Respiratory Syncytial Virus InfectionPhase 1/2NCT02309320
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 1/2 study testing ALX-0171 in people with Respiratory Syncytial Virus Infection, run by Ablynx, a Sanofi company at 59 sites in 14 countries.
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. Read more about this study
- Who is it for?
- Ages 28 days to 23 months
- Conditions the study is for
- Respiratory Syncytial Virus Infection
- What is being tested?
- ALX-0171
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 59 sitesin 14 countries
- Study dates
- Dec 2014to Feb 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 days to 23 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
59 sites in 14 countries.
59 sites in 14 countries
Spain8 sites
Investigator Site 5
Barcelona, 08009
Investigator Site 2
Barcelona, 08208
Investigator Site 4
Girona, 17007
Investigator Site 3
Madrid, 28922
Investigator Site 7
Málaga
Investigator Site 6
Murcia
Investigator Site 1
Santiago de Compostela, 15706
Investigator Site 8
Seville
Slovakia7 sites
Investigator Site 5
Banská Bystrica, 97409
Investigator Site 3
Bratislava, 82556
Investigator Site 2
Košice, 04011
Investigator Site 6
Levice
Investigator Site 7
Liptovský Mikuláš
Investigator Site 1
Martin, 03659
Investigator Site 4
Poprad, 05845
Belgium6 sites
Investigator Site 1
Antwerp
Investigator Site 6
Antwerp
Investigator Site 4
Brussels
Investigator Site 5
Brussels
Investigator Site 2
Ghent
Investigator Site 3
Leuven
United Kingdom6 sites
Investigator Site 2
City of Edinburgh
Investigator Site 4
Kent
Investigator Site 5
Liverpool
Investigator Site 6
Nottingham
Investigator Site 1
Oxford
Investigator Site 3
Tooting
Hungary5 sites
Investigator Site 1
Budapest, 1083
Investigators Site 3
Budapest, 1089
Investigator Site 4
Budapest
Investigator Site 5
Budapest
Investigator Site 2
Szeged, 6720
Australia4 sites
Investigator Site 4
Brisbane
Investigator Site 2
Randwick, 2031
Investigator Site 3
Tasmania
Investigator Site 1
Westmead, 2145
Bulgaria4 sites
Investigator Site 4
Kozloduy
Investigator Site 1
Pleven
Investigator Site 2
Rousse
Investigator Site 3
Sevlievo
Malaysia4 sites
Investigator Site 2
Ipoh
Investigator Site 1
Kuala Lumpur
Investigator Site 3
Negeri Sembilan
Investigator Site 4
Pulau Pinang
Israel3 sites
Investigator Site 3
Beersheba
Investigator Site 2
Haifa
Investigator Site 1
Petah Tikva
Latvia3 sites
Investigator Site 3
Daugavpils
Investigator Site 2
Riga
Investigator Site 1
Valmiera
Philippines3 sites
Investigator Site
City of Muntinlupa
Investigator Site
Manila
Investigator Site
Quezon City
Poland3 sites
Investigator Site 3
Bydgoszcz
Investigator Site 2
Lodz
Investigator Site 1
Trzebnica
About this study
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.
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.
- Conditions
- Respiratory Syncytial Virus Infection
- Being tested
- ALX-0171, Placebo
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALX-0171Biological
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| ALX-0171 | Experimental | Inhalation of ALX-0171 during 3 consecutive days Receives: Biological: ALX-0171 |
| Placebo | Placebo comparator | Inhalation of Placebo during 3 consecutive days Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability as measured by the incidence of treatment emergent adverse events, clinical laboratory parameters and physical examination
Measured: 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
Measured: 1 day before first dose to 14 days after first dose
Exploratory Pharmacokinetics as measured by the concentration of ALX-0171 in serum
Measured: Day 3
Exploratory Pharmacodynamics as measured by the concentration of viral load in respiratory secretions and exploratory biomarkers in serum
Measured: 1 day before first dose to 14 days after first dose
Immunogenicity as measured by the concentration of anti-drug antibodies in serum
Measured: 1 day before first dose to 14 days after first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ablynx, a Sanofi company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ablynx Clinical Department, Study director, Ablynx, a Sanofi company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02309320
- Sponsor's protocol ID
- ALX0171-C104
- Other IDs
- 2014-002841-23, 2014
- Status last verified
- Jan 2019
- First submitted
- 27 Nov 2014
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02309320
- Acronym / sponsor ID
- ALX0171-C104
- Conditions
- Respiratory Syncytial Virus Infection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Ablynx, a Sanofi companyIndustry (pharma, biotech, devices)
- Study start
- Dec 2014 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 5 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALX-0171 | Experimental | Biological: ALX-0171Inhalation of ALX-0171 during 3 consecutive days |
| Placebo | Placebo comparator | Other: PlaceboInhalation of Placebo during 3 consecutive days |
Who may qualify
- Ages
- 28 days to 23 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALX-0171 | Biological | ALX-0171 |
| Placebo | Other | Placebo |
Primary outcome
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
4 secondary outcomes
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
Exploratory Pharmacokinetics as measured by the concentration of ALX-0171 in serum
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
Related trials for Respiratory Syncytial Virus Infection
RecruitingPhase 3
Study to Learn About a Respiratory Syncytial Virus Vaccine in Children at High Risk of RSV Disease
Respiratory Syncytial Virus (RSV)
Active, not recruitingPhase 3
A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease
Respiratory Syncytial Virus Infections
Active, not recruitingPhase 1
A Phase 1 Study to Evaluate JCXH-108, an mRNA-based Vaccine Against RSV
Respiratory Syncytial Virus (RSV), Infectious Disease
RecruitingPhase 2
Immunogenicity of RSVPreF3 Vaccine in Immunocompromised Persons
Respiratory Syncytial Virus (RSV)
RecruitingObservational study
TARSILA Real-World Evidence Study
Respiratory Syncytial Virus (RSV), Maternal Immunization
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ablynx Clinical Department study director
Ablynx, a Sanofi company
59 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ALX-0171 in people with Respiratory Syncytial Virus Infection, run by Ablynx, a Sanofi company at 59 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites in Spain, Slovakia, Belgium, United Kingdom, Hungary and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2019.