Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Teprotumumab · 8 trials · 6 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: Teprotumumab | EXPERIMENTAL | Non-Japanese participants will receive SC injection of teprotumumab Dose A by a syringe pump. |
| Cohort 2: Teprotumumab | EXPERIMENTAL | Japanese participants will receive SC injection of teprotumumab Dose A by a syringe pump. |
| Cohort 3: Teprotumumab | EXPERIMENTAL | Non-Japanese participants will receive SC injection of teprotumumab Dose B by an injection device. |
| 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. |
| Name | Type | Description |
|---|---|---|
| Teprotumumab | BIOLOGICAL | SC injection |
| Placebo | OTHER | SC injection |
| normal saline | DRUG | - |
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...
Teprotumumab is an investigational drug being studied for thyroid eye disease, diabetic macular edema, and thyroid associated ophthalmopathies. It has also been evaluated in healthy volunteers for pharmacokinetic studies. The drug is in clinical development, with trials ranging from Phase 1 to Phase 2, and is not yet approved for any indication.
Teprotumumab is a monoclonal antibody, as indicated by its -mab suffix. It is being developed by Amgen Inc. for use in ophthalmology, specifically for conditions like thyroid eye disease and diabetic macular edema. The specific molecular target is not disclosed in the available clinical trial information.
Teprotumumab is developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker AMGN. Amgen is conducting clinical trials to evaluate the drug for thyroid eye disease, diabetic macular edema, and other thyroid-associated ophthalmopathies.
Teprotumumab is in Phase 1 clinical development, with one active trial and three completed trials. The completed trials include a Phase 2 study in thyroid eye disease and Phase 1 studies in diabetic macular edema and healthy volunteers. It remains investigational and is not FDA approved.
Teprotumumab has been studied in four clinical trials. NCT01868997 was a Phase 2 trial in active thyroid eye disease. NCT02103283 was a Phase 1 trial in diabetic macular edema. NCT06674941 and NCT07142642 were Phase 1 trials in healthy volunteers, with the latter specifically in Chinese participants.
Yes, Teprotumumab is also known as AMG 632, as referenced in the clinical trial NCT07142642. This trial evaluates the pharmacokinetics, safety, and tolerability of Teprotumumab (AMG 632) administered intravenously in healthy Chinese participants.