Respiratory Syncytial Virus Lower Respiratory Tract Infection
Conditions
Brief summary
The primary objective of the study is to evaluate the antiviral effect and safety of inhaled ALX-0171 in adults diagnosed with respiratory syncytial virus (RSV) respiratory tract infection after hematopoietic stem cell transplantation (HSCT). The secondary objective is to assess the clinical activity, pharmacokinetics (PK), virology, and immunogenicity of inhaled ALX 0171 in adults diagnosed with RSV respiratory tract infection after HSCT.
Interventions
BIOLOGICALALX-0171 Dose 1
Oral inhalation of ALX-0171 Dose 1 once daily for a maximum of 14 days
BIOLOGICALALX-0171 Dose 2
Oral inhalation of ALX-0171 Dose 2 once daily for a maximum of 14 days
BIOLOGICALPlacebo
Oral inhalation of Placebo once daily for a maximum of 14 days
Sponsors
Ablynx, a Sanofi company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Subject has received an HSCT using any conditioning regimen and for any underlying etiology (i.e., subject has received an autologous or allogeneic HSCT) 2. Subject is clinically diagnosed with RSV infection with new onset or acute worsening 3. Symptoms likely related to RSV infection have appeared within 5 days of screening and their severity requires initial or maintained hospitalization. 4. Documented RSV infection in the upper respiratory tract (URT) 5. Subject has: * Diagnosis of RSV lower respiratory tract (LRT) disease or * Diagnosis of RSV URT disease with high risk of progression to lower respiratory tract infection (LRTI) Others as defined in the protocol
Exclusion criteria
1. Subject has clinically significant bacteremia or fungemia within 7 days of screening 2. Subject has clinically significant bacterial, fungal or viral pneumonia 3. Subject presents evidence of shock requiring intensive care unit (ICU) monitoring and/or vasopressor treatment 4. Subject requires or is expected to require invasive mechanical ventilation or intensive non-invasive respiratory support. Standard oxygen supplementation up to 6 L/minute is permitted provided it can be interrupted for the duration of study drug administration. Others as defined in the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time-weighted average change from baseline in log10 RSV nasal viral load | From Day 1 to Day 7 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nasal RSV load parameter: time to undetectable shedding | From Day 1 to Day 42 | — |
| Clinical stabilization (defined as respiratory rate <25/minute and stable oxygen saturation >92% on room air for at least 12 hours) | From Day 1 to Day 42 | — |
| Number of days without oxygen or with oxygen supplementation | From Day 1 to Day 42 | — |
| Safety as measured by the incidence of treatment-emergent (serious) adverse events | From Screening to Day 42 | — |
| Concentration of ALX-0171 in serum | Day 1 to Day 14 | Measurement of ALX-0171 serum concentration at different time points from baseline until Day 14. |
| Immunogenicity as measured by the concentration of anti-ALX 0171 antibodies in serum | From Day 1 to Day 42 | — |
| Progression to lower respiratory tract (LRT) disease in subjects presenting with upper respiratory tract infection (URTI) at baseline | From Day 1 to Day 42 | — |
Countries
Australia, Belgium, Spain
Outcome results
None listed