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CompletedNCT02979431RespireUpdated Oct 18, 2019Results posted

Dose Ranging Study of ALX-0171 in Infants Hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection

A Phase 2 interventional study of ALX-0171 3.0 mg/kg and ALX-0171 6.0 mg/kg in Respiratory Syncytial Virus Lower Respiratory Tract Infection, sponsored by Ablynx, a Sanofi company. Completed at 74 sites in 17 countries. Open to participants aged 28 Days to 2 Years. Per ClinicalTrials.gov, last updated 2019-10-18.

Sponsored by Ablynx, a Sanofi company · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
28 Days to 2 Years
Sex
All
01

Study 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). 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.

02

Conditions studied

  • Respiratory Syncytial Virus Lower Respiratory Tract Infection

Keywords

  • RSV, Lower Respiratory Tract Infection, pediattric patients
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 180 is above the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Ablynx, a Sanofi company is the lead sponsor of 24 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
28 Days to 2 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Male or female infant or young child aged 28 days to \< 2 years with gestational age ≥ 33 weeks at screening.
  2. Subject weighed between ≥ 3.0 kg and \< 15.0 kg at screening.
  3. 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.
  4. Subject had a positive RSV diagnostic test at screening.
  5. Subject was expected to have to stay in the hospital for at least 24 hours (according to the Investigator's judgment at screening).
  6. 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.

  7. 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
  8. Normal psychomotor development.

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. 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.
  3. Subject was known to be immunocompromised.
  4. 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.
  5. Subject had significant oral and/or maxillofacial malformations that would prevent proper positioning of the face mask.
  6. 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.
  7. 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).

  8. 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)
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
180 participants (actual)

Study arms

  • Experimental
    ALX-0171 3.0 mg/kg

    Inhalation of ALX-0171 3.0 mg/kg once daily for 3 consecutive days

    Biological: ALX-0171 3.0 mg/kg

  • Experimental
    ALX-0171 6.0 mg/kg

    Inhalation of ALX-0171 6.0 mg/kg once daily for 3 consecutive days

    Biological: ALX-0171 6.0 mg/kg

  • Experimental
    ALX-0171 Dose 9.0mg/kg

    Inhalation of ALX-0171 9.0 mg/kg once daily for 3 consecutive days

    Biological: ALX-0171 9.0 mg/kg

  • Placebo comparator
    Placebo

    Inhalation of Placebo once daily for 3 consecutive days

    Other: Placebo

Interventions

  • BiologicalALX-0171 3.0 mg/kg
  • BiologicalALX-0171 6.0 mg/kg
  • BiologicalALX-0171 9.0 mg/kg
  • OtherPlacebo

    Also known as: Matching Placebo

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Overall Study Period (i.e., approximately 28 days)

Secondary outcomes

  1. 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.

    Time frame: from Baseline untill Day 2 (5 hours post-dose)

  2. 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).

    Time frame: Overall Study Period (i.e., approximately 28 days)

  3. 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.

    Time frame: Overall Study Period (i.e., approximately 28 days)

  4. 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.

    Time frame: Overall Study Period (i.e., approximately 28 days)

  5. Viral Load Changes From Baseline (Plaque Assay Analysis)

    Change from Baseline in RSV Load measured by Plaque Assay (RSV Infected Population)

    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)

  6. Viral Load Changes From Baseline (RT-qPCR Analysis)

    Change from Baseline in RSV Load measured by RT-qPCR (RSV Infected Population)

    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)

  7. 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.

    Time frame: From Baseline until Day 14 (Follow-up) (Baseline, Day 3, and Follow-up reported)

  8. 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.

    Time frame: From Baseline until Day 14 (Follow-up) (Baseline, Day 3, and Follow-up reported)

  9. 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.

    Time frame: Overall Study Period (i.e., approximately 28 days)

  10. 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.

    Time frame: Overall Study Period (i.e., approximately 28 days)

07

Results

Posted Oct 18, 2019

Participant flow

Participant flow — Overall Study
MilestonePlaceboALX-0171 3.0 mg/kgALX-0171 6.0 mg/kgALX-0171 9.0mg/kg
Started44464545
Included in the mitt population42454345
Included in the safety population40454446
Completed40444344
Not completed4221
Withdrew: Parent/guardian withdrew consent2111
Withdrew: Randomized but received no study drug1100
Withdrew: Adverse event0010
Withdrew: Subject left country after day141000

Outcome measures

PrimaryTime 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.

Time frame:
Overall Study Period (i.e., approximately 28 days)
Reported as:
Median · hours
Time for Viral Load to Drop Below Assay Quantification Limit (BQL) (Plaque Assay Analysis)
hoursPlaceboALX-0171 3.0 mg/kgALX-0171 6.0 mg/kgALX-0171 9.0mg/kg
Time for Viral Load to Drop Below Assay Quantification Limit (BQL) (Plaque Assay Analysis)46.1 (29.33 to 94.42)14.2 (5.17 to 26.28)5.1 (4.78 to 24.72)5.1 (4.97 to 5.17)
Statistical analysis
  • Placebo vs ALX-0171 9.0mg/kg · Log Rank · p = <0.001
  • Placebo vs ALX-0171 6.0 mg/kg · Log Rank · p = =0.001
  • Placebo vs ALX-0171 3.0 mg/kg · Log Rank · p = <0.001
SecondaryChange 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.

