Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication TEPEZZA is indicated for the treatment of Thyroid Eye Disease regardless of Thyroid Eye Disease activity or duration. TEPEZZA is an insulin-like growth factor-1 receptor inhibitor indicated for the treatment of Thyroid Eye Disease ( 1 ) FDA label
Also known as HZN-001, Teprotumumab, Teprotumumab-trbw, AMG 632
TEPEZZA · 7 trials · 7 indications
Proptosis responders were defined as participants with a ≥ 2 mm reduction from study baseline in proptosis in the study eye, without deterioration (≥ 2 mm increase) of proptosis in the fellow eye at Week 24. Participants missing Week 24 values were considered non-responders, aside from those with missing data related to the COVID-19 pandemic.
Proptosis responders were defined as participants with a ≥2 mm reduction from Baseline in proptosis in the study eye, without deterioration (≥2 mm increase) of proptosis in the fellow eye at Week 24.
Number of participants classified as responders and non-responders at Week 24. Responders were defined as participants with a reduction in clinical activity score (CAS, see Outcome Measure 4 description for details) of ≥ 2 points, and a reduction in proptosis (amount of protrusion of the eye from the orbital rim) of ≥ 2 mm in the study eye, and no deterioration (increase in CAS of ≥ 2 points or increase in proptosis of ≥ 2 mm) in the non-study eye. Participants who had no assessment at 24 weeks were considered non-responders.
AUC will be evaluated from the collected PK samples.
Cmax will be evaluated from the collected PK samples.
An AE is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
Number of subjects with adverse events, serious adverse events and early discontinuations due to adverse events. Number of subjects with clinical significant abnormal laboratory values, electrocardiograms (pre and post infusions), abnormal vital signs, ophthalmic and physical examinations.
| Arm | Type | Description |
|---|---|---|
| Teprotumumab | EXPERIMENTAL | Teprotumumab administered SC |
| Placebo | PLACEBO_COMPARATOR | Placebo for teprotumumab administered SC |
| Teprotumumab 20 mg/kg | ACTIVE_COMPARATOR | Approximately 38 participants will receive 8 infusions of teprotumumab q3W for a total of 21 weeks. Teprotumumab 10 mg/kg will be administered on Day 1 and teprotumumab 20 mg/kg will be administered q3W for the remaining 7 infusions. |
| Cohort 1 | EXPERIMENTAL | Participants will receive a single dose of lyophilized teprotumumab by subcutaneous (SC) administration on Day 1 followed by intravenous (IV) infusions of teprotumumab at the approved dosing regimen. |
| Cohort 2 | EXPERIMENTAL | Participants will receive a single high concentration formulation teprotumumab by SC administration on Day 1 followed by IV infusions of teprotumumab at the approved dosing regimen. |
| Cohort 1: TEPEZZA Dose A SubQ | EXPERIMENTAL | Participants will receive Dose A of TEPEZZA administered SubQ. |
| Cohort 2: TEPEZZA Dose B SubQ | EXPERIMENTAL | Participants will receive Dose B of TEPEZZA administered SubQ. |
| Cohort 3: TEPEZZA Dose B Intravenously (IV) | EXPERIMENTAL | Participants will receive Dose B of TEPEZZA administered IV. |
| Cohort 4: TEPEZZA Dose B and EDP SubQ | EXPERIMENTAL | Participants will receive coadministered doses of TEPEZZA Dose B and EDP SubQ. |
| Name | Type | Description |
|---|---|---|
| Teprotumumab | BIOLOGICAL | SC injection |
| Placebo | OTHER | SC injection |
| normal saline | DRUG | - |
| TEPEZZA | DRUG | Administered as a SubQ injection or IV injection. |
| EDP | DRUG | Administered as a SubQ injection. |
Inclusion Criteria: 1. Participant must provide written informed consent. 2. Participant can be male or female and must be between the ages of 18 and 80 years, inclusive, at Screening. 3. Participant must have a clinical diagnosis of Graves' disease associated with active TED with a CAS ≥ 3 (on the...
TEPEZZA is an investigational small molecule developed by Amgen Inc. (ticker AMGN). It is being studied in a Phase 1 clinical program, with one completed trial to date. The trial evaluated subcutaneous administration of TEPEZZA in healthy adult volunteers in the United States.
TEPEZZA is developed by Amgen Inc., which trades under the ticker AMGN. Amgen is the sponsor of the clinical program studying the drug, including the completed Phase 1 trial of subcutaneous administration in healthy adults.
TEPEZZA is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The completed study enrolled 37 healthy adult volunteers and examined subcutaneous administration of the drug.
TEPEZZA has been studied in one completed Phase 1 trial, NCT06563856, titled A Study of TEPEZZA Subcutaneous Administration in Healthy Adults. The trial enrolled 37 participants in the United States and assessed bioavailability and bioequivalence in healthy volunteers aged 18 years and older.
TEPEZZA is an investigational drug in Phase 1 clinical development and is not described as approved. Its only listed trial, NCT06563856, is a completed Phase 1 study of subcutaneous administration in healthy adults, so the program remains at an early clinical stage.
The Phase 1 trial NCT06563856 studied subcutaneous administration of TEPEZZA in healthy adults. It enrolled 37 participants in the United States, used a controlled design without randomization or double blinding, and evaluated bioavailability and bioequivalence in volunteers aged 18 years and older.