NCT03468829

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2019

Shorter than P25 for phase_2

Geographic Reach
3 countries

5 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 19, 2018

Completed
11 months until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

March 11, 2019

Status Verified

March 1, 2019

Enrollment Period

1.2 years

First QC Date

March 7, 2018

Last Update Submit

March 8, 2019

Conditions

Respiratory Syncytial Virus Lower Respiratory Tract Infection

Outcome Measures

Primary Outcomes (1)

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

    From Day 1 to Day 7

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (3)

ALX-0171 Dose 1

EXPERIMENTAL
Biological: ALX-0171 Dose 1

ALX-0171 Dose 2

EXPERIMENTAL
Biological: ALX-0171 Dose 2

Placebo

PLACEBO COMPARATOR
Biological: Placebo

Interventions

ALX-0171 Dose 1BIOLOGICAL

Oral inhalation of ALX-0171 Dose 1 once daily for a maximum of 14 days

ALX-0171 Dose 1
ALX-0171 Dose 2BIOLOGICAL

Oral inhalation of ALX-0171 Dose 2 once daily for a maximum of 14 days

ALX-0171 Dose 2
PlaceboBIOLOGICAL

Oral inhalation of Placebo once daily for a maximum of 14 days

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Investigator site

Darlinghurst, Australia

Location

Investigator site

Westmead, Australia

Location

Investigator site

Leuven, Belgium

Location

Investigator site 1

Valencia, Spain

Location

Investigator site 2

Valencia, Spain

Location

Study Officials

  • Ablynx Clinical Department

    Ablynx, a Sanofi company

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2018

First Posted

March 19, 2018

Study Start

February 1, 2019

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

March 11, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

AU(2)ES(2)BE(1)