NCT02979431

Dose Ranging Study of ALX-0171 in Infants Hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection

A Randomized, Double-blind, Placebo-controlled, Multicenter Dose Ranging Study of ALX-0171 in Infants and Young Children Hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Ablynx, a Sanofi company · Industry
• Sex: All
• Age: 28 Days – 2 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to evaluate the anti-viral effect and safety of different doses of inhaled ALX-0171 in subjects hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection (RSV LRTI). The secondary objective is to evaluate the clinical activity, pharmacokinetic (PK) properties, pharmacodynamic (PD) effect and immunogenicity of different doses of inhaled ALX-0171.

Detailed description

This was a Phase 2b, randomized, double-blind, placebo-controlled, international, multicenter dose-ranging study in infants and toddlers hospitalized for RSV LRTI. The study evaluated 3 dose levels of ALX-0171 in a sequential part (safety Cohorts 1-3) followed by a parallel part (Cohort 4). An Independent Data Monitoring Committee (IDMC) was assigned to review study data and provide recommendations on proceeding to the next safety cohort and on which dose levels could be taken forward in the parallel part. Three dose levels of ALX-0171 were evaluated: * Dose 1: target dose of 3.0 mg/kg * Dose 2: target dose of 6.0 mg/kg * Dose 3: target dose of 9.0 mg/kg The study drug was administered by inhalation once daily for 3 consecutive days along with standard of care treatment, which was determined by the Investigator (or his/her designee) according to institutional practice.

Conditions

• Respiratory Syncytial Virus Lower Respiratory Tract Infection

Interventions

Type	Name	Description
BIOLOGICAL	ALX-0171 3.0 mg/kg
BIOLOGICAL	ALX-0171 6.0 mg/kg
BIOLOGICAL	ALX-0171 9.0 mg/kg
OTHER	Placebo

Timeline

• Start date: 2017-01-11
• Primary completion: 2018-05-25
• Completion: 2018-05-25
• First posted: 2016-12-01
• Last updated: 2019-10-18
• Results posted: 2019-10-18

Locations

74 sites across 17 countries: Belgium, Bulgaria, Chile, Colombia, Croatia, Czechia, Estonia, Germany, Hungary, Israel, Latvia, Malaysia, Philippines, Poland, Slovakia, Spain, Thailand