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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02979431 | Dose Ranging Study of ALX-0171 in Infants Hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection | PHASE2 | COMPLETED | 180 | — | — | Jan 11, 2017 | May 25, 2018 | Oct 18, 2019 | 74 | Belgium, Bulgaria +15 |
The primary endpoint for this trial was the time needed for the viral load to drop below the quantification limit (time-to-BQL) of the plaque assay in nasal mid-turbinate swab specimens. Time-to-BQL was defined as the time from the first study drug administration to the first occurrence of a value below the quantification limit (BQL), provided the next measured value was also below the limit of quantification. The time to BQL for subjects with missing data and/or who did not reach BQL during the trial were censored at the last non-missing viral load assessment. The primary endpoint was analysed using logrank test to compare time-to-BQL between each of the ALX-0171 treatment groups and the combined placebo group. The tests were performed in a sequential way to preserve the family-wise error rate at 0.05. The comparisons were performed in the following order: ALX-0171 9 mg/kg vs Placebo, followed by ALX-0171 6mg/kg vs Placebo, ALX-0171 3mg/kg vs Placebo.
| Arm | Type | Description |
|---|---|---|
| ALX-0171 3.0 mg/kg | EXPERIMENTAL | Inhalation of ALX-0171 3.0 mg/kg once daily for 3 consecutive days |
| ALX-0171 6.0 mg/kg | EXPERIMENTAL | Inhalation of ALX-0171 6.0 mg/kg once daily for 3 consecutive days |
| ALX-0171 Dose 9.0mg/kg | EXPERIMENTAL | Inhalation of ALX-0171 9.0 mg/kg once daily for 3 consecutive days |
| Placebo | PLACEBO_COMPARATOR | Inhalation of Placebo once daily for 3 consecutive days |
| Name | Type | Description |
|---|---|---|
| ALX-0171 3.0 mg/kg | BIOLOGICAL | - |
| ALX-0171 6.0 mg/kg | BIOLOGICAL | - |
| ALX-0171 9.0 mg/kg | BIOLOGICAL | - |
| Placebo | OTHER | - |
Inclusion Criteria: 1. Male or female infant or young child aged 28 days to \< 2 years with gestational age ≥ 33 weeks at screening. 2. Subject weighed between ≥ 3.0 kg and \< 15.0 kg at screening. 3. Subject is otherwise healthy but was hospitalized for and clinically diagnosed with RSV LRTI (bron...