equivalent) may be enrolled if dose has been stable over the last three months prior to Screening and the dosage is not likely to be adjusted during the duration of the trial (inhaled or topical corticosteroids are allowed).\n* Participants requiring an IGIV dose equivalent to:\n\n  1. greater than 1.0 g\u002Fkg every three weeks (Q3W) or\n  2. less than 0.3 g\u002Fkg Q3W or\n  3. greater than 90 g of IGIV Q3W or\n  4. less than 20 g of IGIV Q3W.\n* Known IgA deficient patients with known antibodies against IgA\n* Known significant proteinuria (≥ 3+ or known urinary protein loss \\>1 g\u002F24 hours or nephrotic syndrome), acute renal failure, are on dialysis, and\u002For have severe renal impairment on Screening laboratory testing (blood urea nitrogen \\[BUN\\] \\> 3 times the upper limit of normal \\[ULN\\] or creatinine more than 1.5 times ULN).\n* Screening values of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels exceeding ≥ 2.5 times the ULN for the expected normal range for the testing laboratory.\n* Hemoglobin levels \\\u003C 10 g\u002FdL at Screening.\n* Current administration of anti-coagulation therapy which would make IGSC administration inadvisable per investigator judgement (i.e., vitamin K antagonists, nonvitamin K antagonist oral anticoagulants \\[e.g., dabigatran etexilate targeting Factor IIa, rivaroxaban, edoxaban, and apixaban targeting Factor Xa\\], and parenteral anticoagulants \\[e.g., fondaparinux\\]).\n* Known hyperviscosity syndrome.\n* Known HIV, chronic hepatitis B virus (HBV), or chronic hepatitis C virus (HCV) infection.\n* Participation in another clinical trial within 30 days or if known, 5 half-lives of the interventional product prior to Screening (observational studies without investigative treatments \\[non-interventional\\] are permitted).","ALL","18 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The main goal of the study is to find out whether XEMBIFY, given once a week under the skin, provides similar levels of immunoglobulin G in the blood over time as Gamunex-C, which is given into a vein once every 3 weeks in people with CIDP.\n\nParticipants with CIDP will first have up to 28 days of screening to make sure they can join the study. Those who qualify will then start a 19-week treatment period with Gamunex-C. During this period, they will receive Gamunex-C through a vein once every 3 weeks, for a total of 7 doses. Approximately, one week after their last Gamunex-C dose, they will begin a 16-week treatment period with XEMBIFY under the skin, once a week for a total of 16 doses. Blood samples will be collected during both treatment periods to measure IgG level in the blood.",[27],"CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy)",[29,30,31,32],"XEMBIFY","CIDP","IgG","Gamunex-C","RECRUITING","2026-06-22",{"date":36,"type":37},"2026-06-24","ACTUAL",{"date":39,"type":37},"2026-04-02",{"date":41,"type":21},"2027-12-31",{"name":43,"class":44},"Grifols Therapeutics LLC","INDUSTRY",6,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":4},"100643609","phase-2-a-study-to-assess-the-correct-dose-safety-and-efficacy-of-empasiprubart-in-adolescent-participants-aged-12-to-less-than-18-years-with-chronic-inflammatory-demyelinating-polyradiculoneuropathy-100643609","NCT07638566","A Study to Assess the Correct Dose, Safety and Efficacy of Empasiprubart in Adolescent Participants Aged 12 to Less Than 18 Years With Chronic Inflammatory Demyelinating Polyradiculoneuropathy","An Open-Label Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Activity of Empasiprubart in Adolescent Participants Aged 12 to Less Than 18 Years With Chronic Inflammatory Demyelinating Polyradiculoneuropathy","emlight","Inclusion Criteria:\n\n* Is aged 12 to \\\u003C18 years.\n* Meets criteria for CIDP based on EAN\u002FPNS Task Force CIDP guidelines, second revision (2021).\n* Has a diagnosis of either typical CIDP or 1 of the following CIDP variants: motor CIDP (including motor-predominant CIDP), multifocal CIDP (also known as Lewis-Sumner syndrome), focal CIDP, or distal CIDP.\n\nExclusion Criteria:\n\n* Possible CIDP based on EAN\u002FPNS Task Force CIDP guidelines, second revision (2021).\n* Sensory CIDP (including sensory-predominant CIDP).\n* Besides the indication under study, known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of CIDP, or that puts the participant at undue risk.\n* Prior use of other long-acting immunomodulatory treatment.","12 Years","17 Years",{"count":45,"type":21},[58,24],"PHASE2","The main purpose of the study is to determine the correct dose of empasiprubart in adolescent participants. It also aims to evaluate if empasiprubart may work and how safe it is for the use in children living with CIDP.\n\nThe study consists of an open label treatment phase where participants will receive empasiprubart for up to 27 months approximately. After the final dose of empasiprubart, participants will enter a safety follow-up period for up to 14 months approximately.\n\nThe overall study duration for each participant is up to 43 months.\n\nMore information can be found here: clinicaltrials.argenx.com\u002Femlight",[61,27,30,62],"Chronic Inflammatory Demyelinating Polyradiculoneuropathy","Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)","NOT_YET_RECRUITING","2026-06-05",{"date":66,"type":37},"2026-06-10",{"date":68,"type":21},"2026-09",{"date":70,"type":21},"2031-08",{"name":72,"class":44},"argenx",{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":81,"phases":4,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},"100613272","real-world-efgartigimod-effectiveness-in-cidp-a-prospective-study-100613272","NCT07264426","Real-World Efgartigimod Effectiveness in CIDP: A Prospective Study","Inclusion Criteria:\n\n* Aged ≥18 years at time of providing informed consent\n* Diagnosed with CIDP\n* Planned to be receiving efgartigimod treatment within the CIDP treatment label of efgartigimod in the participant's respective country\n* Efgartigimod treatment-naïve at time of screening\n\nExclusion Criteria:\n\n* Polyradiculoneuropathy due to any other cause(s)\n* Current participation in any interventional clinical study at time of screening, or planned participation before initiation of efgartigimod",{"count":80,"type":21},200,"OBSERVATIONAL","The aims of this study are to assess the real-world effectiveness of efgartigimod in treating chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), describe the \"treatment journey\" of participants with CIDP, and assess the utilization of health care services among adult participants with CIDP who initiate treatment with efgartigimod.\n\nAs this is a noninterventional study, treatment choices and decisions will be left to the discretion of participants and their physicians, according to the standard of care.\n\nEach participant will be prospectively followed for up to 2 years from the date of initial administration of efgartigimod.",[61,30,27],"2026-04-22",{"date":86,"type":37},"2026-04-23",{"date":88,"type":37},"2025-08-11",{"date":90,"type":21},"2029-10",{"name":72,"class":44},23]