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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07455006 | Safety and Efficacy Study of QL0911 to Treat Immune Thrombocytopenia (ITP) in Pediatric Patients | PHASE3 | NOT YET_RECRUITING | 60 | — | — | Apr 20, 2026 | Mar 10, 2028 | Mar 6, 2026 | - | — |
A participant with durable platelet response was defined as achieving at least 6 weekly platelet counts of ≥ 50 x 10\^9/L from week 18 to week 25. If a platelet count from a participant was not available (missing) in a certain week, that week was imputed as non-response for that participant. Platelet counts were not deemed as a positive response for 4 weeks after the administration of rescue medication.
| Arm | Type | Description |
|---|---|---|
| QL0911 | EXPERIMENTAL | Participants received once weekly subcutaneous QL0911 at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10\^9/L. |
| placebo | PLACEBO_COMPARATOR | Participants received weekly subcutaneous placebo. |
| Name | Type | Description |
|---|---|---|
| QL0911 | DRUG | The starting dose of QL0911 is 1 µg/kg administered weekly by subcutaneous injection. Participants will return to the clinic weekly to provide platelet counts and undergo dose titrations under the supervision of the treating physician. Weekly dose increases will continue in increments of 1 µg/kg up to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10\^9/L. Dose adjustment will be allowed during the treatment period to maintain a platelet count between ≥ 50 x 10\^9/L and ≤ 200 x 10\^9/L. |
| Placebo | DRUG | Matching placebo administered by subcutaneous injection. |
Inclusion Criteria: 1. Age ≥ 1 years old and \< 18 years old. 2. Diagnosed primary ITP for at least 12 months; 3. Had received at least one first-line ITP treatment with no response or recurrence after treatment; 4. Had a platelet count \<30×10\^9/L within 48 hours before the first dose; 5. Eastern...