Efficacy and Safety of ALX-0171 in Adult Hematopoietic Stem Cell Transplant (HSCT) Recipients Who Present With Respiratory Syncytial Virus (RSV) Infection

Phase 2

Withdrawn

• Conditions: Respiratory Syncytial Virus Lower Respiratory Tract Infection
• Interventions: Biological: ALX-0171 Dose 1; Biological: Placebo; Biological: ALX-0171 Dose 2

• Registration Number: NCT03468829
• Lead Sponsor: Ablynx, a Sanofi company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-07
• Study First Submitted QC: 2018-03-12
• Study First Posted: 2018-03-19
• Study Start: 2019-02
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-08
• Last Update Posted: 2019-03-11
• Primary Completion: 2020-05
• Study Completion: 2020-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ALX-0171 Dose 1	ALX-0171 Dose 1	-
Placebo	Placebo	-
ALX-0171 Dose 2	ALX-0171 Dose 2	-

Primary Outcome Measures

Name	Time	Method
Time-weighted average change from baseline in log10 RSV nasal viral load	From Day 1 to Day 7

Secondary Outcome Measures

Name	Time	Method
Number of days without oxygen or with oxygen supplementation	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
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.
Nasal RSV load parameter: time to undetectable shedding	From Day 1 to Day 42
Immunogenicity as measured by the concentration of anti-ALX 0171 antibodies in serum	From Day 1 to Day 42
Safety as measured by the incidence of treatment-emergent (serious) adverse events	From Screening 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

Trial Locations

Locations (3)

Investigator site 1; 🇪🇸 Valencia, Spain

Investigator site; 🇧🇪 Leuven, Belgium

Investigator site 2; 🇪🇸 Valencia, Spain