Respiratory Syncytial Virus Lower Respiratory Tract InfectionPhase 2RespireNCT02979431
Dose Ranging Study of ALX-0171 in Infants Hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection
A Phase 2 study testing ALX-0171 3.0 mg/kg, ALX-0171 6.0 mg/kg and ALX-0171 9.0 mg/kg in people with Respiratory Syncytial Virus Lower Respiratory Tract Infection, run by Ablynx, a Sanofi company at 74 sites in 17 countries.
Trial summary
The primary objective is to evaluate the anti-viral effect and safety of different doses of inhaled ALX-0171 in subjects hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection (RSV LRTI). Read more about this study
- Who is it for?
- Ages 28 days to 2 years
- Conditions the study is for
- Respiratory Syncytial Virus Lower Respiratory Tract Infection
- What is being tested?
- ALX-0171 3.0 mg/kg, ALX-0171 6.0 mg/kg and ALX-0171 9.0 mg/kg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 74 sitesin 17 countries
- Study dates
- 11 Jan 2017to 25 May 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female infant or young child aged 28 days to < 2 years with gestational age ≥ 33 weeks at screening.
- Subject weighed between ≥ 3.0 kg and < 15.0 kg at screening.
- Subject is otherwise healthy but was hospitalized for and clinically diagnosed with RSV LRTI (bronchiolitis or broncho-pneumonia), i.e., showing typical clinical signs and symptoms such as tachypnea, wheezing, cough, crackles, use of accessory muscles and/or nasal flaring.
- Subject had a positive RSV diagnostic test at screening.
- Subject was expected to have to stay in the hospital for at least 24 hours (according to the Investigator's judgment at screening).
- Symptoms were likely related to RSV infection (i.e., the symptoms present needed to be probably linked to the current RSV infection according to Investigator's judgment) had appeared within 4 days of screening and were not yet improving at screening and randomization.
Show all 15Show fewer
- Subject fulfilled at least 2 of the following RSV disease severity criteria at screening and randomization:
- Inadequate oral feeding that required feeding support (i.e., nasogastric tube or intravenous [i.v.] line)
- Inadequate oxygen saturation defined as:
- Oxygen saturation (peripheral capillary oxygen saturation [SpO2]) ≤ 92% on room air or
- Requiring oxygen supplementation to maintain oxygen saturation > 90% with documented pre-supplementation value ≤ 92%
- Signs of respiratory distress defined as:
- Respiratory rate ≥ 50 per minute in infants up to 12 months of age, and ≥ 40 per minute in children above 12 months and/or
- Moderate or marked respiratory muscle retractions
- Normal psychomotor development.
Who cannot join
- Subject was known to have significant comorbidities including:
- Genetic disorders (e.g., trisomy 21, cystic fibrosis),
- Hemodynamically significant congenital heart disease (e.g., needing corrective therapy or inotropic support),
- Bronchopulmonary dysplasia,
- Any hereditary or acquired metabolic (bone) diseases,
- Hematologic or other malignancy.
Show all 15Show fewer
- Subject was known to be human immunodeficiency virus (HIV)-positive. If the subject was < 6 months of age, a known HIV-positivity of the mother was also exclusionary.
- Subject was known to be immunocompromised.
- Subject had or was suspected to have an active, clinically relevant concurrent infection (e.g., bacterial pneumonia, urinary tract infection). Concurrent acute otitis media was not exclusionary.
- Subject had significant oral and/or maxillofacial malformations that would prevent proper positioning of the face mask.
- Subject received invasive mechanical ventilation or non-invasive respiratory support (i.e., continuous or bilevel positive airway pressure) in the 4 weeks prior to screening.
- During the admission, the subject was initially hospitalized in an intensive care unit (ICU) setting and/or had received invasive mechanical ventilation or non-invasive respiratory support (i.e., continuous or bilevel positive airway pressure).