Time frame:
from Baseline untill Day 2 (5 hours post-dose)
Reported as:
Least squares mean · score on a scale
Change From Baseline in Global Severity Score on Day 2 (5 Hours Post-dose)
score on a scalePlaceboALX-0171 3.0 mg/kgALX-0171 6.0 mg/kgALX-0171 9.0mg/kg
Change From Baseline in Global Severity Score on Day 2 (5 Hours Post-dose)-3.6392 ± 0.4160-3.8548 ± 0.4103-4.1296 ± 0.4129-4.2844 ± 0.4099
Statistical analysis
  • Placebo vs ALX-0171 9.0mg/kg · Mixed Models Analysis · p = =0.271 · Mean difference (net): -0.6452
  • Placebo vs ALX-0171 6.0 mg/kg · Mixed Models Analysis · p = =0.404 · Difference in ls means: -0.4904
  • Placebo vs ALX-0171 3.0 mg/kg · Mixed Models Analysis · p = =0.713 · Difference in ls means: -0.2156
SecondaryTime-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).

Time frame:
Overall Study Period (i.e., approximately 28 days)
Reported as:
Median · hours
Time-to-Clinical Response
hoursPlaceboALX-0171 3.0 mg/kgALX-0171 6.0 mg/kgALX-0171 9.0mg/kg
Time-to-Clinical Response47.9 (29.17 to 64.08)44.1 (28.33 to 51.20)27.9 (21.08 to 43.68)46.3 (38.00 to 50.38)
Time-to-adequate oral feeding43.7 (22.50 to 47.58)44.0 (25.92 to 52.00)17.6 (6.50 to 25.85)23.8 (17.17 to 38.00)
Time-to-adequate oxygen saturation53.4 (28.70 to 71.78)38.5 (24.75 to 61.93)29.5 (20.75 to 47.43)46.5 (42.15 to 48.25)
SecondaryTime-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.

Time frame:
Overall Study Period (i.e., approximately 28 days)
Reported as:
Median · hours
Time-to-BQL (RT-qPCR)
hoursPlaceboALX-0171 3.0 mg/kgALX-0171 6.0 mg/kgALX-0171 9.0mg/kg
Time-to-BQL (RT-qPCR)26.7 (5.0 to 49.92)26.8 (5.17 to 44.62)28.9 (18.25 to 49.25)6.3 (4.97 to 25.25)
SecondaryTime-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.

Time frame:
Overall Study Period (i.e., approximately 28 days)
Reported as:
Median · hours
Time-to-undetectable Viral Load (Plaque Assay Analysis)
hoursPlaceboALX-0171 3.0 mg/kgALX-0171 6.0 mg/kgALX-0171 9.0mg/kg
Time-to-undetectable Viral Load (Plaque Assay Analysis)95.9 (47.23 to 121.82)26.3 (20.25 to 28.92)21.0 (4.88 to 28.25)5.1 (5.00 to 5.87)
SecondaryViral Load Changes From Baseline (Plaque Assay Analysis)

Change from Baseline in RSV Load measured by Plaque Assay (RSV Infected Population)

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)
Reported as:
Mean · log10 pfu/mL
Viral Load Changes From Baseline (Plaque Assay Analysis)
log10 pfu/mLPlaceboALX-0171 3.0 mg/kgALX-0171 6.0 mg/kgALX-0171 9.0mg/kg
Baseline3.494 ± 0.23963.312 ± 0.21653.135 ± 0.24302.385 ± 0.2526
Day 1, 5 hours post-dose-0.270 ± 0.1607-2.173 ± 0.2123-2.189 ± 0.2676-1.535 ± 0.2526
Day 3, 2 hours post-dose-1.936 ± 0.2317-2.396 ± 0.2234-2.134 ± 0.2525-1.516 ± 0.2558
Follow-up-2.368 ± 0.2946-2.431 ± 0.2202-2.279 ± 0.2576-1.416 ± 0.2821
SecondaryViral Load Changes From Baseline (RT-qPCR Analysis)

Change from Baseline in RSV Load measured by RT-qPCR (RSV Infected Population)

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)
Reported as:
Mean · log10 copies/mL
Viral Load Changes From Baseline (RT-qPCR Analysis)
log10 copies/mLPlaceboALX-0171 3.0 mg/kgALX-0171 6.0 mg/kgALX-0171 9.0mg/kg
Baseline5.236 ± 0.28274.966 ± 0.20955.232 ± 0.18994.525 ± 0.2937
Day 1, 5 hours post-dose-0.221 ± 0.1601-0.544 ± 0.1286-0.241 ± 0.2031-0.449 ± 0.1883
Day 3, 2 hours post-dose-2.156 ± 0.2454-2.589 ± 0.2138-2.310 ± 0.2797-2.025 ± 0.2840
Follow-up-3.413 ± 0.3715-3.665 ± 0.2203-3.972 ± 0.2032-3.033 ± 0.3252
SecondaryViral 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.

