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ARGX-113-2301 (UplighTED) - Clinical Trial

What is the 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.

What is the Condition Being Studied?

Thyroid Eye Disease

Who Can Participate in the Study?

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.

Grupo etario
Adultos

What is Involved?

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.

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
Especialista en cirugía plástica oculofacial
Protocol Number
IRB: PRO00118108
NCT: NCT06307626
Phase
Phase III
ClinicalTrials.gov
Estado de inscripción
Pronto disponible para inscripción