A Phase 2 Study to Assess AMG732 in Participants with Thyroid Eye Disease (Part B)
Research type
Research Study
Full title
A Phase 1/2, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study to Assess the Safety, Pharmacokinetics, and Efficacy of AMG 732 in Healthy Subjects and Subjects with Moderate-to-Severe Active Thyroid Eye Disease
IRAS ID
1012681
Contact name
Matthew Rodaway
Contact email
Sponsor organisation
Amgen Inc.
Eudract number
2024-514110-12
Clinicaltrials.gov Identifier
Research summary
This is a Phase 2 study, an early stage of the development process for new medicines. This study is being done to learn more about how effective a new medicine is for participants with moderate to severe Thyroid Eye Disease (TED; a disorder of the eye). TED is an illness where the immune system (the body’s defense against infections) attacks the muscles supporting eyeballs and fat around the eyes that help in the movement and alignment of eye causing them to become thick and stiff. This leads to bulging of eyes, double vision, and blindness in some severe cases. Participants will be randomly assigned into one of two different groups to receive either the study medicine, or a placebo that looks like the study product, and is administered the same way, but has no active ingredients. 75% of participants will receive either low, medium, or high doses of the study product, while 25% will receive placebo. The study may last up to 1 year for each participant, including a screening period of up to 28 days. Participants will receive a subcutaneous injection into the abdomen 6 times, spaced 4 weeks apart. The study will include men and non-pregnant women aged between 18 and 65 that currently have moderate to severe TED. Participants must be considered healthy enough to receive the study treatment, and will have various other procedures and reviews of their medical histories to confirm this before they are allowed onto the treatment stage of the study. Participants who have active Irritable Bowel Disease, Ulcerative Colitis or Crohn’s disease will not be able to take part.
REC name
London - Harrow Research Ethics Committee
REC reference
25/LO/0771
Date of REC Opinion
8 Dec 2025
REC opinion
Further Information Favourable Opinion