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

NCT07540221 | Recruiting Phase 3 FDA Drug

• 1 other identifier: GC2402
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy)

Keywords

XEMBIFY; CIDP; IgG; Gamunex-C

Outcome Measures

Primary Outcomes (2)

• AUC in the IV Phase: Steady-state area under the concentration-time curve (AUC) of total IgG over a 3-week intravenous dosing interval (τ) (i.e., AUC(0-21days) in participants with CIDP

  Week 1 to 19 of IV Phase

• AUC in the SC Phase: Steady-state AUC of total IgG over a weekly SC dosing interval (τ) (i.e., AUC(0-7days)) in participants with CIDP

  Week 1 to 16 of SC Phase

Secondary Outcomes (1)

• Steady-state mean trough (pre-dose) concentration of total IgG following IV administration of Gamunex-C 10% every 3 weeks SC administration of Xembify 20% once weekly

  Day 1 through End of Study Visit (approximately 35 weeks)

Study Arms (2)

Gamunex-C (IGIV-C 10%)

EXPERIMENTAL

During the IV Phase, participants will receive Gamunex-C 1 g/kg, up to a maximum dose of 90 g, every 3 weeks for a total of seven doses. Gamunex-C may be administered over 1 day or divided into 2 consecutive daily doses of 0.5 g/kg each, except for dose #6, which will be administered as a single 1g/kg dose.

Biological: Gamunex-C

Xembify (IGSC 20%)

EXPERIMENTAL

Approximately 7 to 10 days after the last Gamunex-C dose, participants will enter a 16-week SC Phase, where they will receive XEMBIFY 0.456 g/kg once weekly for a total of 16 doses, up to a maximum dose of 41 g.

Biological: Xembify

Interventions

Xembify BIOLOGICAL

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

Xembify (IGSC 20%)

Gamunex-C BIOLOGICAL

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

Gamunex-C (IGIV-C 10%)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 neuropathy; polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes syndrome; lumbosacral radiculoplexus neuropathy; polyneuropathy associated with diabetes mellitus; polyneuropathy associated with systemic illnesses; or drug or toxin induced polyneuropathy).
• 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 hypertension
• 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 1000/µL \[1.0 × 10\^9/L\]), or human immunodeficiency virus (HIV) infection/acquired immune deficiency syndrome
• 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, hypersensitivity, or severe generalized skin reaction
• 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.

Sponsors & Collaborators

• Grifols Therapeutics LLC: lead

Study Sites (2)

GC2402 Study Site 109

Coral Springs, Florida, 33155, United States

RECRUITING

GC2402 Study Site 105

Miami, Florida, 33067, United States

RECRUITING

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Interventions

Hizentra

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sarah Duggan

CONTACT

+353 87 429 2411; sarah.duggan@grifols.com

Olga Titova

CONTACT

olga.titova@grifols.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 20, 2026
• Study Start: April 2, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)