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RECRUITING
NCT07540221
PHASE3

A Study to Evaluate the Pharmacokinetics and Safety of XEMBIFY Versus Gamunex-C in Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Sponsor: Grifols Therapeutics LLC

View on ClinicalTrials.gov

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.

Official title: An Open-Label, Multicenter Study to Evaluate the Pharmacokinetics and Safety of XEMBIFY Versus Gamunex-C in Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-04-02

Completion Date

2027-12-31

Last Updated

2026-06-24

Healthy Volunteers

No

Interventions

BIOLOGICAL

Gamunex-C

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

BIOLOGICAL

Xembify

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

Locations (6)

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 110

New York, New York, United States

GC2402 Study Site 111

Cordova, Tennessee, United States

GC2402 Study Site 106

Sherman, Texas, United States