Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT07570316 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease
A Phase 3 study, sponsored by argenx.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 230
- Enrollment target
NCT07570316 is a Phase 3 study that is actively recruiting participants, run by argenx. The registered enrollment target is 230 participants.
The verdict
NCT07570316, a Phase 3 study, is actively recruiting participants, sponsored by argenx.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 230 participants
- Enrollment target
Study Summary
The main purpose of this study is to look at how efgartigimod affects thyroid function in adults with Graves' Disease (GD). The study will also check whether efgartigimod is safe and well tolerated. It will look at how efgartigimod is distributed and eliminated in the body, how it changes antibody levels, and how the immune system responds to it. The study consists of a part A double-blinded treatment period, a part B treatment/observation period and a part C open-label treatment/observation period. During the part A and part B treatment periods, participants will receive efgartigimod PH20 SC via Prefilled Syringe (PFS) or placebo. During the part C open-label treatment period, participants will receive efgartigimod PH20 SC PFS. Participation in the different parts of the study will depend on the participant's response to treatment. The total study duration for participants ranges from 63 to 135 weeks, depending on the response to treatment. More information can be found here: https://clinicaltrials.argenx.com/vitalithy
Interventions
- OTHER Placebo PH20 SC
- BIOLOGICAL Efgartigimod PH20 SC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 230 participants |
| Start Date | 2026-06-10 |
| Est. Completion | 2030-05 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07570316
The ClinicalTrials.gov registry entry for NCT07570316 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 230 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is argenx, which has 49 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo PH20 SC is the first listed.
NCT07570316 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07570316 about?
NCT07570316 is a clinical study titled "A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease". The main purpose of this study is to look at how efgartigimod affects thyroid function in adults with Graves' Disease (GD). The study will also check whether efgartigimod is safe and well tolerated. It will look at how efgartigimod is distributed and eliminated in the body, how it changes antibody l...
What is the current status of trial NCT07570316?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 230 participants. The study started on 2026-06-10. Estimated completion is 2030-05.
What interventions are being tested in trial NCT07570316?
The interventions under investigation include: Placebo PH20 SC (OTHER), Efgartigimod PH20 SC (BIOLOGICAL).
Who is sponsoring clinical trial NCT07570316?
This trial is sponsored by argenx, which has 49 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.