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
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.
2 other identifiers
interventional
53
13 countries
58
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Dec 2014
58 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2014
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedFirst Posted
Study publicly available on registry
December 5, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedJanuary 10, 2019
January 1, 2019
1.2 years
November 27, 2014
January 9, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Safety and Tolerability as measured by the incidence of treatment emergent adverse events, clinical laboratory parameters and physical examination
1 day before first dose to 14 days after first dose
Secondary Outcomes (4)
Clinical activity as measured by the evaluation of the clinical response of the subjects
1 day before first dose to 14 days after first dose
Exploratory Pharmacokinetics as measured by the concentration of ALX-0171 in serum
Day 3
Exploratory Pharmacodynamics as measured by the concentration of viral load in respiratory secretions and exploratory biomarkers in serum
1 day before first dose to 14 days after first dose
Immunogenicity as measured by the concentration of anti-drug antibodies in serum
1 day before first dose to 14 days after first dose
Study Arms (2)
ALX-0171
EXPERIMENTALInhalation of ALX-0171 during 3 consecutive days
Placebo
PLACEBO COMPARATORInhalation of Placebo during 3 consecutive days
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (59)
Investigator Site 4
Brisbane, Australia
Investigator Site 2
Randwick, 2031, Australia
Investigator Site 3
Tasmania, Australia
Investigator Site 1
Westmead, 2145, Australia
Investigator Site 1
Antwerp, Belgium
Investigator Site 6
Antwerp, Belgium
Investigator Site 4
Brussels, Belgium
Investigator Site 5
Brussels, Belgium
Investigator Site 2
Ghent, Belgium
Investigator Site 3
Leuven, Belgium
Investigator Site 4
Kozloduy, Bulgaria
Investigator Site 1
Pleven, Bulgaria
Investigator Site 2
Rousse, Bulgaria
Investigator Site 3
Sevlievo, Bulgaria
Investigator Site
Tartu, Estonia
Investigator Site 1
Budapest, 1083, Hungary
Investigators Site 3
Budapest, 1089, Hungary
Investigator Site 4
Budapest, Hungary
Investigator Site 5
Budapest, Hungary
Investigator Site 2
Szeged, 6720, Hungary
Investigator Site 3
Beersheba, Israel
Investigator Site 2
Haifa, Israel
Investigator Site 1
Petah Tikva, Israel
Investigator Site 3
Daugavpils, Latvia
Investigator Site 2
Riga, Latvia
Investigator Site 1
Valmiera, Latvia
Investigator Site 2
Ipoh, Malaysia
Investigator Site 1
Kuala Lumpur, Malaysia
Investigator Site 3
Negeri Sembilan, Malaysia
Investigator Site 4
Pulau Pinang, Malaysia
Investigator Site
City of Muntinlupa, Philippines
Investigator Site
Manila, Philippines
Investigator Site
Quezon City, Philippines
Investigator Site 3
Bydgoszcz, Poland
Investigator Site 2
Lodz, Poland
Investigator Site 1
Trzebnica, Poland
Investigator Site 5
Banská Bystrica, 97409, Slovakia
Investigator Site 3
Bratislava, 82556, Slovakia
Investigator Site 2
Košice, 04011, Slovakia
Investigator Site 6
Levice, Slovakia
Investigator Site 7
Liptovský Mikuláš, Slovakia
Investigator Site 1
Martin, 03659, Slovakia
Investigator Site 4
Poprad, 05845, Slovakia
Investigator Site 5
Barcelona, 08009, Spain
Investigator Site 2
Barcelona, 08208, Spain
Investigator Site 4
Girona, 17007, Spain
Investigator Site 3
Madrid, 28922, Spain
Investigator Site 7
Málaga, Spain
Investigator Site 6
Murcia, Spain
Investigator Site 1
Santiago de Compostela, 15706, Spain
Investigator Site 8
Seville, Spain
Investigator Site 2
Chiang Mai, Thailand
Investigator Site
Khon Kaen, Thailand
Investigator Site 2
City of Edinburgh, United Kingdom
Investigator Site 4
Kent, United Kingdom
Investigator Site 5
Liverpool, United Kingdom
Investigator Site 6
Nottingham, United Kingdom
Investigator Site 1
Oxford, United Kingdom
Investigator Site 3
Tooting, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ablynx Clinical Department
Ablynx, a Sanofi company
Study Design
- Study Type
- interventional
- Phase
- phase 1
- 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
November 27, 2014
First Posted
December 5, 2014
Study Start
December 1, 2014
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
January 10, 2019
Record last verified: 2019-01