- Subject was critically ill and/or was expected to require invasive mechanical ventilation, non invasive respiratory support (i.e., continuous or bilevel positive airway pressure), or High Flow oxygen therapy (HFOT) at levels not enabling nebulization therapy according to the Investigator's judgment. High Flow oxygen, with a maximum flow of 2 L/kg/min, was permitted under the following conditions:
- used as Standard of Care outside ICU setting
- could be removed for study drug administration (Note: oxygen flow at 2 L/min could be provided)
Trial locations and contacts
74 sites in 17 countries.
74 sites in 17 countries
Spain11 sites
Investigator Site 1
Barcelona
Investigator Site 2
Barcelona
Investigator Site 3
Barcelona
Investigator Site
Bilbao
Investigator Site
El Palmar
Investigator site 1
Madrid
Investigator Site 2
Madrid
Investigator Site
Málaga
Investigator site
Santiago de Compostela
Investigator site
Seville
Investigator Site
Valencia
Hungary9 sites
Investigator Site
Balassagyarmat
Investigator site 1
Budapest
Investigator Site 2
Budapest
Investigator Site 3
Budapest
Investigator Site 4
Budapest
Investigator site
Debrecen
Investigator Site
Szeged
Investigator site
Székesfehérvár
Investigator Site
Veszprém
Croatia8 sites
Investigator site
Čakovec
Investigator site
Osijek
Investigator site
Slavonski Brod
Investigator site
Varaždin
Investigator site 1
Zagreb
Investigator site 2
Zagreb
Investigator site 3
Zagreb
Investigator site 4
Zagreb
Belgium5 sites
Investigator site 2
Brussels
Investigator site
Brussels
Investigator Site
Edegem
Investigator Site
Leuven
Investigator site
Roeselare
Bulgaria5 sites
Investigator Site
Kozloduy
Investigator Site
Plovdiv
Investigator Site
Rousse
Investigator Site
Sofia
Investigator Site
Stara Zagora
Thailand5 sites
Investigator Site 1
Bangkok
Investigator site 2
Bangkok
Investigator Site
Chiang Mai
Investigator site
Hat Yai
Investigator Site
Khon Kaen
Colombia4 sites
Investigator site
Cali
Investigator Site
Floridablanca
Investigator Site 1
Medellín
Investigator site 2
Medellín
Germany4 sites
Investigator site
Bochum
Investigator site
Dresden
Investigator Site
Sankt Augustin
Investigator Site
Wuppertal
Malaysia4 sites
Investigator site
George Town
Investigator Site
Kuala Lumpur
Investigator Site
Seremban
Investigator Site
Sibu
Philippines4 sites
Investigator Site
Alabang
Investigator site
Manila
Investigator Site 1
Quezon City
Investigator Site 2
Quezon City
Slovakia4 sites
Investigator site
Banská Bystrica
Investigator site
Bratislava
Investigator site
Košice
Investigator Site
Poprad
Israel3 sites
Investigator site
Beersheba
Investigator site
Haifa
Investigator site
Petah Tikva
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Dose Ranging Study of ALX-0171 in Infants and Young Children Hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection
The primary objective is to evaluate the anti-viral effect and safety of different doses of inhaled ALX-0171 in subjects hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection (RSV LRTI). The secondary objective is to evaluate the clinical activity, pharmacokinetic (PK) properties, pharmacodynamic (PD) effect and immunogenicity of different doses of inhaled ALX-0171.
Read the detailed description
This was a Phase 2b, randomized, double-blind, placebo-controlled, international, multicenter dose-ranging study in infants and toddlers hospitalized for RSV LRTI. The study evaluated 3 dose levels of ALX-0171 in a sequential part (safety Cohorts 1-3) followed by a parallel part (Cohort 4).
An Independent Data Monitoring Committee (IDMC) was assigned to review study data and provide recommendations on proceeding to the next safety cohort and on which dose levels could be taken forward in the parallel part.
