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AMG 732 in Patients With Thyroid Eye Disease Who Did Not Respond or Relapsed After Previous Treatment

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at Thyroid Eye Disease, a condition in which the tissues around the eyes become swollen and the eyes may bulge forward. The treatment being studied is AMG 732, given as an injection under the skin. The purpose of the study is to see how well and how safely AMG 732 works in people whose eye disease did not improve enough before or came back after earlier treatment.

This is an open-label study, which means the treatment is known to the study team and the participants. People in the study will continue receiving AMG 732 for a period of time and will have regular study visits over the course of the trial. During these visits, the study team will check for any side effects and follow changes in the eye condition. The study is planned to run for a number of years.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Start of the study

    You enter an open-label study, which means that the study treatment is known and not hidden.

    This study is for people with thyroid eye disease (a condition that affects the eyes and is linked to thyroid disease) who previously took part in AMG 732 studies and either did not respond at first or later had their symptoms return.

  2. Step 2

    Study treatment

    You receive AMG 732, given as an injection under the skin.

    The listed dose is 9999 mg per administration.

    The source information does not state how often the injections are given or how long treatment lasts.

  3. Step 3

    Monitoring during the study

    Your eye condition is checked during the study to see whether there is a response to treatment.

    The main check is whether the eye that is being studied shows a decrease in proptosis (forward bulging of the eye) by at least 2 mm from the starting point, without a worsening of the other eye by 2 mm or more.

    Eye measurements are taken with an exophthalmometer, which is a tool used to measure how far the eye sticks out.

    The study also records how the body handles the medicine, including blood levels over time and the highest level reached after a dose.

    The study records any side effects, including serious side effects, side effects that cause the study medicine to be stopped, and other events of interest.

  4. Step 4

    Later study assessment

    A main study result is assessed at week 9999.

    At that time, the study checks whether you meet the definition of a responder in the study eye and whether the eye measurement has changed from the starting point.

  5. Step 5

    End of the study

    The study is planned to end by 2028-07-14.

Who can join the trial?

8 criteria

  • Be a participant who completed the Amgen-sponsored clinical trial of AMG 732.
  • Have thyroid eye disease (TED) that was moderate to severe when enrolled in the parent study. Moderate to severe means the eye disease was significant, but did not need urgent surgery.
  • Not need immediate surgical eye treatment at the time of enrollment in the parent study.
  • Not be planning corrective eye surgery or irradiation during the rollover trial. Irradiation means treatment with radiation.
  • Have signed informed consent, which means agreeing to join the study after being told about it.
  • Be at least 18 years old when signing informed consent for the parent study.
  • Have any worsening in thyroid function corrected so that the participant stays euthyroid during the entire rollover study. Euthyroid means the thyroid hormone levels are kept in the normal range.
  • Use the study-required contraception during treatment and for 6 months after the last dose of the study treatment. Contraception means methods used to prevent pregnancy.

Who cannot join the trial?

