Phase 3: testing Gamunex-C for CIDP (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.
Official registry: https://clinicaltrials.gov/study/NCT07540221 · Grifols Therapeutics LLC · enrollment listed as 40
What this phase means
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Gamunex-C, or Xembify. The registry lists allocation as randomized. 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.
They plan to enroll about 40 people at 16 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.
Official title (unrewritten)
An Open-Label, Multicenter Study to Evaluate the Pharmacokinetics and Safety of XEMBIFY Versus Gamunex-C in Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Interventions: Gamunex-C, Xembify
Primary outcome (registry wording): 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
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- 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 the registry excludes
- 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
- known bleeding disorders
- severe skin disease at the planned injection sites
- alcohol, drug or medication abuse, or
Public study contact (from the registry)
Sarah Duggan
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
16 listed- GC2402 Study Site 104 — Rancho Mirage, California (recruiting)
- GC2402 Study Site 109 — Coral Springs, Florida (recruiting)
- GC2402 Study Site 105 — Miami, Florida (withdrawn)
- GC2402 Study Site 103 — Port Charlotte, Florida (recruiting)
- GC2402 Study Site 110 — New York, New York (recruiting)
- GC2402 Study Site 114 — Fayetteville, North Carolina (recruiting)
- GC2402 Study Site 111 — Cordova, Tennessee (recruiting)
- GC2402 Study Site 115 — Houston, Texas (recruiting)
- GC2402 Study Site 106 — Sherman, Texas (recruiting)
+ 7 sites outside the US on the same record
FAQ about this NCT record
Is NCT07540221 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07540221?
Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07540221?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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