drugset / Trial / NCT03418571

Evaluation of ALX-0171 in Japanese Children Hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection

NCT03418571 ↗

Phase 2 Terminated 15 enrolled Ablynx, a Sanofi company
RandomizedSequentialQuadruple-blindTreatment

Summary

This was a randomized, double-blind, multicenter, Phase II study (NCT03418571) designed to support the selection of an optimal dose of inhaled ALX-0171 for further clinical development, taking ethnicity into consideration. Based on the results of the Phase IIb dose-ranging study ALX0171-C201 (RESPIRE), the Sponsor decided to discontinue ALX-0171 development in infants and to early terminate the ALX0171-C203 study.

Timeline

Start
2018-03-01
Primary completion
2018-10-24
Completion
2018-10-24

Outcome

Outcome not reported

Stopped: “The Sponsor decided to discontinue ALX-0171 development (due to insufficient evidence of efficacy). As a result, the ALX0171-C203 study was early terminated.”

Drugs

EvaluationDrugModalityDoseRoute
Subject ALX-0171 Protein / enzyme biologic 1.5 mg/kg Inhaled