CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy)Phase 3XPERTNCT07540221
A Study to Evaluate the Pharmacokinetics and Safety of XEMBIFY Versus Gamunex-C in Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
A Phase 3 study testing Gamunex-C and Xembify in people with CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy), run by Grifols Therapeutics LLC at 15 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy)
- What is being tested?
- Gamunex-C and Xembify
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 15 sitesin 4 countries
- Study dates
- 2 Apr 2026to 31 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 32Show fewer
- 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.
- cyclophosphamide, interferon, tumor necrosis factor-alpha inhibitors, fingolimod, or fragment crystallizable receptor (FCRn) blockers, within six months of Screening
- plasma exchange or complement inhibitors within three months of Screening.
- changes to the following treatment within three months of Screening: methotrexate, azathioprine, or mycophenolate or any other immunosuppressants within six months of Screening
- participants on corticosteroids ≥ 20 mg/day prednisone equivalent. Participants on low dose corticosteroids (< 20 mg/day prednisone equivalent) may be enrolled if dose has been stable over the last three months prior to Screening and the dosage is not likely to be adjusted during the duration of the trial (inhaled or topical corticosteroids are allowed).
- Participants requiring an IGIV dose equivalent to:
- greater than 1.0 g/kg every three weeks (Q3W) or
- less than 0.3 g/kg Q3W or
- greater than 90 g of IGIV Q3W or
- less than 20 g of IGIV Q3W.
- Known IgA deficient patients with known antibodies against IgA
- Known significant proteinuria (≥ 3+ or known urinary protein loss >1 g/24 hours or nephrotic syndrome), acute renal failure, are on dialysis, and/or have severe renal impairment on Screening laboratory testing (blood urea nitrogen [BUN] > 3 times the upper limit of normal [ULN] or creatinine more than 1.5 times ULN).
- Screening values of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels exceeding ≥ 2.5 times the ULN for the expected normal range for the testing laboratory.
- Hemoglobin levels < 10 g/dL at Screening.
- Current administration of anti-coagulation therapy which would make IGSC administration inadvisable per investigator judgement (i.e., vitamin K antagonists, nonvitamin K antagonist oral anticoagulants [e.g., dabigatran etexilate targeting Factor IIa, rivaroxaban, edoxaban, and apixaban targeting Factor Xa], and parenteral anticoagulants [e.g., fondaparinux]).
- Known hyperviscosity syndrome.
- Known HIV, chronic hepatitis B virus (HBV), or chronic hepatitis C virus (HCV) infection.
- Participation in another clinical trial within 30 days or if known, 5 half-lives of the interventional product prior to Screening (observational studies without investigative treatments [non-interventional] are permitted).
Trial locations and contacts
15 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
Olga Titova contact
15 sites in 4 countries
United States9 sites, 8 recruiting
- Recruiting
GC2402 Study Site 109
Coral Springs, Florida, 33155
Sarah Duggan, sarah.duggan@grifols.com
- Recruiting
GC2402 Study Site 111
Cordova, Tennessee, 38018
Sarah Duggan, sarah.duggan@grifols.com
- Recruiting
GC2402 Study Site 114
Fayetteville, North Carolina, 28304
Sarah Duggan, sarah.duggan@grifols.com
- Recruiting
GC2402 Study Site 115
Houston, Texas, 77074
Sarah Duggan, sarah.duggan@grifols.com
- Withdrawn
GC2402 Study Site 105
Miami, Florida, 33067
- Recruiting
GC2402 Study Site 110
New York, New York, 10003
Sarah Duggan, sarah.duggan@grifols.com
- Recruiting
GC2402 Study Site 103
Port Charlotte, Florida, 33952
Sarah Duggan, sarah.duggan@grifols.com
- Recruiting
GC2402 Study Site 104
Rancho Mirage, California, 92270
Sarah Duggan, sarah.duggan@grifols.com
- Recruiting
GC2402 Study Site 106
Sherman, Texas, 75092
Sarah Duggan, sarah.duggan@grifols.com
Poland4 sites, 4 recruiting
- Recruiting
GC2402 Study Site 206
Bydgoszcz, 85-065
Sarah Duggan, sarah.duggan@grifols.com
- Recruiting
GC2402 Study Site 203
Katowice, 40-123
Sarah Duggan, sarah.duggan@grifols.com
- Recruiting
GC2402 Study Site 201
Krakow, 31-870
Sarah Duggan, sarah.duggan@grifols.com
- Recruiting
GC2402 Study Site 205
Wroclaw, 50-417
Sarah Duggan, sarah.duggan@grifols.com
Czechia1 site, 1 recruiting
- Recruiting
GC2402 Study Site 401
Hradec Králové, 50002
Sarah Duggan, sarah.duggan@grifols.com
Romania1 site, 1 recruiting
- Recruiting
GC2402 Study Site 302
Târgu Mureş, 540140
Sarah Duggan, sarah.duggan@grifols.com
About this study
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
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.
- Being tested
- Gamunex-C, Xembify
- Keywords
- XEMBIFY, CIDP, IgG, Gamunex-C
- Medical subject headings
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamunex-CBiological
Immune Globulin Injection (Human), 10% Caprylate/Chromatography Purified (IGIV-C 10%)
XembifyBiological
Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (IGSC 20%)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: Xembify |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Day 1 through End of Study Visit (approximately 35 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start2 Apr 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grifols Therapeutics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07540221
- Sponsor's protocol ID
- GC2402
- Acronym
- XPERT
- Status last verified
- Oct 2026
- First submitted
- 9 Apr 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07540221
- Acronym / sponsor ID
- XPERT / GC2402
- Keywords
- XEMBIFY, CIDP, IgG, Gamunex-C
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Grifols Therapeutics LLCIndustry (pharma, biotech, devices)
- Study start
- 2 Apr 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gamunex-C (IGIV-C 10%) | Experimental | Biological: Gamunex-CDuring 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. |
| Xembify (IGSC 20%) | Experimental | Biological: XembifyApproximately 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (32 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gamunex-CImmune Globulin Injection (Human), 10% Caprylate/Chromatography Purified (IGIV-C 10%) | Biological | Gamunex-C (IGIV-C 10%) |
| XembifyImmune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (IGSC 20%) | Biological | Xembify (IGSC 20%) |
Primary outcome
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
Time frame: 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
Time frame: Week 1 to 16 of SC Phase
1 secondary outcome
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
Time frame: Day 1 through End of Study Visit (approximately 35 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy)
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
RecruitingPhase 3
A Study Investigating Intravenous Human Normal Immune Globulin (IGIV) 10% KIg10 (QIVIGY) in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Chronic Inflammatory Demyelinating Polyneuropathy
RecruitingObservational study
Studying Nerve Function and Structure in Charcot-Marie-Tooth Disease, Anti-MAG Neuropathy and CIDP
Charcot-Marie-Tooth, CMT1A
Active, not recruitingPhase 2
A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves)
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
RecruitingPhase 2/3
Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Olga Titova contact
15 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gamunex-C and Xembify in people with CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy), run by Grifols Therapeutics LLC at 15 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Poland, Czechia, Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Duggan (+353 87 429 2411, sarah.duggan@grifols.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Week 1 to 19 of IV Phase). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.