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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: Recruiting Phase 3 study, sponsored by Grifols Therapeutics.
NCT07540221 is a Phase 3 study that is actively recruiting participants, run by Grifols Therapeutics. The registered enrollment target is 40 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What NCT07540221 shows while recruiting
NCT07540221 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Gamunex-C is the first listed.
NCT07540221 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07540221's enrollment target sits among peer trials
40 1878th of 2000 higher than 103 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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