A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease
Recruiting
Phase 3
Interventional Study
Graves' Disease
Graves Disease
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 230 (estimated)
- Sponsor
- argenx · Industry
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About This Trial
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 trea…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Is at least 18 years of age and the local legal age of consent for clinical studies when signing the ICF.
* Has a documented diagnosis of GD with TRAb (anti-thyrotropin receptor antibody) levels \>=ULN (upper limit of normal) at screening.
* Has active hyperthyroidism due to G…
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