NCT03418571

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

A Randomized, Double-blind, Multicenter, Multiple-dose Study of ALX-0171 Versus Placebo Along With Standard of Care in Japanese Infants and Young Children Hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Ablynx, a Sanofi company · Industry
• Sex: All
• Age: 28 Days – 2 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Four dose levels were planned to be evaluated in four consecutive cohorts consisting of Japanese infants and young children aged 28 days to \<2 years with a gestational age ≥33 weeks who were hospitalized for and diagnosed with respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI): * Dose level 1: target dose of 1.5 mg/kg * Dose level 2: target dose of 3.0 mg/kg * Dose level 3: target dose of 6.0 mg/kg * Dose level 4: target dose of 9.0 mg/kg Each cohort was planned to consist of 15 subjects enrolled and randomly assigned to receive ALX-0171 or placebo, in an allocation ratio of 4:1 (N = 12 active versus N = 3 placebo per cohort). Due to early termination of the trial, only enrollment of Cohort 1 could be completed as planned. For Cohort 2, only 1 subject was screened but did not meet the eligibility criteria and was considered a screen failure. Therefore, data were not available for treatment groups ALX-0171 3.0 mg/kg, 6.0 mg/kg, and 9.0 mg/kg. Of note, in line with applicable guidelines, an Independent Data Monitoring Committee (IDMC) was assigned to monitor the study. Upon completing of Cohort 1, the IDMC reviewed the available unblinded safety data and unanimously recommended to continue the study with no changes to the protocol.

Conditions

• Respiratory Syncytial Virus Lower Respiratory Tract Infection

Interventions

Type	Name	Description
BIOLOGICAL	ALX-0171 1.5 mg/kg	ALX-0171 1.5 mg/kg was administered via a single inhalation once daily for 3 consecutive days.
OTHER	Placebo	Placebo was administered via a single inhalation once daily for 3 consecutive days.

Timeline

• Start date: 2018-03-01
• Primary completion: 2018-10-24
• Completion: 2018-10-24
• First posted: 2018-02-01
• Last updated: 2019-07-30
• Results posted: 2019-07-15

Locations

25 sites across 1 country: Japan