Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ALX-0171/kg · 1 trial · 1 indication
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...
ALX-0171 is an investigational monoclonal antibody being developed for respiratory syncytial virus (RSV) infection, including RSV lower respiratory tract infection. It has been studied in healthy volunteers and in infants and toddlers hospitalized with RSV lower respiratory tract infection.
ALX-0171 is a monoclonal antibody designed to target respiratory syncytial virus (RSV). It is being developed as a potential treatment for RSV infection and RSV lower respiratory tract infection.
ALX-0171 is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker SNY.
ALX-0171 has completed Phase 1 and Phase 2 clinical trials. It remains an investigational drug and is not approved by regulatory authorities. All listed trials for ALX-0171 have been completed.
ALX-0171 has been studied in several completed trials, including NCT01483911 in healthy male volunteers, NCT01909843 in adults with hyperresponsive airways, NCT02309320 in infants and toddlers with RSV lower respiratory tract infection, and NCT02979431, a dose-ranging study in hospitalized infants.
ALX-0171 is a distinct investigational monoclonal antibody targeting respiratory syncytial virus (RSV). It is not the same as other approved RSV treatments, as it remains in clinical development and has not received regulatory approval.