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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04812925 | A Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia | PHASE3 | ACTIVE NOT_RECRUITING | 173 | — | — | Nov 17, 2021 | Oct 1, 2026 | Jan 12, 2026 | 83 | United States, Argentina +23 |
| NCT04687072 | A Study to Evaluate the Efficacy and Safety of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia | PHASE3 | COMPLETED | 207 | — | — | Dec 16, 2020 | Oct 9, 2023 | Oct 31, 2024 | 200 | United States, Argentina +30 |
A participant was considered a responder for this endpoint (i.e., had a sustained platelet count response) if the participant had platelet counts of ≥50 × 10\^9/L for ≥4 of the 6 analysis visits between Weeks 19 and 24.
| Arm | Type | Description |
|---|---|---|
| efgartigimod PH20 SC | EXPERIMENTAL | Patients receiving efgartigimod PH20 SC treatment |
| Placebo PH20 SC | PLACEBO_COMPARATOR | Patients receiving placebo PH20 SC treatment |
| Name | Type | Description |
|---|---|---|
| efgartigimod PH20 SC | BIOLOGICAL | Subcutaneous injection with efgartigimod PH20 SC |
| Placebo PH20 SC | OTHER | Subcutaneous injection with placebo PH20 SC |
Inclusion Criteria: 1. Ability to understand the requirements of the trial and provide written informed consent (including consent for the use and disclosure of research-related health information), willing and able to comply with the trial protocol procedures (including attending the required tria...