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

Respiratory Syncytial Virus Infection Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02309320
• Other study ID #: ALX0171-C104
• Secondary ID: 2014-002841-23
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 2014
• Est. completion date: February 2016

Study information

• Verified date: January 2019
• Source: Ablynx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 23 Months

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Respiratory Syncytial Virus Infection
• Respiratory Syncytial Virus Infections
• Respiratory Tract Infections
• Virus Diseases

Intervention

Biological:
• ALX-0171

Other:
• Placebo

Locations

Country	Name	City	State
Australia	Investigator Site 4	Brisbane
Australia	Investigator Site 2	Randwick
Australia	Investigator Site 3	Tasmania
Australia	Investigator Site 1	Westmead
Belgium	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
Bulgaria	Investigator Site 4	Kozloduy
Bulgaria	Investigator Site 1	Pleven
Bulgaria	Investigator Site 2	Ruse
Bulgaria	Investigator Site 3	Sevlievo
Estonia	Investigator Site	Tartu
Hungary	Investigator Site 1	Budapest
Hungary	Investigator Site 4	Budapest
Hungary	Investigator Site 5	Budapest
Hungary	Investigators Site 3	Budapest
Hungary	Investigator Site 2	Szeged
Israel	Investigator Site 3	Beer Sheva
Israel	Investigator Site 2	Haifa
Israel	Investigator Site 1	Petah-Tikva
Latvia	Investigator Site 3	Daugavpils
Latvia	Investigator Site 2	Riga
Latvia	Investigator Site 1	Valmiera
Malaysia	Investigator Site 2	Ipoh
Malaysia	Investigator Site 1	Kuala Lumpur
Malaysia	Investigator Site 3	Negeri Sembilan
Malaysia	Investigator Site 4	Pulau Pinang
Philippines	Investigator Site	Manila
Philippines	Investigator Site	Muntinlupa
Philippines	Investigator Site	Quezon City
Poland	Investigator Site 3	Bydgoszcz
Poland	Investigator Site 2	Lodz
Poland	Investigator Site 1	Trzebnica
Slovakia	Investigator Site 5	Banska Bystrica
Slovakia	Investigator Site 3	Bratislava
Slovakia	Investigator Site 2	Kosice
Slovakia	Investigator Site 6	Levice
Slovakia	Investigator Site 7	Liptovsky Mikulas
Slovakia	Investigator Site 1	Martin
Slovakia	Investigator Site 4	Poprad
Spain	Investigator Site 2	Barcelona
Spain	Investigator Site 5	Barcelona
Spain	Investigator Site 4	Girona
Spain	Investigator Site 3	Madrid
Spain	Investigator Site 7	Malaga
Spain	Investigator Site 6	Murcia
Spain	Investigator Site 1	Santiago de Compostela
Spain	Investigator Site 8	Sevilla
Thailand	Investigator Site 2	Chiang Mai
Thailand	Investigator Site	Khon Kaen
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
Ablynx

Countries where clinical trial is conducted

Australia,  Belgium,  Bulgaria,  Estonia,  Hungary,  Israel,  Latvia,  Malaysia,  Philippines,  Poland,  Slovakia,  Spain,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Exploratory Pharmacokinetics as measured by the concentration of ALX-0171 in serum		Day 3
Secondary	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
Secondary	Immunogenicity as measured by the concentration of anti-drug antibodies in serum		1 day before first dose to 14 days after first dose