Clinical Study in Thyroid Eye Disease (TED)
Phase 3 Study to Evaluate the Safety and Efficacy of an Investigational Study Drug for Self-Injection for Thyroid Eye Disease (TED)
About TED
Thyroid Eye Disease, also known as Graves’ Eye Disease, is an autoimmune disorder affecting the muscles and tissues around the eyes.
About The Study
This study aims to evaluate the effectiveness and safety of an investigational study drug given by a subcutaneous injection.
Participation
There are three steps involved in participating in the UplighTED study.
Thyroid Eye Disease
CLINICALTRIALS.GOV ID: NCID NCT06307626 | NCT06307613
Can You Participate?
About Thyroid Eye Disease (TED)
Thyroid Eye disease, also known as Graves’ Eye Disease, is an autoimmune disorder affecting the muscles and tissues around the eye. In its active phase, swelling and bulging can cause pain and affect vision. TED can go into an inactive phase, during which some symptoms improve, but eye bulging can persist. Effective treatments are needed to improve the symptoms caused by TED.
Study Design
Study Design Influenced by People with TED
To design this protocol, researchers asked for input from people with TED and their care partners in multiple countries in the European Union (including the UK) and in the US.
Their input helped researchers better understand what it is like to live with TED, which in turn helped researchers to design the study.
A patient advisory panel was also convened to obtain feedback on specifically, the mode and length of collecting participant’s experience with the treatment and their status during the study.
About the Study
In this study, the study drug is delivered through a pre-filled syringe which can be self-injected, or injected by a caregiver just under the skin. The main goals of this study are to learn about the effect of the investigational study drug compared with placebo on eye symptoms and quality of life, and about the safety of the investigational study drug in adult participants with TED. Participants will be randomly assigned to 2 groups: one receiving the active study drug and one receiving placebo (a syringe filled with placebo looks like the investigational study drug but does not contain the active ingredient). The study will last 1 to 2 years.
About the Study Medication
The study drug is being investigated as a potential therapy in multiple autoimmune diseases because it has been shown to reduce autoantibodies (harmful antibodies in the blood that will attack healthy tissues). The study drug is different from current treatments available for TED and it can be self-injected into the abdomen and thigh, and does not require an infusion.
How do You Know if the Study is Right For You?
Please see the following criteria provided by the researchers for participation. You can print this out and share with your specialist, who can help determine whether the study is appropriate for you at this time.
To qualify for participation, you must have all of the following:
Be at least 18 years of age
Be capable of providing signed informed consent, and complying with protocol requirements
Have received a diagnosis of active, moderate-to-severe TED associated with autoimmune thyroid disease (Graves’ disease or Hashimoto’s thyroiditis)
Have active symptoms such as redness, swelling, or pain of the eye or around the eye in the last 12 months, or recent worsening of the eye bulge
Have hyperthyroidism or thyroid disease that is considered under control
The study may not be appropriate for you if the following applies:
You are currently participating in any clinical study with an investigational drug or intervention
You have optic neuropathy, as defined by a decrease in vision or a new visual field defect, or another defect within the past 6 months prior to screening
You are currently using steroids within 4 weeks of screening
You are currently taking other medications such as immunosuppressants, monoclonal antibodies in a certain number of weeks before screening
You have received radioactive treatment for Graves’ disease within the past 6 months
You’ve had previous orbital irradiation or surgery for TED or immediate planned eye surgery
You have other autoimmune conditions or eye conditions which might interfere with the assessments of the study drug
Participation
There are three steps involved in participating in the UplighTED study.
Potentially eligible participants who sign the informed consent form (ICF) will begin to be screened for the study. If they are determined to be eligible, participants will be assigned either treatment with the active investigational study drug delivered in an injection through a prefilled syringe or a placebo delivered in the same way.
There will be 2 groups in the study, one group being given the investigational study drug and one group given a prefilled syringe with a placebo (the placebo looks like the investigational study drug but does not contain the active ingredient). The treatment (either the syringe with the active investigational study drug or the syringe with the placebo) will be administered once weekly during the treatment period of the study.
After the last treatment, those who did experience a reduction in the swelling or bulging will continue to be monitored for the effects of the study drug after they’ve stopped taking the study drug. Those who did not respond during the treatment period can continue in the study for an extended period, and receive the active investigational study drug, while being monitored for response.
Can You Participate?
Study Centre Locations
FAQs
How do I know if I have Thyroid Eye Disease?
Thyroid Eye Disease is an autoimmune disease that is diagnosed by examination and through blood tests. Some people are diagnosed by an endocrinologist with thyroid conditions like Graves’ Disease or Hashimoto’s Disease but also have TED (or Graves’ Eye Disease). Others experience the eye symptoms like proptosis (bulging eyes) and are diagnosed by an ophthalmologist. If you are diagnosed with TED, you may be referred by your physician to an ophthalmologist who specializes in TED.
What does ‘active disease’ mean as a qualification for the study?
When the participant is affected by the symptoms of TED such as redness, bulging eyes and blurry vision, it is considered ‘active’.
Why should I consider joining a clinical study for TED?
According to the National Institutes of Health, there are three reasons why people choose to participate in a clinical study:
A chance to access a potential therapy and to be highly monitored for your individual response
To come under the care of the leading specialists in TED on an ongoing basis for the course of the study
To personally contribute to the development of new treatments that can benefit people like yourself with TED
How do I participate in the study?
You can download the study fact sheet and share it with your specialist. The fact sheet provides a QR code for the specialist that leads to more detailed information about the study. If your specialist feels the study would be appropriate for you, he or she can contact the study’s team who can help connect you to the study.
Are there any costs to participate?
Participants will not be charged for study visits or for the medications given as part of the study. Travel to study sites for treatments may be reimbursed.
What happens if I join but then decide the study is not right for me?
Participating in a clinical study is voluntary, allowing individuals control over their decision to join. Participants are able to withdraw from the study at any time. However, participants should recognize the responsibilities involved and consider whether they can meet the requirements before joining a study. Study centres aim to provide confidence by ensuring your questions are answered and expectations are clear.
Download the Study Fact Sheet to share with your specialist
Sources:
1. https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/graves-eye-disease 2. Szelog J, et al. Mo Med. 2022 Jul-Aug; 119(4): 343–350. 3. clinicaltrials.gov ID: NCT06307626 and NCT06307613. 4. Dolman PJ. “Grading Severity and Activity in Thyroid Eye Disease.” Ophthal Plast Reconstr Surg 2018;34:S34–S40. 5. https://www.nih.gov/health-information/nih-clinical-research-trials-you/basics
UplighTED Study Patient Website_CMS_MED-EU-ESC-2400004_UK_V3_29.05.2025
