Actively Recruiting
Study to Evaluate Pharmacokinetics and Safety of XEMBIFY Versus Gamunex-C in People With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Led by Grifols Therapeutics LLC · Updated on 2026-05-15
40
Participants Needed
5
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the pharmacokinetics and safety of two immune globulin treatments, XEMBIFY and Gamunex-C, in people with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP). The study aims to find out whether weekly under-the-skin doses of XEMBIFY provide similar levels of immunoglobulin G (IgG) in the blood over time compared to Gamunex-C, which is given intravenously every three weeks. This phase 3, open-label study involves participants who are clinically stable on intravenous immunoglobulin treatment and meet specific diagnostic criteria for CIDP. Participants will first undergo up to 28 days of screening to confirm eligibility. They will then receive Gamunex-C intravenously once every three weeks for 19 weeks, totaling seven doses. About one week after the last Gamunex-C dose, participants will begin 16 weekly doses of XEMBIFY administered under the skin over a 16-week period. The Gamunex-C doses may be given in one day or split over two consecutive days, with specific dosing details outlined for each infusion. Throughout both treatment periods, blood samples will be collected to measure IgG levels and monitor steady-state concentrations. The study will assess pharmacokinetic parameters such as the area under the concentration-time curve (AUC) during both intravenous and subcutaneous dosing intervals. Safety, tolerability, and treatment adherence will also be monitored. Total study participation spans approximately 35 weeks, including screening, treatment, and follow-up visits.
CONDITIONS
Brief 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 2021 criteria by European Academy of Neurology/Peripheral Nerve Society
- Weigh 90 kilograms or less
- Require an intravenous immunoglobulin dose of 0.3 to 1.0 g/kg every 3 weeks, between 20 and 90 grams total
- Clinically stable on intravenous immunoglobulin with no treatment changes or CIDP relapses in the last 12 weeks
- Adults aged 18 years or older
You will not qualify if you...
- Diagnosis of polyneuropathy from causes other than CIDP
- Current or history of severe diseases interfering with study evaluation, including malignancy, severe heart or kidney disease
- Acquired conditions causing immune deficiency such as leukemia, lymphoma, HIV/AIDS
- Known bleeding disorders or severe skin disease at injection sites
- Alcohol, drug, or medication abuse
- History of thrombotic episodes like deep vein thrombosis or stroke
- Known severe allergic reactions or intolerance to blood products or IVIG
- Recent CIDP relapse requiring treatment change within 12 weeks
- Recent or current use of certain immunosuppressants or biological therapies
- Immunoglobulin dosing needs outside of specified ranges
- Known IgA deficiency with antibodies against IgA
- Significant kidney impairment or abnormal liver enzyme levels
- Hemoglobin below 10 g/dL at screening
- Current use of anticoagulation therapy contraindicating subcutaneous immunoglobulin
- Known hyperviscosity syndrome
- Known HIV, chronic hepatitis B or C infection
- Participation in another clinical trial within 30 days prior to screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 19 weeks
Participants receive intravenous Gamunex-C every 3 weeks for a total of seven doses.
7 visits (in-person) every 3 weeks
Duration - 16 weeks
Participants receive subcutaneous XEMBIFY once weekly for a total of 16 doses.
16 weekly visits (in-person or at home)
Trial Site Locations
Total: 5 locations
1
GC2402 Study Site 104
Rancho Mirage, California, United States, 92270
Actively Recruiting
2
GC2402 Study Site 109
Coral Springs, Florida, United States, 33155
Actively Recruiting
3
GC2402 Study Site 105
Miami, Florida, United States, 33067
Actively Recruiting
4
GC2402 Study Site 110
New York, New York, United States, 10003
Actively Recruiting
5
GC2402 Study Site 106
Sherman, Texas, United States, 75092
Actively Recruiting
Research Team
S
Sarah Duggan
O
Olga Titova
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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