A clinical trial of efgartigimod for Graves' Disease
(VitaliThy Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new study drug called efgartigimod, an experimental therapy for people with Graves' Disease, which causes the thyroid to become overactive. The study aims to understand how the study drug affects thyroid function and evaluates its safety. Participants will receive either the study drug or a placebo (inactive substance) in different stages. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants a chance to contribute to the development of a potential new treatment.
Do I need to stop my current medications for the trial?
The trial requires participants to be taking antithyroid drugs (ATD) and prohibits the use of certain medications like levothyroxine within 6 weeks prior to screening. You will be able to discuss your current medications with the study team.
Is there any evidence suggesting that efgartigimod is likely to be safe for humans?
Previous research has shown that efgartigimod is generally well-tolerated. It is approved for use in other auto-immune diseases.
Why do researchers think this study drug might be promising for Graves' disease?
In Graves' disease, the body's immune system makes antibodies that overstimulate the thyroid, causing it to produce too much thyroid hormone. Efgartigimod is designed to lower the levels of these antibodies. This approach is different from current antithyroid medicines, which work by reducing thyroid hormone production rather than targeting the antibodies themselves.
Are You a Good Fit for This Trial?
Adults aged 18+ with Graves' disease can join this study if they've signed the consent form and can follow the study plan.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial.
Study Drug Treatment
Participants will receive either Efgartigimod (study drug) or a placebo. Thyroid results will determine the participant's path and visit schedule.
Follow-up
Participants are monitored for safety after study drug treatment period.
What is the Study Drug Tested in This Trial?
Interventions
- Efgartigimod PH20 SC
Trial Overview
The study compares the study drug efgartigimod PH20 SC (given by prefilled syringe under the skin) to a placebo in adults with Graves' Disease. The trial has several phases, including double-blind treatment period and open-label treatment periods plus observation periods, lasting up to about 2.5 years depending on response.
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