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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02979431
Study type Interventional
Source Ablynx
Contact
Status Completed
Phase Phase 2
Start date January 11, 2017
Completion date May 25, 2018

See also
  Status Clinical Trial Phase
Terminated NCT03418571 - Evaluation of ALX-0171 in Japanese Children Hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection Phase 2
Withdrawn NCT03468829 - Efficacy and Safety of ALX-0171 in Adult Hematopoietic Stem Cell Transplant (HSCT) Recipients Who Present With Respiratory Syncytial Virus (RSV) Infection Phase 2