Three dose levels of ALX-0171 were evaluated:
- Dose 1: target dose of 3.0 mg/kg
- Dose 2: target dose of 6.0 mg/kg
- Dose 3: target dose of 9.0 mg/kg
The study drug was administered by inhalation once daily for 3 consecutive days along with standard of care treatment, which was determined by the Investigator (or his/her designee) according to institutional practice.
- Being tested
- ALX-0171 3.0 mg/kg, ALX-0171 6.0 mg/kg, ALX-0171 9.0 mg/kg, Placebo
- Keywords
- RSV, Lower Respiratory Tract Infection, pediattric patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALX-0171 3.0 mg/kgBiological
ALX-0171 6.0 mg/kgBiological
ALX-0171 9.0 mg/kgBiological
PlaceboOther
Also called Matching Placebo
| Study group | Role | What they receive |
|---|---|---|
| ALX-0171 3.0 mg/kg | Experimental | Inhalation of ALX-0171 3.0 mg/kg once daily for 3 consecutive days Receives: Biological: ALX-0171 3.0 mg/kg |
| ALX-0171 6.0 mg/kg | Experimental | Inhalation of ALX-0171 6.0 mg/kg once daily for 3 consecutive days Receives: Biological: ALX-0171 6.0 mg/kg |
| ALX-0171 Dose 9.0mg/kg | Experimental | Inhalation of ALX-0171 9.0 mg/kg once daily for 3 consecutive days Receives: Biological: ALX-0171 9.0 mg/kg |
| Placebo | Placebo comparator | Inhalation of Placebo once daily for 3 consecutive days Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time for Viral Load to Drop Below Assay Quantification Limit (BQL) (Plaque Assay Analysis)
The primary endpoint for this trial was the time needed for the viral load to drop below the quantification limit (time-to-BQL) of the plaque assay in nasal mid-turbinate swab specimens. Time-to-BQL was defined as the time from the first study drug administration to the first occurrence of a value below the quantification limit (BQL), provided the next measured value was also below the limit of quantification. The time to BQL for subjects with missing data and/or who did not reach BQL during the trial were censored at the last non-missing viral load assessment. The primary endpoint was analysed using logrank test to compare time-to-BQL between each of the ALX-0171 treatment groups and the combined placebo group. The tests were performed in a sequential way to preserve the family-wise error rate at 0.05. The comparisons were performed in the following order: ALX-0171 9 mg/kg vs Placebo, followed by ALX-0171 6mg/kg vs Placebo, ALX-0171 3mg/kg vs Placebo.
Measured: Overall Study Period (i.e., approximately 28 days)
Secondary outcomes (10)
Change From Baseline in Global Severity Score on Day 2 (5 Hours Post-dose)
A formal comparison for change from Baseline in GSS to Day 2, 5 hours post-dose was performed using a contrast analysis on a longitudinal mixed model with random factor subject and fixed effects baseline value, treatment group and timepoint, including the treatment-by-timepoint interaction term. All data up to and including Day 3 were used in the longitudinal mixed model. The Kenward-Roger approximation of degrees of freedom was used. The model was fitted using an unstructured variance-covariance matrix.
The individual pair-wise comparisons were reported (comparison in least square [LS] means for 9.0 mg/kg versus placebo; 6.0mg/kg versus placebo; 3.0 mg/kg versus placebo).
Evolution over time in Global Severity Score. The maximum total score is 20 (minimum:0 to manimum:20); higher score indicates more severe disease.
Measured: from Baseline untill Day 2 (5 hours post-dose)
Time-to-Clinical Response
The time-to-clinical response was defined as the time between the first study drug administration and the time of achieving adequate oxygen saturation (defined as SpO2 > 92% over a period of at least 4 hours) and adequate oral feeding (which is sufficient to maintain sufficient hydration, in the judgment of the Investigator).
