Efgartigimod for Thyroid Eye Disease
(UplighTED Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment called efgartigimod PH20 SC for individuals with thyroid eye disease (TED), a condition often linked to thyroid issues that can cause the eyes to bulge or become irritated. The trial aims to evaluate the effectiveness and safety of efgartigimod PH20 SC compared to a placebo. Participants will receive either efgartigimod PH20 SC or a placebo to assess the treatment's effectiveness. This trial suits those with moderate-to-severe TED symptoms for less than a year and normal thyroid function or mild thyroid issues. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.
Do I have to stop taking my current medications for the trial?
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.
Is there any evidence suggesting that efgartigimod PH20 SC is likely to be safe for humans?
Research has shown that efgartigimod PH20 SC is generally well-tolerated. Previous patients demonstrated that this treatment usually does not cause serious side effects. In other studies with efgartigimod, most participants did not experience severe negative effects. Common side effects were mild, such as headaches or injection site reactions.
Since efgartigimod PH20 SC is now in a Phase 3 trial, earlier trials have already assessed its safety, suggesting it is safe for use in humans. Additionally, efgartigimod is approved for other conditions, which supports its safety profile. However, it is important to consult a doctor to understand the risks and benefits before joining a trial.12345Why do researchers think this study treatment might be promising for TED?
Unlike the standard treatments for Thyroid Eye Disease, which often include corticosteroids or surgical interventions, Efgartigimod PH20 SC works by targeting a different pathway. This treatment is unique because it modulates the immune response by reducing the levels of pathogenic immunoglobulin G (IgG) antibodies, potentially leading to a more direct and precise approach to reduce inflammation and symptoms. Researchers are excited about Efgartigimod because it is administered subcutaneously, which can be more convenient and less invasive than other forms of treatment. This novel mechanism of action and delivery method could offer patients a new, effective option with potentially fewer side effects.
What evidence suggests that efgartigimod PH20 SC might be an effective treatment for thyroid eye disease?
Research has shown that efgartigimod PH20 SC, which participants in this trial may receive, might help treat Thyroid Eye Disease (TED). This treatment reduces certain antibodies that cause swelling and irritation around the eyes. In earlier studies, patients who used efgartigimod experienced improvements in symptoms, such as reduced eye bulging and discomfort. Administered as an injection just under the skin, the treatment might be easier to use. While more information is needed, these findings suggest efgartigimod could be a promising option for people with moderate-to-severe TED.23456
Are You a Good Fit for This Trial?
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
Timeline for a Trial Participant
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
What Are the Treatments Tested in This Trial?
Interventions
- Efgartigimod PH20 SC
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
argenx
Lead Sponsor
Tim Van Hauwermeiren
argenx
Chief Executive Officer since 2008
B.Sc. and M.Sc. in Bioengineering from Ghent University, Executive MBA from The Vlerick School of Management
Dr. Peter Ulrichts
argenx
Chief Medical Officer since 2023
MD from Maastricht University, PhD in Molecular Immunology from Maastricht University