Exploring the UplighTED Study: A New Hope in Treating Thyroid Eye Disease

If you or someone you know is considering participation in a clinical study evaluating treatment options for managing Thyroid Eye Disease (TED), the UplighTED Study may be an option. The study is evaluating an investigational study drug, administered once a week, for its efficacy, safety, and tolerability in TED.

What is Thyroid Eye Disease (TED)?

• Thyroid Eye Disease (TED) is sometimes called Graves’ Eye Disease.

• TED is an autoimmune disorder that affects the muscles and tissue around the eyes.

• In the active phase, swelling and bulging can cause pain and may affect vision.

• In the inactive phase, some symptoms may improve; however, eye bulging can persist.

• There is an unmet need in the management of the symptoms of TED.

How Was the Study Designed?

The UplighTED Study was designed in part from patients with TED. Their input helped researchers better understand what it is like to live with TED. A panel of patients were gathered where they provided feedback to researchers which helped to inform the study design. They shared with researchers symptoms they thought should be evaluated in the study to determine efficacy.

Study Design and Participation Details

• The study will evaluate the safety and efficacy of an investigational study drug compared to placebo (a substance that resembles the study drug but has no active ingredients) in adults with TED.

• Two out of three participants will receive the investigational study drug.

• One out of three participants will receive the placebo.

• Both the study drug and placebo are provided in prefilled syringes and administered via subcutaneous (under the skin) injection.

• Participants may choose to self-inject or have a caregiver perform the weekly injections.

• Participants may request a home nurse to assist with drug administration at home.

• The study may last up to two years.

What Happens After 24 Weeks?

• Study participants who are considered responders (i.e., show a reduction in the bulging of the eye at 24 weeks of treatment) will stop the investigational drug or placebo and be monitored for safety for 52 weeks.

• Participants who are considered non-responders (i.e., do not show a reduction in the bulging of the eye after the first 24 weeks of treatment) or those who have worsening during the follow-up, may be eligible to enter the open label study where they will receive the investigational drug and be evaluated for safety and response to treatment.

Is This Study Right for You?

To qualify for participation, you must have all of the following*:

1. Be at least 18 years of age

2. Be capable of providing signed informed consent and complying with study requirements

3. Have received a diagnosis of active, moderate-to-severe TED associated with autoimmune thyroid disease (Graves’ disease or Hashimoto’s thyroiditis)

4. Have onset of active symptoms such as redness, swelling, or pain of the eye or around the eye within the last 12 months, or recent worsening of the eye bulge

5. Have hyperthyroidism or thyroid disease that is considered under control

*Study team members will determine if any of these apply to you

The study may not be appropriate for you if the following applies*:

1. You are currently participating in any clinical study with an investigational medication or intervention

2. You have optic neuropathy, as defined by a decrease in vision or a new visual field defect, or another defect within the past six months prior to screening

3. You stopped corticosteroids (also referred to as steroids), immunosuppressants (medicines that suppress your immune system) or monoclonal antibodies less than four weeks prior to screening

4. You are currently taking other medications such as corticosteroids, immunosuppressants or monoclonal antibodies which you cannot stop

5. You have received radioactive treatment for Graves’ disease within the past 6 months

6. You’ve had previous orbital irradiation or surgery for TED or immediate planned eye surgery

7. You have other autoimmune conditions or eye conditions which might interfere with the assessments of the study drug

*Study team members will determine if any of these apply to you

Ready to Learn More?

To review the full study details and check if you might be eligible, determine if you may be eligible for the UplighTED Study.

(U.S. residents only.)

Why This Matters

This Phase 3 clinical trial represents a meaningful step toward new, accessible treatments for people with moderate-to-severe TED. Not only was the study designed with significant patient input—ensuring that real-life concerns were addressed—it also offers flexibility in administration, including self-injection and home care options.

If you're exploring treatment options for TED, talking with your specialist about potentially participating in the UplighTED Study could open the door to a new path in managing this challenging condition.