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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05683496 | Efficacy and Safety of Lonigutamab in Subjects With Thyroid Eye Disease (TED) | PHASE1 | COMPLETED | 31 | — | — | Feb 14, 2023 | May 26, 2025 | Jul 1, 2025 | 11 | United States, Australia |
Safety and Tolerability
Safety and Tolerability
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Single SC injection of dose 1 of lonigutamab or placebo at Day 1 and Day 21 |
| Cohort 2 | EXPERIMENTAL | multiple doses of dose 2 of lonigutamab administered SC injection weekly |
| Cohort 3 | EXPERIMENTAL | multiple doses of lonigutamab dose 3 administered SC injection every 4 weeks. |
| Cohort 4 | EXPERIMENTAL | multiple doses of lonigutamab dose 4 administered SC injection every 4 or 3 weeks. |
| Name | Type | Description |
|---|---|---|
| lonigutamab | DRUG | subcutaneous injection |
| Placebo | DRUG | subcutaneous injection |
Key Inclusion Criteria: * Male or female, ≥18 and ≤75 years of age. * Proptosis defined in the study eye as ≥3 mm above normal. * Clinical Activity Score (CAS) ≥4 (using a 7-item scale) for the most severely affected eye * Onset of active TED symptoms prior to baseline * Must agree to use highly ef...