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Compares treatment options for CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy)
Official title A Study to Evaluate the Pharmacokinetics and Safety of XEMBIFY Versus Gamunex-C in Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
ClinicalTrials.gov ID: NCT07540221
What this study is testing
What is Gamunex-C?
Gamunex-C is an investigational medicine, given as an once-weekly injectable medicine, being studied as a potential treatment for cidp (chronic inflammatory demyelinating polyradiculoneuropathy).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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. Participants with CIDP will first have up to 28 days of screening to make sure they can join the study.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Have typical CIDP or a CIDP variant according to the 2021 criteria established by the European Academy of Neurology/Peripheral Nerve Society...
- Participants ≤ 90 kg in body weight and requiring an IGIV dose equivalent to 0.3-1.0 g/kg every three weeks (Q3W) inclusive and between 20-90 g of...
- Clinically stable on IGIV, defined as no recent change in CIDP treatment or experienced a CIDP relapse requiring treatment, within 12 weeks prior to...
You likely can't join if
- Diagnosis of polyneuropathy of any other cause (including multifocal motor neuropathy; monoclonal gammopathy of uncertain significance with...
- Severe diseases and conditions that are likely to interfere with evaluation of the study product or satisfactory conduct of the study such as the...
- current malignancy or history of allogeneic bone marrow/stem cell transplant,
- cardiac insufficiency (New York Heart Association classes III/IV), cardiomyopathy, significant cardiac arrhythmia requiring treatment, unstable or...
- chronic kidney disease stage IV or V
- an acquired medical condition that is known to cause secondary immune deficiency, such as chronic lymphocytic leukemia, lymphoma, multiple myeloma...
See the full eligibility criteria
- Have typical CIDP or a CIDP variant according to the 2021 criteria established by the European Academy of Neurology/Peripheral Nerve Society (EAN/PNS). The level of diagnostic certainty may be CIDP or possible CIDP.
- Participants ≤ 90 kg in body weight and requiring an IGIV dose equivalent to 0.3-1.0 g/kg every three weeks (Q3W) inclusive and between 20-90 g of IGIV Q3W inclusive.
- 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.
- 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...
- 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:
- current malignancy or history of allogeneic bone marrow/stem cell transplant,
- cardiac insufficiency (New York Heart Association classes III/IV), cardiomyopathy, significant cardiac arrhythmia requiring treatment, unstable or advanced ischemic heart disease, congestive heart failure or severe...
- chronic kidney disease stage IV or V
- 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...
- known bleeding disorders
- severe skin disease at the planned injection sites
- alcohol, drug or medication abuse, or
- other disorders where IGSC therapy would be contraindicated during the study.
- History of a thrombotic episode (including deep vein thrombosis, known hypercoagulable state, myocardial infarction, pulmonary embolism, or thromboembolic stroke)
- Known allergic or other severe adverse reactions to blood products including intolerability to previous IVIG up to 1 g/kg Q3W, history of hemolysis after IVIG infusion, aseptic meningitis, recurrent severe headache...
- Has had a CIDP relapse requiring treatment modification within 12 weeks prior to Screening or between Screening and baseline visit
- Treatment with any of the following:
- alemtuzumab or rituximab within 12 months of Screening.
- cyclophosphamide, interferon, tumor necrosis factor-alpha inhibitors, fingolimod, or fragment crystallizable receptor (FCRn) blockers, within six months of Screening
- plasma exchange or complement inhibitors within three months of Screening.
- changes to the following treatment within three months of Screening: methotrexate, azathioprine, or mycophenolate or any other immunosuppressants within six months of Screening
- participants on corticosteroids ≥ 20 mg/day prednisone equivalent. Participants on low dose corticosteroids (\< 20 mg/day prednisone equivalent) may be enrolled if dose has been stable over the last three months prior...
- Participants requiring an IGIV dose equivalent to:
- greater than 1.0 g/kg every three weeks (Q3W) or
- less than 0.3 g/kg Q3W or
- greater than 90 g of IGIV Q3W or
- less than 20 g of IGIV Q3W.
- Known IgA deficient patients with known antibodies against IgA
- Known significant proteinuria (≥ 3+ or known urinary protein loss \>1 g/24 hours or nephrotic syndrome), acute renal failure, are on dialysis, and/or have severe renal impairment on Screening laboratory testing (blood...
- 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.
- Hemoglobin levels \< 10 g/dL at Screening.
- 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...
- Known hyperviscosity syndrome.
- Known HIV, chronic hepatitis B virus (HBV), or chronic hepatitis C virus (HCV) infection.
- Participation in another clinical trial within 30 days or if known, 5 half-lives of the treatment product prior to Screening (observational studies without investigative treatments [non-treatment] are permitted).
The study team makes the final eligibility decision.
Where it's taking place
- Rancho Mirage, California, United States
- Coral Springs, Florida, United States
- Miami, Florida, United States
- Port Charlotte, Florida, United States
- New York, New York, United States
- Cordova, Tennessee, United States
- Sherman, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rancho Mirage, California, United States; Coral Springs, Florida, United States; Miami, Florida, United States; Port Charlotte, Florida, United States; New York, New York, United States; Cordova, Tennessee, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.