Purpose of this Study
In this study, people will be randomly chosen to get either a medicine called efgartigimod or a placebo. A placebo looks like the real medicine but does not have any medicine in it. It is used to help compare results.
There is a 67% chance of getting efgartigimod and a 33% chance of getting the placebo. That means twice as many people will get the real medicine.
The study will last about 1 to 2 years, depending on how each person reacts to the medicine. People will need to visit the study clinic up to 20 times for tests and check-ups.
Who Can Participate?
Eligibility
People in this study must:
- Be 18 years old or older.
- Have active Thyroid Eye Disease (TED) that is linked to Graves' disease or Hashimoto's thyroiditis.
- Not have had radiation or surgery to treat TED before.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study is trying to find out if a new medicine called efgartigimod can help people who have Thyroid Eye Disease, or TED. The study also wants to make sure the medicine is safe for people to use.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A Phase 3, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Efgartigimod PH20 SC Administered by Prefilled Syringe in Adult Participants With Thyroid Eye Disease - UplighTED
Principal Investigator
Christopher
Dermarkarian
Protocol Number
PRO00118108
NCT ID
NCT06307626
Phase
III
Enrollment Status
Pending Open to Enrollment