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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07003425 | A Long-term Safety and Efficacy Study Evaluating APG777 in Atopic Dermatitis | PHASE2 | RECRUITING | 350 | — | — | May 14, 2025 | Dec 1, 2029 | Jun 8, 2026 | 56 | United States, Canada +4 |
| NCT06395948 | A Study Evaluating APG777 in Atopic Dermatitis | PHASE2 | ACTIVE NOT_RECRUITING | 470 | — | — | Apr 29, 2024 | Jun 1, 2028 | May 8, 2026 | 94 | United States, Canada +7 |
| NCT07027527 | An Active Comparator Safety Study Evaluating the Combination of APG777 + APG990 in Moderate-to-Severe Atopic Dermatitis | PHASE1 | ACTIVE NOT_RECRUITING | 86 | — | — | Jun 4, 2025 | Dec 1, 2027 | Jun 8, 2026 | 20 | Australia, Canada +1 |
| Arm | Type | Description |
|---|---|---|
| APG777 - Long Term Extension Treatment - 12 Weeks | EXPERIMENTAL | Participants who achieve EASI 75 or a vIGA-AD (0, 1) at the end of the Parent Study Treatment Period, and who did not use topical rescue medication during the Parent Study will maintain the same dose regimen (dose and frequency of injections) from the Maintenance Period of the Parent Study (APG777-201). |
| APG777 - Long Term Extension Treatment - 24 Weeks | EXPERIMENTAL | Participants who achieve EASI 75 or a vIGA-AD (0, 1) at the end of the Parent Study Treatment Period, and who did not use topical rescue medication during the Parent Study, will maintain the same dose regimen (dose and frequency of injections) from the Maintenance Period of the Parent Study (APG777-201). |
| APG777 - Open Label Escape Arm | EXPERIMENTAL | Participants who do not achieve EASI 75 or a vIGA-AD (0, 1) at the end of the Parent Study Treatment Period, or who used topical rescue medication during the Parent Study, will be assigned to the open-label Escape Arm and will receive APG777 per protocol defined dosing regimen. |
| Part A: Induction Period: APG777 | EXPERIMENTAL | Participants will receive APG777 per protocol defined dosing regimen |
| Part A: Induction Period: Placebo | PLACEBO_COMPARATOR | Participants will receive matching Placebo injections per protocol defined dosing regimen |
| Part A: Maintenance Period: APG777 | EXPERIMENTAL | Participants will receive 1 of 2 maintenance regimens of APG777 per protocol defined dosing regimen |
| Part B: Induction Period: APG777 | EXPERIMENTAL | Participants will receive APG777 in 1 of 3 regimens per protocol defined dosing regimen |
| Part B: Induction Period: Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo injections per protocol defined dosing regimen |
| Part B: Maintenance Period: APG777 | EXPERIMENTAL | Participants will receive APG777 per protocol defined dosing regimen |
| APG777 + APG990 | EXPERIMENTAL | Participants will receive protocol specified combination dose of APG777 + APG990 |
| Dupilumab | ACTIVE_COMPARATOR | Participants will receive protocol specified dose of Dupilumab |
| Name | Type | Description |
|---|---|---|
| APG777 | DRUG | APG777 subcutaneous injection |
| Placebo | DRUG | Matching placebo subcutaneous injection |
| APG990 | DRUG | SC injection |
| Dupilumab | DRUG | SC injection |
Inclusion Criteria: * Participants who have completed the Treatment Period in a prior APG777 study and were, in the Investigator's opinion, compliant with the study protocol * Participants who, in the Investigator's opinion, would benefit from long-term treatment with APG777 * Use the same non-pres...