Measured: Overall Study Period (i.e., approximately 28 days)
Time-to-BQL (RT-qPCR)
As secondary endpoint, the time-to-BQL using RT-qPCR was summarized using Kaplan Meier (KM) estimates. No p-values were calculated. For RSV load by RT-qPCR, the lower limit of quantification (LLOQ) was 2.4 log10 copies/mL.
The upper limit confidence interval (CI) could not be calculated; Values of the 25 percentile are reported here.
Measured: Overall Study Period (i.e., approximately 28 days)
Time-to-undetectable Viral Load (Plaque Assay Analysis)
The time-to-undetectability (hours), defined as the time from the first study drug administration to the first occurrence of viral titer below the lower limit of quantification (LLOQ), and target not detected provided the next measured value was also below the quantification limit and undetected, were summarized using KM estimates, based on the plaque assay. The time-to-event for subjects with missing data and/or subjects who did not reach undetectability during the trial were censored at the last non-missing viral load assessment. For RSV load by plaque assay the LLOQ was 1.7 log10 pfu/mL.
Measured: Overall Study Period (i.e., approximately 28 days)
Viral Load Changes From Baseline (Plaque Assay Analysis)
Change from Baseline in RSV Load measured by Plaque Assay (RSV Infected Population)
Measured: From Baseline until Day 14 (Follow-up) (Baseline; Day 1, 5 hours post-dose; Day 3, 2 hours post-dose; and Follow-up reported)
Viral Load Changes From Baseline (RT-qPCR Analysis)
Change from Baseline in RSV Load measured by RT-qPCR (RSV Infected Population)
Measured: From Baseline until Day 14 (Follow-up) (Baseline; Day 1, 5 hours post-dose; Day 3, 2 hours post-dose; and Follow-up reported)
Viral Load Time-weighted Average Changes From Baseline (Plaque Assay Analysis)
The time-weighted average change from baseline to Day x was defined as (AUCx - x* viral load at baseline) /x, where AUCx denotes the AUC between baseline and Day x. For subjects who only had data up to Day t (t<x), the endpoint was defined as (AUCt - t*viral load at baseline) / t.
Measured: From Baseline until Day 14 (Follow-up) (Baseline, Day 3, and Follow-up reported)
Viral Load Time-weighted Average Changes From Baseline (RT-qPCR Analysis)
The time-weighted average change from baseline to Day x was defined as (AUCx - x* viral load at baseline) /x, where AUCx denotes the AUC between baseline and Day x. For subjects who only had data up to Day t (t<x), the endpoint was defined as (AUCt - t*viral load at baseline) / t.
Measured: From Baseline until Day 14 (Follow-up) (Baseline, Day 3, and Follow-up reported)
Immunogenicity; Number of Subjects With Treatment-emergent Anti-drug Antibodies
The number of subjects with treatment-emergent (TE) anti-drug antibodies (ADA; TE ADA) based on ADA assay by treatment group for the Safety Population. Blood samples for immunogenicity assessments were collected at Baseline and on Day 14.
Immunogenicity data were analyzed using the Safety Population. This population differs from the ITT and mITT Populations as 2 subjects who were originally randomized to placebo, received active treatment once; one subject received ALX-0171 6.0 mg/kg and one subject ALX-0171 9.0 mg/kg.
Measured: Overall Study Period (i.e., approximately 28 days)
Immunogenicity; Number of Subjects With Treatment-emergent Neutralizing Antibodies
Number of subjects with treatment-emergent neutralizing antibodies (TE NAb) as detected with the competitive ligand binding NAb assay. Blood samples for immunogenicity assessments were collected at Baseline and on Day 14.
Immunogenicity data were analyzed using the Safety Population. This population differs from the ITT and mITT Populations as 2 subjects who were originally randomized to placebo, received active treatment once; one subject received ALX-0171 6.0 mg/kg and one subject ALX-0171 9.0 mg/kg.
