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A Multicentre Study in Otherwise Healthy Infants and Toddlers Hospitalised For and Diagnosed With RSV Lower Respiratory Tract Infection to Evaluate the Safety, Tolerability, and Clinical Activity of ALX-0171

Primary Purpose

Respiratory Syncytial Virus Infection

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ALX-0171
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 Infection

Eligibility Criteria

28 Days - 23 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subject is otherwise healthy, but hospitalised for and clinically diagnosed with RSV LRTI (Lower Respiratory Tract Infection)
  2. Subject has appearance of upper or lower respiratory tract infection symptoms that are likely related to RSV
  3. Subject has a positive RSV diagnostic test
  4. Others as defined in the protocol

Exclusion Criteria:

  1. Subject has history of wheezing
  2. Subject is known to have significant comorbidities
  3. Subject is known to be immunocompromised
  4. Subject is suspected of having a clinically relevant infection other than RSV
  5. Others as defined in the protocol

Sites / Locations

  • Investigator Site 4
  • Investigator Site 2
  • Investigator Site 3
  • Investigator Site 1
  • Investigator Site 1
  • Investigator Site 6
  • Investigator Site 4
  • Investigator Site 5
  • Investigator Site 2
  • Investigator Site 3
  • Investigator Site 4
  • Investigator Site 1
  • Investigator Site 2
  • Investigator Site 3
  • Investigator Site
  • Investigator Site 1
  • Investigators Site 3
  • Investigator Site 4
  • Investigator Site 5
  • Investigator Site 2
  • Investigator Site 3
  • Investigator Site 2
  • Investigator Site 1
  • Investigator Site 3
  • Investigator Site 2
  • Investigator Site 1
  • Investigator Site 2
  • Investigator Site 1
  • Investigator Site 3
  • Investigator Site 4
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site 3
  • Investigator Site 2
  • Investigator Site 1
  • Investigator Site 5
  • Investigator Site 3
  • Investigator Site 2
  • Investigator Site 6
  • Investigator Site 7
  • Investigator Site 1
  • Investigator Site 4
  • Investigator Site 5
  • Investigator Site 2
  • Investigator Site 4
  • Investigator Site 3
  • Investigator Site 7
  • Investigator Site 6
  • Investigator Site 1
  • Investigator Site 8
  • Investigator Site 2
  • Investigator Site
  • Investigator Site 2
  • Investigator Site 4
  • Investigator Site 5
  • Investigator Site 6
  • Investigator Site 1
  • Investigator Site 3

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ALX-0171

Placebo

Arm Description

Inhalation of ALX-0171 during 3 consecutive days

Inhalation of Placebo during 3 consecutive days

Outcomes

Primary Outcome Measures

Safety and Tolerability as measured by the incidence of treatment emergent adverse events, clinical laboratory parameters and physical examination

Secondary Outcome Measures

Clinical activity as measured by the evaluation of the clinical response of the subjects
Exploratory Pharmacokinetics as measured by the concentration of ALX-0171 in serum
Exploratory Pharmacodynamics as measured by the concentration of viral load in respiratory secretions and exploratory biomarkers in serum
Immunogenicity as measured by the concentration of anti-drug antibodies in serum

Full Information

First Posted
November 27, 2014
Last Updated
January 9, 2019
Sponsor
Ablynx, a Sanofi company
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1. Study Identification