30 criteria

  • Corneal decompensation in the study eye that does not improve with medical treatment. This means the clear front part of the eye is no longer working properly and medicines have not helped.
  • Being unlikely, in the judgment of the participant or the investigator, to complete all required study visits, tests, rules, and procedures.
  • Having any other serious medical problem, condition, or disease that the investigator thinks could make the study unsafe.
  • Having active liver disease, liver dysfunction (poor liver function), or kidney dysfunction (poor kidney function) at screening, including:
    • ALT or AST blood tests more than 3 times the upper limit of normal. ALT and AST are liver enzymes; high levels can mean liver injury or inflammation.
    • Glomerular filtration rate of 30 mL/min/1.73 m² or less. This is a measure of how well the kidneys filter blood.
    • Being pregnant, having a positive pregnancy test, breastfeeding, planning to become pregnant, planning to donate eggs, or planning to breastfeed during the study and for 6 months after the last dose of study drug.
    • Being a woman who can become pregnant and not willing to use the required contraception during treatment and for 6 months after the last dose. Contraception means methods used to prevent pregnancy.
    • Being a man with a female partner who can become pregnant and not willing to either avoid heterosexual sex or use contraception during treatment and for 6 months after the last dose.
    • Being a man with a pregnant partner and not willing to avoid sex or use a condom during treatment and for 6 months after the last dose.
    • Being a man and not willing to avoid donating sperm during treatment and for 6 months after the last dose.
    • Having had a side effect thought to be related to AMG 732 in the parent study that required the study drug to be stopped or paused.
    • Having had orbital irradiation or orbital decompression in the study eye during or after the parent study. Orbital irradiation means radiation treatment to the eye area. Orbital decompression means surgery to make more space behind the eye.
    • Having a known positive HIV test at screening or within the last 12 months. HIV is the virus that causes AIDS.
    • Having had adult strabismus surgery. Strabismus surgery is surgery to correct eye misalignment.
    • Planning to use another investigational agent during the study. An investigational agent is a treatment still being studied and not fully approved for general use.
    • Having any new disease problem or major abnormal lab result during the parent study that the investigator thinks could make participation too risky.
    • Having a known allergy or sensitivity to any product or ingredient used during dosing.
    • Having had malignancy (cancer) within the last 5 years, except for certain cancers that were fully treated: nonmelanoma skin cancer, cervical carcinoma in situ, or breast ductal carcinoma in situ. Carcinoma in situ means very early cancer that has not spread.
    • Having donated blood, had major blood loss, received a blood transfusion, or received a plasma donation within 9999 days before day 1 dosing.
    • Having used steroids by mouth, injection, or vein, or steroid eye drops within 9999 weeks before the first dose, or starting these treatments during the study. Steroids are medicines that reduce inflammation. Topical steroids not used in the eye and inhaled steroids for other conditions are allowed, and short courses for injection reactions or asthma worsening are allowed.
    • Having received any mAb other than the study drugs in the parent study within 9999 months before the first dose. mAb means monoclonal antibody, a type of targeted medicine made in a laboratory.
    • Using selenium during the rollover study or within 9999 weeks before the first dose, unless it is only a multivitamin with a very small amount of selenium. Selenium is a mineral found in some supplements.
    • Having a current or past viral hepatitis infection that is active:
      • Active hepatitis C, meaning hepatitis C virus is present in the blood above the allowed level.
      • Active hepatitis B, meaning hepatitis B virus is present in the blood above the allowed level.
      • Having had an adverse event of hearing impairment during the parent study that has not recovered. Hearing impairment means reduced hearing.
      • Having had major surgery within 8 weeks before the first dose, or planning elective surgery from screening through the end of study. Elective surgery means planned surgery that is not urgent.
      • Having a history of inflammatory bowel disease, such as ulcerative colitis or Crohn’s disease. These are long-term diseases that cause swelling and irritation in the digestive tract.
      • Having a known allergy or strong reaction to any component of TEPEZZA, AMG 732, or to other fully human monoclonal antibodies. Fully human monoclonal antibodies are laboratory-made targeted medicines designed to be very similar to human antibodies.
      • Having received rituximab, tocilizumab, or any other non-steroid immunosuppressive medicine during or after the parent study. Immunosuppressive medicines lower the activity of the immune system.
      • Having received any other investigational agent for any condition, including thyroid eye disease, after the parent study ended.
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Investigated drugs

AMG 732 is the study medicine being tested in this trial. It is given as an injection under the skin and is being studied in people with thyroid eye disease who did not respond well enough before or who improved and then got worse again after the earlier study. The goal of the trial is to see how well this medicine helps reduce the eye problems caused by thyroid eye disease.

What is already known about the treatment

AMG 732 - AMG 732 is given as a solution for injection under the skin, which means it is administered by subcutaneous injection. It is an investigational medicine, so it is still being studied and is not yet an established treatment in routine medical practice or widely described in standard medical references. It is being tested for thyroid eye disease, a condition that can cause swelling and bulging of the eyes, especially in people who do not respond well to earlier treatment or who relapse after it. Its exact molecular action is not fully public, but as a targeted study drug it is designed to block a specific disease-related signal in the body, and it belongs to the class of experimental biologic therapies.

Investigated diseases

Thyroid Eye Disease - Thyroid eye disease is a condition in which the tissues around the eyes become inflamed and swollen, often causing the eyes to look pushed forward. It usually develops in stages, with an active phase when swelling and irritation are more noticeable, followed by a more stable phase when the changes slow down. The condition can affect one or both eyes and may cause the eyes to feel dry, gritty, or tight, with changes in how they open or move. Over time, the swelling may lessen, but some changes in eye appearance or movement can remain.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-523280-38-00Protocol code20230294.01Estimated enrolment34 patientsSponsorAmgen Inc.

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