Measured: Overall Study Period (i.e., approximately 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2016 (estimated)
- Study start11 Jan 2017
- Primary completion25 May 2018
- Study completion25 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Respiratory Syncytial Virus Lower Respiratory Tract 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 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
- NCT02979431
- Sponsor's protocol ID
- ALX0171-C201
- Other IDs
- 2016-001651-49, 2016
- Acronym
- Respire
- Status last verified
- Sep 2019
- First submitted
- 29 Nov 2016
- Last updated
- 18 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multicenter Dose Ranging Study of ALX-0171 in Infants and Young Children Hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection
- ClinicalTrials.gov ID
- NCT02979431
- Acronym / sponsor ID
- Respire / ALX0171-C201
- Keywords
- RSV, Lower Respiratory Tract Infection, pediattric patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Ablynx, a Sanofi companyIndustry (pharma, biotech, devices)
- Study start
- 11 Jan 2017 (actual)
- Primary completion
- 25 May 2018 (actual)
- Study completion
- 25 May 2018 (actual)
- First posted
- 1 Dec 2016 (estimated)
- Results
- Posted 18 Oct 2019
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 is to evaluate the anti-viral effect and safety of different doses of inhaled ALX-0171 in subjects hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection (RSV LRTI). The secondary objective is to evaluate the clinical activity, pharmacokinetic (PK) properties, pharmacodynamic (PD) effect and immunogenicity of different doses of inhaled ALX-0171.
Detailed description
This was a Phase 2b, randomized, double-blind, placebo-controlled, international, multicenter dose-ranging study in infants and toddlers hospitalized for RSV LRTI. The study evaluated 3 dose levels of ALX-0171 in a sequential part (safety Cohorts 1-3) followed by a parallel part (Cohort 4).
An Independent Data Monitoring Committee (IDMC) was assigned to review study data and provide recommendations on proceeding to the next safety cohort and on which dose levels could be taken forward in the parallel part.
Three dose levels of ALX-0171 were evaluated:
- Dose 1: target dose of 3.0 mg/kg
- Dose 2: target dose of 6.0 mg/kg
- Dose 3: target dose of 9.0 mg/kg
The study drug was administered by inhalation once daily for 3 consecutive days along with standard of care treatment, which was determined by the Investigator (or his/her designee) according to institutional practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ALX-0171 3.0 mg/kg | Experimental | Biological: ALX-0171 3.0 mg/kgInhalation of ALX-0171 3.0 mg/kg once daily for 3 consecutive days |
| ALX-0171 6.0 mg/kg | Experimental | Biological: ALX-0171 6.0 mg/kgInhalation of ALX-0171 6.0 mg/kg once daily for 3 consecutive days |
| ALX-0171 Dose 9.0mg/kg | Experimental | Biological: ALX-0171 9.0 mg/kgInhalation of ALX-0171 9.0 mg/kg once daily for 3 consecutive days |
| Placebo | Placebo comparator | Other: PlaceboInhalation of Placebo once daily for 3 consecutive days |
Who may qualify
- Ages
- 28 days to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (15 listed)
- Male or female infant or young child aged 28 days to < 2 years with gestational age ≥ 33 weeks at screening.
- Subject weighed between ≥ 3.0 kg and < 15.0 kg at screening.
- Subject is otherwise healthy but was hospitalized for and clinically diagnosed with RSV LRTI (bronchiolitis or broncho-pneumonia), i.e., showing typical clinical signs and symptoms such as tachypnea, wheezing, cough, crackles, use of accessory muscles and/or nasal flaring.
- Subject had a positive RSV diagnostic test at screening.
- Subject was expected to have to stay in the hospital for at least 24 hours (according to the Investigator's judgment at screening).
Key exclusion criteria (15 listed)
- Subject was known to have significant comorbidities including:
- Subject was known to be human immunodeficiency virus (HIV)-positive. If the subject was < 6 months of age, a known HIV-positivity of the mother was also exclusionary.
- Subject was known to be immunocompromised.
- Subject had or was suspected to have an active, clinically relevant concurrent infection (e.g., bacterial pneumonia, urinary tract infection). Concurrent acute otitis media was not exclusionary.
