Actively Recruiting
An Open-label, Rollover Study to Evaluate AMG 732 in Adults With Thyroid Eye Disease Who Are Primary Non-responders or Relapsed After Prior Amgen Treatment
Led by Amgen · Updated on 2026-05-26
30
Participants Needed
1
Research Sites
23 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating AMG 732 in adults with thyroid eye disease (TED) who did not respond initially or relapsed after treatment in a previous Amgen trial. This Phase 2 open-label rollover study aims to assess the efficacy and safety of AMG 732 in this specific group of participants. The focus is on patients with moderate-to-severe TED who completed prior Amgen-sponsored AMG 732 studies and require further assessment of treatment response. Participants will receive AMG 732 as a subcutaneous injection. This trial does not use a placebo and involves a single treatment arm where all participants are given AMG 732. The study monitors participants over a 24-week period to evaluate their response, focusing on changes in proptosis (eye bulging). Additional safety monitoring will continue up to 48 weeks. During the study, participants will undergo various assessments including proptosis measurements by exophthalmometer, blood tests for AMG 732 drug levels, and monitoring for adverse events. Researchers will track the number of participants who respond to treatment and changes in eye bulging compared to baseline. Participants are expected to maintain euthyroid status and use contraception during and for six months after treatment. The total duration of involvement can be up to 48 weeks, including safety follow-up.
CONDITIONS
Brief Title
An Open-label, Rollover Trial to Evaluate the Efficacy and Safety of AMG 732 in Participants With Thyroid Eye Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent agreeing to study requirements
- Age 18 years or older at time of signing consent for the parent trial
- Moderate-to-severe thyroid eye disease at parent trial enrollment without need for immediate eye surgery
- Ability to maintain normal thyroid hormone levels (euthyroid status) during the trial
- Use protocol-specified contraception during treatment and for 6 months after last dose
- Completed a prior Amgen-sponsored AMG 732 clinical trial
You will not qualify if you...
- Prior orbital irradiation or decompression in the study eye
- Prior adult strabismus surgery
- Use of steroids or other immunosuppressive agents (except trial drug) within protocol-specified months prior to study drug injection
- HbA1c over 6.5% or fasting glucose above 126 mg/dL at screening
- History of cancer within 5 years or major surgery within 8 weeks or planned elective surgery during study
- Active liver or kidney dysfunction at screening
- Positive test for hepatitis B/C or HIV at screening
- Known allergy to teprotumumab, AMG 732, or similar antibodies
- Prior adverse event related to AMG 732 requiring drug interruption or discontinuation in parent study
- Recent blood donation, significant blood loss, transfusion, or plasma donation within specified timeframes before dosing
- History or current inflammatory bowel disease (ulcerative colitis or Crohn's disease)
- Other protocol-specified criteria as applicable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive AMG 732 administered subcutaneously to evaluate efficacy and safety for thyroid eye disease.
Regular visits for dosing and assessments throughout 24 weeks
Duration - Up to 24 weeks after treatment
Participants are monitored for safety and adverse events after completing treatment.
Visits up to Week 48 to monitor safety
Trial Site Locations
Total: 1 location
1
Applied Research Center of Arkansas
Little Rock, Arkansas, United States, 72205
Actively Recruiting
Research Team
A
Amgen Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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