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

January 9, 2019 updated by: Ablynx

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Brisbane, Australia
        • Investigator Site 4
      • Randwick, Australia, 2031
        • Investigator Site 2
      • Tasmania, Australia
        • Investigator Site 3
      • Westmead, Australia, 2145
        • Investigator Site 1
  • Belgium
      • Antwerp, Belgium
        • Investigator Site 1
      • Antwerp, Belgium
        • Investigator Site 6
      • Brussels, Belgium
        • Investigator Site 4
      • Brussels, Belgium
        • Investigator Site 5
      • Ghent, Belgium
        • Investigator Site 2
      • Leuven, Belgium
        • Investigator Site 3
  • Bulgaria
      • Kozloduy, Bulgaria
        • Investigator Site 4
      • Pleven, Bulgaria
        • Investigator Site 1
      • Ruse, Bulgaria
        • Investigator Site 2
      • Sevlievo, Bulgaria
        • Investigator Site 3
  • Estonia
      • Tartu, Estonia
        • Investigator site
  • Hungary
      • Budapest, Hungary, 1083
        • Investigator Site 1
      • Budapest, Hungary, 1089
        • Investigators Site 3
      • Budapest, Hungary
        • Investigator Site 4
      • Budapest, Hungary
        • Investigator Site 5
      • Szeged, Hungary, 6720
        • Investigator Site 2
  • Israel
      • Beer Sheva, Israel
        • Investigator Site 3
      • Haifa, Israel
        • Investigator Site 2
      • Petah-Tikva, Israel
        • Investigator Site 1
  • Latvia
      • Daugavpils, Latvia
        • Investigator Site 3
      • Riga, Latvia
        • Investigator Site 2
      • Valmiera, Latvia
        • Investigator Site 1
  • Malaysia
      • Ipoh, Malaysia
        • Investigator Site 2
      • Kuala Lumpur, Malaysia
        • Investigator Site 1
      • Negeri Sembilan, Malaysia
        • Investigator Site 3
      • Pulau Pinang, Malaysia
        • Investigator Site 4
  • Philippines
      • Manila, Philippines
        • Investigator site
      • Muntinlupa, Philippines
        • Investigator site
      • Quezon City, Philippines
        • Investigator site
  • Poland
      • Bydgoszcz, Poland
        • Investigator Site 3
      • Lodz, Poland
        • Investigator Site 2
      • Trzebnica, Poland
        • Investigator Site 1
  • Slovakia
      • Banska Bystrica, Slovakia, 97409
        • Investigator Site 5
      • Bratislava, Slovakia, 82556
        • Investigator Site 3
      • Kosice, Slovakia, 04011
        • Investigator Site 2
      • Levice, Slovakia
        • Investigator Site 6
      • Liptovsky Mikulas, Slovakia
        • Investigator Site 7
      • Martin, Slovakia, 03659
        • Investigator Site 1
      • Poprad, Slovakia, 05845
        • Investigator Site 4
  • Spain
      • Barcelona, Spain, 08009
        • Investigator Site 5
      • Barcelona, Spain, 08208
        • Investigator Site 2
      • Girona, Spain, 17007
        • Investigator Site 4
      • Madrid, Spain, 28922
        • Investigator Site 3
      • Malaga, Spain
        • Investigator Site 7
      • Murcia, Spain
        • Investigator Site 6
      • Santiago de Compostela, Spain, 15706
        • Investigator Site 1
      • Sevilla, Spain
        • Investigator Site 8
  • Thailand
      • Chiang Mai, Thailand
        • Investigator Site 2
      • Khon Kaen, Thailand
        • Investigator site
  • United Kingdom
      • City Of Edinburgh, United Kingdom
        • Investigator Site 2
      • Kent, United Kingdom
        • Investigator Site 4
      • Liverpool, United Kingdom
        • Investigator Site 5
      • Nottingham, United Kingdom
        • Investigator Site 6
      • Oxford, United Kingdom
        • Investigator Site 1
      • Tooting, United Kingdom
        • Investigator Site 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 weeks to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ALX-0171
Inhalation of ALX-0171 during 3 consecutive days
Biological: ALX-0171
Placebo Comparator: Placebo
Inhalation of Placebo during 3 consecutive days
Other: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 day before first dose to 14 days after first dose

Secondary Outcome Measures

Outcome Measure
Time Frame
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
1 day before first dose to 14 days after first dose
Exploratory Pharmacokinetics as measured by the concentration of ALX-0171 in serum
Time Frame: Day 3
Day 3
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
1 day before first dose to 14 days after first dose
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
1 day before first dose to 14 days after first dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ablynx

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2014

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

November 27, 2014

First Submitted That Met QC Criteria

December 4, 2014

First Posted (Estimate)

December 5, 2014

Study Record Updates

Last Update Posted (Actual)

January 10, 2019

Last Update Submitted That Met QC Criteria

January 9, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALX0171-C104
  • 2014-002841-23 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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