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NCT07540221 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Pharmacokinetics and Safety of XEMBIFY Versus Gamunex-C in Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
A Phase 3 study, sponsored by Grifols Therapeutics.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 40
- Enrollment target
NCT07540221 is a Phase 3 study that is actively recruiting participants, run by Grifols Therapeutics. The registered enrollment target is 40 participants.
The verdict
NCT07540221, a Phase 3 study, is actively recruiting participants, sponsored by Grifols Therapeutics.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 40 participants
- Enrollment target
Study 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.
Interventions
- BIOLOGICAL Gamunex-C
- BIOLOGICAL Xembify
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2026-04-02 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07540221
The ClinicalTrials.gov registry entry for NCT07540221 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Grifols Therapeutics, which has 34 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Gamunex-C is the first listed.
NCT07540221 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07540221 about?
NCT07540221 is a clinical study titled "A 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 sc...
What is the current status of trial NCT07540221?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 40 participants. The study started on 2026-04-02. Estimated completion is 2027-12-31.
What interventions are being tested in trial NCT07540221?
The interventions under investigation include: Gamunex-C (BIOLOGICAL), Xembify (BIOLOGICAL).
Who is sponsoring clinical trial NCT07540221?
This trial is sponsored by Grifols Therapeutics, which has 34 total clinical trials registered on ClinicalTrials.gov.
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