Efgartigimod for Thyroid Eye Disease
(UplighTED Trial)
Trial Summary
The trial information does not specify if you need to stop taking your current medications, but it mentions that the use of some medications before screening is an exclusion criterion. It's best to discuss your current medications with the trial team to see if they affect your eligibility.
Efgartigimod PH20 SC is unique because it targets the immune system by reducing the levels of specific antibodies that contribute to thyroid eye disease, offering a novel approach compared to existing treatments like teprotumumab, which targets a different receptor involved in the disease process.
12345Eligibility Criteria
Adults with active, moderate-to-severe thyroid eye disease (TED) who've had symptoms start within the last year can join. They must be over 18, able to consent and follow the study plan, have their thyroid condition under control or only mildly off balance. Participants need to use birth control and women must test negative for pregnancy.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Double-Blinded Treatment Period
Participants receive efgartigimod PH20 SC or placebo PH20 SC in a double-blinded manner
Follow-up Observational Period
Participants are monitored for safety and effectiveness after treatment while off study drug
Open-label Treatment Period
Participants may opt into continuation of treatment with efgartigimod PH20 SC
Participant Groups
Efgartigimod PH20 SC is already approved in European Union, United States, Japan, China for the following indications:
- Generalized myasthenia gravis in adults who are anti-acetylcholine receptor antibody positive
- Generalized myasthenia gravis in adults who are anti-acetylcholine receptor antibody positive
- Chronic inflammatory demyelinating polyneuropathy (CIDP)
- Generalized myasthenia gravis in adults who are anti-acetylcholine receptor antibody positive
- Generalized myasthenia gravis in adults who are anti-acetylcholine receptor antibody positive