Actively Recruiting
A Study to Evaluate the Pharmacokinetics and Safety of XEMBIFY Versus Gamunex-C in Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Led by Grifols Therapeutics LLC · Updated on 2026-04-20
40
Participants Needed
2
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. 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.
CONDITIONS
Official Title
A Study to Evaluate the Pharmacokinetics and Safety of XEMBIFY Versus Gamunex-C in Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have typical CIDP or a CIDP variant according to the 2021 criteria by the European Academy of Neurology/Peripheral Nerve Society (EAN/PNS), with CIDP or possible CIDP diagnosis.
- Weigh 90 kg or less and require an intravenous immunoglobulin (IGIV) dose between 0.3 to 1.0 g/kg every three weeks, totaling 20 to 90 g per dose.
- Clinically stable on IGIV treatment, with no recent changes or CIDP relapses requiring treatment within 12 weeks before screening and baseline visit.
You will not qualify if you...
- Diagnosis of polyneuropathy caused by other conditions, including multifocal motor neuropathy, hereditary demyelinating neuropathy, diabetic polyneuropathy, or drug/toxin-induced polyneuropathy.
- Severe diseases interfering with study evaluation, such as current cancer, history of bone marrow/stem cell transplant, advanced heart disease, severe kidney disease, secondary immune deficiency conditions, bleeding disorders, severe skin disease at injection sites, or substance abuse.
- History of blood clots or thrombotic episodes.
- Known severe allergic reactions or intolerability to blood products or previous intravenous immunoglobulin treatments.
- CIDP relapse requiring treatment changes within 12 weeks before screening or baseline.
- Recent treatment with certain immunosuppressants, biologics, plasma exchange, or high-dose corticosteroids.
- IGIV dose requirements outside the specified range (less than 0.3 g/kg or more than 1.0 g/kg every three weeks, or less than 20 g or more than 90 g per dose).
- Known IgA deficiency with antibodies against IgA.
- Significant kidney problems or severe liver enzyme elevations.
- Hemoglobin levels below 10 g/dL at screening.
- Current use of anticoagulation therapy making subcutaneous immunoglobulin administration unsafe.
- Known hyperviscosity syndrome.
- Known HIV, chronic hepatitis B, or chronic hepatitis C infections.
- Participation in another clinical trial involving investigational products within 30 days or 5 half-lives prior to screening.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
GC2402 Study Site 109
Coral Springs, Florida, United States, 33155
Actively Recruiting
2
GC2402 Study Site 105
Miami, Florida, United States, 33067
Actively Recruiting
Research Team
S
Sarah Duggan
CONTACT
O
Olga Titova
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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