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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07393373 | Open-Label, Long-Term, Extension Study of Infigratinib in Children With Hypochondroplasia | PHASE2 | ENROLLING BY_INVITATION | 135 | — | — | Apr 23, 2026 | May 31, 2036 | May 26, 2026 | 24 | United States, Australia +8 |
| NCT06873035 | An Interventional Study of Infigratinib in Children With Hypochondroplasia | PHASE2 | ENROLLING BY_INVITATION | 24 | — | — | Apr 22, 2025 | Jan 1, 2027 | Dec 15, 2025 | 22 | United States, Australia +8 |
| Arm | Type | Description |
|---|---|---|
| Arm 1: Rollover subjects | EXPERIMENTAL | Children who have completed QED-sponsored interventional study with infigratinib |
| Phase 2 Cohort 1 | EXPERIMENTAL | infigratinib (0.128 mg/kg/day) |
| Phase 2 Cohort 2 | EXPERIMENTAL | infigratinib (0.25 mg/kg/day) |
| Name | Type | Description |
|---|---|---|
| Infigratinib | DRUG | Infigratinib to be administered by mouth and initiated at the last dose level received in the ACCEL 2/3 study or at the dose selected to be further evaluated after proof-of-concept is established for Phase 2 portion of ACCEL 2/3. |
| infigratinib 0.128 mg/kg/day | DRUG | Oral infigratinib 0.128 mg/kg/day |
| infigratinib 0.25 mg/kg/day | DRUG | Oral infigratinib 0.25 mg/kg/day |
Inclusion Criteria: * Inclusion Criteria for Participants Rolling Over from ACCEL 2/3 1. Pediatric participants with HCH who have completed ACCEL 2/3 2. Negative pregnancy test in girls ≥10 years of age or girls of any age who have experienced menarche Exclusion Criteria: * Exclusion Criteri...