Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Linsitinib · 1 trial · 12 indications
Proptosis response is defined as a ≥ 2 mm reduction from Baseline in the primary study eye without deterioration (≥ 2 mm increase) of proptosis in the contralateral non-study eye.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo Arm |
| Low Dose | ACTIVE_COMPARATOR | Active Arm Low Dose Linsitinib |
| High Dose | ACTIVE_COMPARATOR | Active Arm High Dose Linsitinib |
| Name | Type | Description |
|---|---|---|
| Linsitinib | DRUG | Study medication taken twice daily by mouth |
| Placebo | DRUG | Placebo taken twice daily by mouth |
Inclusion Criteria: * Clinical diagnosis of Graves' Disease and/or autoimmune Hashimoto's thyroiditis associated with active moderate to severe TED with a CAS ≥ 4 (on the 7- item scale) for the most severely affected eye (primary study eye) at Screening and Baseline * Confirmed active TED (not sigh...