search
Back to results

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

Primary Purpose

Respiratory Syncytial Virus Lower Respiratory Tract Infection

Status
Withdrawn
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ALX-0171 Dose 1
ALX-0171 Dose 2
Placebo
Sponsored by
Ablynx, a Sanofi company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Syncytial Virus Lower Respiratory Tract Infection

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Investigator site
  • Investigator site
  • Investigator site
  • Investigator site 1
  • Investigator site 2

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

ALX-0171 Dose 1

ALX-0171 Dose 2

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Time-weighted average change from baseline in log10 RSV nasal viral load

Secondary Outcome Measures

Safety as measured by the incidence of treatment-emergent (serious) adverse events
Nasal RSV load parameter: time to undetectable shedding
Clinical stabilization (defined as respiratory rate <25/minute and stable oxygen saturation >92% on room air for at least 12 hours)
Number of days without oxygen or with oxygen supplementation
Progression to lower respiratory tract (LRT) disease in subjects presenting with upper respiratory tract infection (URTI) at baseline
Concentration of ALX-0171 in serum
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

Full Information

First Posted
March 7, 2018
Last Updated
March 8, 2019
Sponsor
Ablynx, a Sanofi company
search

1. Study Identification

Unique Protocol Identification Number
NCT03468829
Brief Title
Efficacy and Safety of ALX-0171 in Adult Hematopoietic Stem Cell Transplant (HSCT) Recipients Who Present With Respiratory Syncytial Virus (RSV) Infection
Official Title
A Randomized, Double-blind, Multicenter Study to Evaluate the Efficacy and Safety of ALX 0171 Versus Placebo, in Addition to Standard of Care, in Adults Who Have Undergone Hematopoietic Stem Cell Transplantation and Present With a Respiratory Syncytial Virus Respiratory Tract Infection
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Withdrawn
Why Stopped
ALX-0171 development program was stopped
Study Start Date
February 2019 (Anticipated)
Primary Completion Date
May 2020 (Anticipated)
Study Completion Date
May 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ablynx, a Sanofi company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Syncytial Virus Lower Respiratory Tract Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ALX-0171 Dose 1
Arm Type
Experimental
Arm Title
ALX-0171 Dose 2
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
ALX-0171 Dose 1
Intervention Description
Oral inhalation of ALX-0171 Dose 1 once daily for a maximum of 14 days
Intervention Type
Biological
Intervention Name(s)
ALX-0171 Dose 2
Intervention Description
Oral inhalation of ALX-0171 Dose 2 once daily for a maximum of 14 days
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Oral inhalation of Placebo once daily for a maximum of 14 days
Primary Outcome Measure Information:
Title
Time-weighted average change from baseline in log10 RSV nasal viral load
Time Frame
From Day 1 to Day 7
Secondary Outcome Measure Information:
Title
Safety as measured by the incidence of treatment-emergent (serious) adverse events
Time Frame
From Screening to Day 42
Title
Nasal RSV load parameter: time to undetectable shedding
Time Frame
From Day 1 to Day 42
Title
Clinical stabilization (defined as respiratory rate <25/minute and stable oxygen saturation >92% on room air for at least 12 hours)
Time Frame
From Day 1 to Day 42
Title
Number of days without oxygen or with oxygen supplementation
Time Frame
From Day 1 to Day 42
Title
Progression to lower respiratory tract (LRT) disease in subjects presenting with upper respiratory tract infection (URTI) at baseline
Time Frame
From Day 1 to Day 42
Title
Concentration of ALX-0171 in serum
Description
Measurement of ALX-0171 serum concentration at different time points from baseline until Day 14.
Time Frame
Day 1 to Day 14
Title
Immunogenicity as measured by the concentration of anti-ALX 0171 antibodies in serum
Time Frame
From Day 1 to Day 42

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject has received an HSCT using any conditioning regimen and for any underlying etiology (i.e., subject has received an autologous or allogeneic HSCT) Subject is clinically diagnosed with RSV infection with new onset or acute worsening Symptoms likely related to RSV infection have appeared within 5 days of screening and their severity requires initial or maintained hospitalization. Documented RSV infection in the upper respiratory tract (URT) 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: Subject has clinically significant bacteremia or fungemia within 7 days of screening Subject has clinically significant bacterial, fungal or viral pneumonia Subject presents evidence of shock requiring intensive care unit (ICU) monitoring and/or vasopressor treatment 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ablynx Clinical Department
Organizational Affiliation
Ablynx, a Sanofi company
Official's Role
Study Director
Facility Information:
Facility Name
Investigator site
City
Darlinghurst
Country
Australia
Facility Name
Investigator site
City
Westmead
Country
Australia
Facility Name
Investigator site
City
Leuven
Country
Belgium
Facility Name
Investigator site 1
City
Valencia
Country
Spain
Facility Name
Investigator site 2
City
Valencia
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs