RecruitingPhase 3NCT07540221

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


Sponsor

Grifols Therapeutics LLC

Enrollment

40 participants

Start Date

Apr 2, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Gamunex-C and a biological treatment called Xembify for people with cidp (chronic inflammatory demyelinating polyradiculoneuropathy). The study is currently recruiting participants at 7 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALGamunex-C

Immune Globulin Injection (Human), 10% Caprylate/Chromatography Purified (IGIV-C 10%)

BIOLOGICALXembify

Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (IGSC 20%)


Locations(10)

GC2402 Study Site 104

Rancho Mirage, California, United States

GC2402 Study Site 109

Coral Springs, Florida, United States

GC2402 Study Site 105

Miami, Florida, United States

GC2402 Study Site 103

Port Charlotte, Florida, United States

GC2402 Study Site 110

New York, New York, United States

GC2402 Study Site 111

Cordova, Tennessee, United States

GC2402 Study Site 106

Sherman, Texas, United States

GC2402 Study Site 401

Hradec Králové, Czechia

GC2402 Study Site 206

Bydgoszcz, Poland

GC2402 Study Site 203

Katowice, Poland

View Full Details on ClinicalTrials.gov

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NCT07540221


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