BridgeMD
Tests treatment safety and results for Graves Disease
Official title A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease.
ClinicalTrials.gov ID: NCT07596849
What this study is testing
What is efgartigimod PH20 SC?
efgartigimod PH20 SC is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for graves disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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 GD with TSH (thyroid-stimulating hormone) \<0.1 mIU/L at screening
- Has been treated with MMI (methimazole) or CBZ (carbimazole) for at least 3 months before screening
You likely can't join if
- History of hyperthyroidism not caused by GD (eg, toxic adenoma or toxic multinodular goiter)
- History of RAI (radioactive iodine) therapy or received a total thyroidectomy
- T3- or T4-containing medication or supplement (eg, levothyroxine, liothyronine, desiccated thyroid preparations, or thyroid-support supplements)...
- Any complication of hyperthyroidism or underlying medical condition that would put the participant at undue risk. This includes arrhythmia or...
- Graves' orbitopathy/Thyroid Eye Disease (GO/TED) requiring systemic therapy (eg, corticosteroids), orbital injections, orbital surgery, or orbital...
The study team makes the final eligibility decision.
Where it's taking place
- Batumi, Georgia
- Tbilisi, Georgia
- Iizuka, Japan
- Kyoto, Japan
- Yokohama, Japan
- Yonago, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Batumi, Georgia; Tbilisi, Georgia; Iizuka, Japan; Kyoto, Japan; Yokohama, Japan; Yonago, Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.