What is AMG 732 studying for Thyroid Eye Disease?

AMG 732 is being studied to understand its safety and how well it works for people with moderate-to-severe active Thyroid Eye Disease. Researchers want to see if multiple doses can improve eye symptoms and quality of life. The study is sponsored by Amgen and aims to gather important data for this condition.

Who may be eligible for this Thyroid Eye Disease clinical trial?

Adults aged 18 to 65 with moderate-to-severe active Thyroid Eye Disease may be eligible. Participants should have had active disease onset within 15 months and meet certain health criteria. Both men and women can join, though women must be non-childbearing if in Phase 1. Please review eligibility criteria for more details.

Is there any cost to participate in this Thyroid Eye Disease clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or related costs.

Actively Recruiting

Phase 1

Phase 2

Age: 18Years - 65Years

All Genders

Healthy Volunteers

ID06401044

A Phase 12, Randomized, Double-Masked, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of AMG 732 in Healthy Adults and Adults With Moderate-to-Severe Active Thyroid Eye Disease

Led by Amgen · Updated on 2026-05-15

Participants Needed

Research Sites

24 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety, tolerability, and effectiveness of AMG 732 in both healthy individuals and people with moderate-to-severe active Thyroid Eye Disease TED. The study is divided into two parts Part A focuses on single subcutaneous doses to assess safety, while Part B investigates multiple doses to evaluate efficacy in improving eye symptoms related to TED. This study includes participants aged 18 to 65 years and is sponsored by Amgen. Participants in Part A receive single ascending doses of AMG 732 or placebo through subcutaneous injections in six different groups. Part B participants receive either low, medium, or high doses of AMG 732 or placebo, also by subcutaneous injection, over approximately six months. The study involves randomized assignment to treatment groups and uses a double-masked design to ensure unbiased results. Throughout the study, participants undergo various assessments including monitoring of adverse events, blood tests to measure AMG 732 levels and antibodies, eye examinations measuring proptosis, and quality of life questionnaires related to visual function and appearance. Safety and treatment effects are followed for up to 36 weeks in Part A and up to 48 weeks in Part B. The total duration and detailed evaluations aim to provide comprehensive data on AMG 732s impact on TED and healthy subjects.

CONDITIONS

Brief Title

A Study of AMG 732 in Healthy Participants and Participants With Thyroid Eye Disease

Who Can Participate

Age: 18Years - 65Years

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Male or female aged 18 to 55 years for Part A (Phase 1) and aged 18 to 65 years for Part B (Phase 2)
Female participants in Part A must be of non-childbearing potential
Body mass index (BMI) between 18 and 30 kg/m² at screening
Ability to provide informed consent
Considered in good general health based on medical history, lab tests, vital signs, ECG, and physical exam
Healthy Japanese participants in Part A cohort 4 must meet specific ethnicity and residency criteria
For Part B: diagnosed with moderate-to-severe active Thyroid Eye Disease with onset within 15 months prior to baseline
Clinical Activity Score (CAS) ≥3 in the most affected eye at screening and baseline
Proptosis ≥18mm in the study eye at baseline
Baseline subjective binocular diplopia score greater than 0
Does not require immediate surgical eye intervention and is not planning corrective surgery or irradiation during the trial

You will not qualify if you...

Malignant condition within the past 12 months or major surgery within 8 weeks before screening or planned elective surgery during the study
Active liver or kidney dysfunction at screening
Positive hepatitis B, hepatitis C, or HIV test at screening
Glycated hemoglobin (HbA1c) > 6.5% or fasting glucose > 126 mg/dL at screening
Use of any steroid (IV, oral, eye drops) within 3 weeks prior to first dose, except for topical/inhaled steroids or short-course asthma steroids
Known hypersensitivity to teprotumumab or other monoclonal antibodies
History of substance abuse within 12 months before screening
Recent blood donation, significant blood loss, transfusion within 60 days or plasma donation within 7 days prior to dosing
For Part A: blood pressure or ECG abnormalities at screening
For Part B: use of steroids or immunosuppressive agents within 3 months prior to first injection
Prior use of teprotumumab or IGF-1R inhibitors
Prior orbital irradiation or decompression in the study eye
History or existing inflammatory bowel disease such as ulcerative colitis or Crohn's disease
Other protocol-defined criteria may apply

Research Team

Amgen Call Center

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