Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AMG 732 · 2 trials · 1 indication
Responders are defined as participants with a ≥ 2 mm reduction from baseline in the trial eye without deterioration (≥ 2 mm increase) of proptosis in the fellow eye.
| Arm | Type | Description |
|---|---|---|
| AMG 732 | EXPERIMENTAL | Participants will receive AMG 732 subcutaneously (SC) |
| Part A: AMG 732 | EXPERIMENTAL | Participants in 6 cohorts will receive either AMG 732 or placebo in Single Ascending Doses (SAD). |
| Part A: Placebo | PLACEBO_COMPARATOR | Participants in 6 cohorts will receive either AMG 732 or placebo in Single Ascending Doses (SAD). |
| Part B: AMG 732 Low Dose | EXPERIMENTAL | Participants will receive AMG 732 low dose SC. |
| Part B: AMG 732 Medium Dose | EXPERIMENTAL | Participants will receive AMG 732 medium dose SC. |
| Part B: AMG 732 High Dose | EXPERIMENTAL | Participants will receive AMG 732 high dose SC. |
| Part B: Placebo | PLACEBO_COMPARATOR | Participants will receive placebo SC. |
| Name | Type | Description |
|---|---|---|
| AMG 732 | DRUG | AMG 732 will be administered SC. |
| Placebo | OTHER | SC injection |
Inclusion Criteria 1. Signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 2. Age ≥ 18 years at the time of signing informed consent for parent trial. 3. Moderate-to-severe TED at the time of enrollm...
AMG 732 is an investigational small molecule being developed for the treatment of Thyroid Eye Disease. It is currently in Phase 2 clinical development and is not yet approved by the FDA. The drug is being studied in adults aged 18 years and older.
AMG 732 is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in participants with Thyroid Eye Disease.
AMG 732 is in Phase 2 clinical development for Thyroid Eye Disease. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 2 program includes a rollover trial that is currently recruiting participants.
AMG 732 is being studied in two clinical trials. NCT06401044 is a Phase 1 study in healthy participants and those with Thyroid Eye Disease, which is active but not recruiting. NCT07438405 is a Phase 2 open-label rollover trial evaluating efficacy and safety, which is currently recruiting.
The clinical development program for AMG 732 includes randomized, double-blind, placebo-controlled trials. The Phase 1 study (NCT06401044) enrolls healthy volunteers and participants with Thyroid Eye Disease, while the Phase 2 rollover trial (NCT07438405) is open-label and recruiting participants.