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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Respiratory Syncytial Virus Lower Respiratory Tract Infection
• Intervention / Treatment: Biological: ALX-0171 Dose 1; Biological: ALX-0171 Dose 2; Biological: Placebo

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Darlinghurst, Australia
    • Investigator site
  • Westmead, Australia
    • Investigator site
• Belgium
  • Leuven, Belgium
    • Investigator site
• Spain
  • Valencia, Spain
    • Investigator Site 1
  • Valencia, Spain
    • Investigator Site 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Biological: Placebo; Oral inhalation of Placebo once daily for a maximum of 14 days
Experimental: ALX-0171 Dose 1	Biological: ALX-0171 Dose 1; Oral inhalation of ALX-0171 Dose 1 once daily for a maximum of 14 days
Experimental: ALX-0171 Dose 2	Biological: ALX-0171 Dose 2; Oral inhalation of ALX-0171 Dose 2 once daily for a maximum of 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time-weighted average change from baseline in log10 RSV nasal viral load	From Day 1 to Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety as measured by the incidence of treatment-emergent (serious) adverse events		From Screening to Day 42
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
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	Measurement of ALX-0171 serum concentration at different time points from baseline until Day 14.	Day 1 to Day 14
Immunogenicity as measured by the concentration of anti-ALX 0171 antibodies in serum		From Day 1 to Day 42

Collaborators and Investigators

• Sponsor: Ablynx

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2019
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: March 7, 2018
• First Submitted That Met QC Criteria: March 12, 2018
• First Posted (Actual): March 19, 2018

Study Record Updates

• Last Update Posted (Actual): March 11, 2019
• Last Update Submitted That Met QC Criteria: March 8, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Infections; Communicable Diseases; Respiratory Tract Infections; Anti-Infective Agents; Antiviral Agents; Gontivimab
• Other Study ID Numbers: ALX0171-C204; 2017-003356-23 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No