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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07220811 | Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy | PHASE2 | RECRUITING | 100 | — | — | Oct 22, 2025 | Jan 1, 2028 | Jun 5, 2026 | 31 | United States, Australia +1 |
Proportion of participants who consumed a single dose of ≥600 mg (ie, a cumulative dose of ≥1044 mg) of peanut or cashew protein, or a single dose of ≥1000 mg (ie, a cumulative dose of ≥2044 mg) of milk, egg, or walnut protein without dose-limiting symptoms at Part 1 DBPCFC
| Arm | Type | Description |
|---|---|---|
| RPT904 (Q8W) | EXPERIMENTAL | RPT904 every 8 weeks. The dose levels of RPT904 (150 mg, 300 mg, and 600 mg) within the Q8W cohort will be assigned based on participant weight and baseline total IgE level. RPT904 subcutaneous injection every 8 weeks with a loading dose at Week 2 (Part 1: 24 weeks; Part 2: 24 weeks); matching placebo at intervening visits to maintain blinding. |
| RPT904 (Q12W) | EXPERIMENTAL | RPT904 every 12 weeks. The dose levels of RPT904 (150 mg, 300 mg, and 600 mg) will be assigned based on participant weight and baseline total IgE level. RPT904 subcutaneous injection every 12 weeks with a loading dose at Week 2 (Part 1: 24 weeks; Part 2: 24 weeks); matching placebo at intervening visits to maintain blinding. |
| Placebo | PLACEBO_COMPARATOR | Placebo subcutaneous injection on schedules matching both the Q8W and Q12W arms in Part 1 (24 weeks); RPT904 every 8 or 12 weeks with a loading dose at Week 26 on schedules matching both the Q8W and Q12W arms Part 2 (24 weeks), with matching placebo at intervening visits to maintain blinding. |
| Name | Type | Description |
|---|---|---|
| RPT904 | DRUG | Subcutaneous injection once every 8 weeks |
| Placebo | OTHER | Subcutaneous injection at the intervening dosing visits |
Key Inclusion Criteria: * Participant and/or parent/legal guardian must be able to understand and provide informed consent and/or assent, as applicable. * Male or female, 12 to less than 56 years of age at screening. * Allergic to at least 1 of the following foods: peanut, milk, egg, cashew, or wal...