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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: Recruiting Phase 3 study, sponsored by argenx.
NCT07570316 is a Phase 3 study that is actively recruiting participants, run by argenx. The registered enrollment target is 230 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Free triiodothyronine: \[fT3\]; free thyroxine: \[fT4\]; ATDs: antithyroid drugs
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 |
What NCT07570316 shows while recruiting
NCT07570316 is an interventional study that assigns participants to a tested intervention. The registered 230 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo PH20 SC is the first listed.
NCT07570316 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT07570316's enrollment target sits among peer trials
230 1304th of 2000 higher than 692 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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