Unique Protocol Identification Number
NCT02309320
Brief Title
A Multicentre Study in Otherwise Healthy Infants and Toddlers Hospitalised For and Diagnosed With RSV Lower Respiratory Tract Infection to Evaluate the Safety, Tolerability, and Clinical Activity of ALX-0171
Official Title
A Phase I/IIa Multicentre Study in Otherwise Healthy Infants and Toddlers Hospitalised For and Diagnosed With Respiratory Syncytial Virus Lower Respiratory Tract Infection, Consisting of an Open-label Lead-in Part Followed by a Double-blind, Placebo-controlled Part, to Evaluate the Safety, Tolerability and Clinical Activity of ALX-0171, Administered Via Inhalation, in Addition to Standard of Care.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
December 2014 (Actual)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of the study is to investigate the safety and tolerability of ALX-0171. The secondary objectives are to evaluate the clinical effect of ALX-0171 and to explore the pharmacodynamics (PD) and the systemic pharmacokinetics (PK) of ALX-0171.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ALX-0171
Arm Type
Experimental
Arm Description
Inhalation of ALX-0171 during 3 consecutive days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Inhalation of Placebo during 3 consecutive days
Intervention Type
Biological
Intervention Name(s)
ALX-0171
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Safety and Tolerability as measured by the incidence of treatment emergent adverse events, clinical laboratory parameters and physical examination
Time Frame
1 day before first dose to 14 days after first dose
Secondary Outcome Measure Information:
Title
Clinical activity as measured by the evaluation of the clinical response of the subjects
Time Frame
1 day before first dose to 14 days after first dose
Title
Exploratory Pharmacokinetics as measured by the concentration of ALX-0171 in serum
Time Frame
Day 3
Title
Exploratory Pharmacodynamics as measured by the concentration of viral load in respiratory secretions and exploratory biomarkers in serum
Time Frame
1 day before first dose to 14 days after first dose
Title
Immunogenicity as measured by the concentration of anti-drug antibodies in serum
Time Frame
1 day before first dose to 14 days after first dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
28 Days
Maximum Age & Unit of Time
23 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is otherwise healthy, but hospitalised for and clinically diagnosed with RSV LRTI (Lower Respiratory Tract Infection) Subject has appearance of upper or lower respiratory tract infection symptoms that are likely related to RSV Subject has a positive RSV diagnostic test Others as defined in the protocol Exclusion Criteria: Subject has history of wheezing Subject is known to have significant comorbidities Subject is known to be immunocompromised Subject is suspected of having a clinically relevant infection other than RSV 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 4
City
Brisbane
Country
Australia
Facility Name
Investigator Site 2
City
Randwick
ZIP/Postal Code
2031
Country
Australia
Facility Name
Investigator Site 3
City
Tasmania
Country
Australia
Facility Name
Investigator Site 1
City
Westmead
ZIP/Postal Code
2145
Country
Australia
Facility Name
Investigator Site 1
City
Antwerp
Country
Belgium
Facility Name
Investigator Site 6
City
Antwerp
Country
Belgium
Facility Name
Investigator Site 4
City
Brussels
Country
Belgium
Facility Name
Investigator Site 5
City
Brussels
Country
Belgium
Facility Name
Investigator Site 2
City
Ghent
Country
Belgium
Facility Name
Investigator Site 3
City
Leuven
Country
Belgium
Facility Name
Investigator Site 4
City
Kozloduy
Country
Bulgaria
Facility Name
Investigator Site 1
City
Pleven
Country
Bulgaria
Facility Name
Investigator Site 2
City
Ruse
Country
Bulgaria
Facility Name
Investigator Site 3
City
Sevlievo
Country
Bulgaria
Facility Name
Investigator Site
City
Tartu
Country
Estonia
Facility Name
Investigator Site 1
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Investigators Site 3
City
Budapest
ZIP/Postal Code
1089
Country
Hungary
Facility Name
Investigator Site 4
City
Budapest
Country
Hungary
Facility Name
Investigator Site 5
City
Budapest
Country
Hungary
Facility Name
Investigator Site 2
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Investigator Site 3
City
Beer Sheva
Country
Israel
Facility Name
Investigator Site 2
City
Haifa
Country
Israel
Facility Name
Investigator Site 1
City
Petah-Tikva
Country
Israel
Facility Name
Investigator Site 3
City
Daugavpils
Country
Latvia
Facility Name
Investigator Site 2
City
Riga
Country
Latvia
Facility Name
Investigator Site 1
City
Valmiera
Country
Latvia
Facility Name
Investigator Site 2
City
Ipoh
Country
Malaysia
Facility Name
Investigator Site 1
City
Kuala Lumpur
Country
Malaysia
Facility Name
Investigator Site 3
City
Negeri Sembilan
Country
Malaysia
Facility Name
Investigator Site 4
City
Pulau Pinang
Country
Malaysia
Facility Name
Investigator Site
City
Manila
Country
Philippines
Facility Name
Investigator Site
City
Muntinlupa
Country
Philippines
Facility Name
Investigator Site
City
Quezon City
Country
Philippines
Facility Name
Investigator Site 3
City
Bydgoszcz
Country
Poland
Facility Name
Investigator Site 2
City
Lodz
Country
Poland
Facility Name
Investigator Site 1
City
Trzebnica
Country
Poland
Facility Name
Investigator Site 5
City
Banska Bystrica
ZIP/Postal Code
97409
Country
Slovakia
Facility Name
Investigator Site 3
City
Bratislava
ZIP/Postal Code
82556
Country
Slovakia
Facility Name
Investigator Site 2
City
Kosice
ZIP/Postal Code
04011
Country
Slovakia
Facility Name
Investigator Site 6
City
Levice
Country
Slovakia
Facility Name
Investigator Site 7
City
Liptovsky Mikulas
Country
Slovakia
Facility Name
Investigator Site 1
City
Martin
ZIP/Postal Code
03659
Country
Slovakia
Facility Name
Investigator Site 4
City
Poprad
ZIP/Postal Code
05845
Country
Slovakia
Facility Name
Investigator Site 5
City
Barcelona
ZIP/Postal Code
08009
Country
Spain
Facility Name
Investigator Site 2
City
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Investigator Site 4
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Investigator Site 3
City
Madrid
ZIP/Postal Code
28922
Country
Spain
Facility Name
Investigator Site 7
City
Malaga
Country
Spain
Facility Name
Investigator Site 6
City
Murcia
Country
Spain
Facility Name
Investigator Site 1
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Investigator Site 8
City
Sevilla
Country
Spain
Facility Name
Investigator Site 2
City
Chiang Mai
Country
Thailand
Facility Name
Investigator Site
City
Khon Kaen
Country
Thailand
Facility Name
Investigator Site 2
City
City Of Edinburgh
Country
United Kingdom
Facility Name
Investigator Site 4
City
Kent
Country
United Kingdom
Facility Name
Investigator Site 5
City
Liverpool
Country
United Kingdom
Facility Name
Investigator Site 6
City
Nottingham
Country
United Kingdom
Facility Name
Investigator Site 1
City
Oxford
Country
United Kingdom
Facility Name
Investigator Site 3
City
Tooting
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

A Multicentre Study in Otherwise Healthy Infants and Toddlers Hospitalised For and Diagnosed With RSV Lower Respiratory Tract Infection to Evaluate the Safety, Tolerability, and Clinical Activity of ALX-0171

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