- Subject had significant oral and/or maxillofacial malformations that would prevent proper positioning of the face mask.
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 3.0 mg/kg | Biological | ALX-0171 3.0 mg/kg |
| ALX-0171 6.0 mg/kg | Biological | ALX-0171 6.0 mg/kg |
| ALX-0171 9.0 mg/kg | Biological | ALX-0171 Dose 9.0mg/kg |
| PlaceboAlso: Matching Placebo | Other | Placebo |
Primary outcome
Time for Viral Load to Drop Below Assay Quantification Limit (BQL) (Plaque Assay Analysis)
Time frame: Overall Study Period (i.e., approximately 28 days)
The primary endpoint for this trial was the time needed for the viral load to drop below the quantification limit (time-to-BQL) of the plaque assay in nasal mid-turbinate swab specimens. Time-to-BQL was defined as the time from the first study drug administration to the first occurrence of a value below the quantification limit (BQL), provided the next measured value was also below the limit of quantification. The time to BQL for subjects with missing data and/or who did not reach BQL during the trial were censored at the last non-missing viral load assessment. The primary endpoint was analysed using logrank test to compare time-to-BQL between each of the ALX-0171 treatment groups and the combined placebo group. The tests were performed in a sequential way to preserve the family-wise error rate at 0.05. The comparisons were performed in the following order: ALX-0171 9 mg/kg vs Placebo, followed by ALX-0171 6mg/kg vs Placebo, ALX-0171 3mg/kg vs Placebo.
10 secondary outcomes
Change From Baseline in Global Severity Score on Day 2 (5 Hours Post-dose)
Time frame: from Baseline untill Day 2 (5 hours post-dose)
Time-to-Clinical Response
Time frame: Overall Study Period (i.e., approximately 28 days)
Time-to-BQL (RT-qPCR)
Time frame: Overall Study Period (i.e., approximately 28 days)
Time-to-undetectable Viral Load (Plaque Assay Analysis)
Time frame: Overall Study Period (i.e., approximately 28 days)
Viral Load Changes From Baseline (Plaque Assay Analysis)
Time frame: From Baseline until Day 14 (Follow-up) (Baseline; Day 1, 5 hours post-dose; Day 3, 2 hours post-dose; and Follow-up reported)
Viral Load Changes From Baseline (RT-qPCR Analysis)
Time frame: From Baseline until Day 14 (Follow-up) (Baseline; Day 1, 5 hours post-dose; Day 3, 2 hours post-dose; and Follow-up reported)
Viral Load Time-weighted Average Changes From Baseline (Plaque Assay Analysis)
Time frame: From Baseline until Day 14 (Follow-up) (Baseline, Day 3, and Follow-up reported)
Viral Load Time-weighted Average Changes From Baseline (RT-qPCR Analysis)
Time frame: From Baseline until Day 14 (Follow-up) (Baseline, Day 3, and Follow-up reported)
Immunogenicity; Number of Subjects With Treatment-emergent Anti-drug Antibodies
Time frame: Overall Study Period (i.e., approximately 28 days)
Immunogenicity; Number of Subjects With Treatment-emergent Neutralizing Antibodies
Time frame: Overall Study Period (i.e., approximately 28 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
74 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ALX-0171 3.0 mg/kg, ALX-0171 6.0 mg/kg and ALX-0171 9.0 mg/kg in people with Respiratory Syncytial Virus Lower Respiratory Tract Infection, run by Ablynx, a Sanofi company at 74 sites in 17 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 15 inclusion and 15 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 18 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 74 sites in Spain, Hungary, Croatia, Belgium, Bulgaria and 12 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 phase mean?
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?
Yes. Results are posted in the registry (first posted 18 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time for Viral Load to Drop Below Assay Quantification Limit (BQL) (Plaque Assay Analysis) (time frame: Overall Study Period (i.e., approximately 28 days)). 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 18 Oct 2019.