Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06248619 | A Trial to Investigate Teprotumumab Subcutaneous Administration Compared With Placebo in Male and Female Adult Participants With Moderate-to-severe Active Thyroid Eye Disease | PHASE3 | ACTIVE NOT_RECRUITING | 89 | — | — | Jul 5, 2024 | Sep 2, 2026 | Jan 28, 2026 | 38 | United States, Argentina +9 |
| NCT03461211 | Treatment of Graves' Orbitopathy to Reduce Proptosis With Teprotumumab Infusions in an Open-Label Clinical Extension Study | PHASE3 | COMPLETED | 51 | — | — | Apr 16, 2018 | Feb 17, 2021 | Jun 28, 2024 | 13 | United States, Germany +1 |
| NCT03298867 | Treatment of Graves' Orbitopathy (Thyroid Eye Disease) to Reduce Proptosis With Teprotumumab Infusions in a Randomized, Placebo-Controlled, Clinical Study | PHASE3 | COMPLETED | 83 | — | — | Oct 4, 2017 | Nov 30, 2020 | Jul 11, 2024 | 14 | United States, Germany +1 |
| NCT06389578 | A Study of TEPEZZA® Treatment in Participants With Thyroid Eye Disease | PHASE1 | COMPLETED | 16 | — | — | Jul 14, 2022 | Sep 12, 2023 | Jun 21, 2024 | 3 | United States |
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.
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.
| 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. |
| Name | Type | Description |
|---|---|---|
| Teprotumumab | BIOLOGICAL | SC injection |
| Placebo | OTHER | SC 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...