Time frame:
From Baseline until Day 14 (Follow-up) (Baseline, Day 3, and Follow-up reported)
Reported as:
Mean · log10 pfu/mL
Viral Load Time-weighted Average Changes From Baseline (Plaque Assay Analysis)
log10 pfu/mLPlaceboALX-0171 3.0 mg/kgALX-0171 6.0 mg/kgALX-0171 9.0mg/kg
Baseline3.494 ± 0.23963.312 ± 0.21653.135 ± 0.24302.385 ± 0.2526
Day 3-1.014 ± 0.1540-1.924 ± 0.1659-1.804 ± 0.2098-1.330 ± 0.2434
Follow-Up-2.096 ± 0.2443-2.295 ± 0.2116-2.028 ± 0.2217-1.419 ± 0.2488
SecondaryViral 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.

Time frame:
From Baseline until Day 14 (Follow-up) (Baseline, Day 3, and Follow-up reported)
Reported as:
Mean · log10 copies/mL
Viral Load Time-weighted Average Changes From Baseline (RT-qPCR Analysis)
log10 copies/mLPlaceboALX-0171 3.0 mg/kgALX-0171 6.0 mg/kgALX-0171 9.0mg/kg
Baseline5.236 ± 0.28274.966 ± 0.20955.232 ± 0.18994.525 ± 0.2937
Day 3-0.933 ± 0.1421-1.209 ± 0.1301-1.113 ± 0.1932-0.842 ± 0.1842
Follow-up-2.684 ± 0.2263-2.828 ± 0.2099-2.756 ± 0.1831-2.292 ± 0.2581
SecondaryImmunogenicity; 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.

Time frame:
Overall Study Period (i.e., approximately 28 days)
Reported as:
Count of participants · Participants
Immunogenicity; Number of Subjects With Treatment-emergent Anti-drug Antibodies
ParticipantsPlaceboALX-0171 3.0 mg/kgALX-0171 6.0 mg/kgALX-0171 9.0mg/kg
Total TE ADA Positive10151615
Total TE ADA Negative16171413
TE ADA Equivocal12121314
TE ADA Inconclusive1114
SecondaryImmunogenicity; 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.

Time frame:
Overall Study Period (i.e., approximately 28 days)
Reported as:
Count of participants · Participants
Immunogenicity; Number of Subjects With Treatment-emergent Neutralizing Antibodies
ParticipantsPlaceboALX-0171 3.0 mg/kgALX-0171 6.0 mg/kgALX-0171 9.0mg/kg
Post-dose Positive2111812
Post-dose Negative36332631
Post-dose Missing1103

Adverse events

Collected over All adverse events (AEs) were reported from first study drug intake to the end of study visit (Day 28) or withdrawal visit.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/40 (0%)5/40 (12.5%)17/40 (42.5%)
ALX-0171 3.0 mg/kg0/45 (0%)4/45 (8.9%)16/45 (35.6%)
ALX-0171 6.0 mg/kg0/44 (0%)3/44 (6.8%)16/44 (36.4%)
ALX-0171 9.0mg/kg0/46 (0%)3/46 (6.5%)10/46 (21.7%)
Most frequent serious events
Showing 10 of 11
Most frequent serious events
EventPlaceboALX-0171 3.0 mg/kgALX-0171 6.0 mg/kgALX-0171 9.0mg/kg
Pneumonia bacterialInfections and infestations1/400/451/441/46
BronchiolitisInfections and infestations1/401/450/440/46
BronchitisInfections and infestations1/401/450/440/46
InfluenzaInfections and infestations1/400/450/440/46
Pneumonia viralInfections and infestations1/400/450/440/46
Respiratory failureRespiratory, thoracic and mediastinal disorders0/400/451/440/46
Vessel puncture site phlebitisGeneral disorders0/400/451/440/46
GastroenteritisInfections and infestations0/401/450/440/46
Respiratory syncytial virus infectionInfections and infestations0/401/450/440/46
Pneumonococcal bacteraemiaInfections and infestations0/400/450/441/46
Most frequent other events
Most frequent other events
EventPlaceboALX-0171 3.0 mg/kgALX-0171 6.0 mg/kgALX-0171 9.0mg/kg
RhinorrheaRespiratory, thoracic and mediastinal disorders1/406/453/442/46
PyrexiaGeneral disorders1/402/454/440/46
Upper respiratory tract infectionInfections and infestations3/403/453/442/46
Otitis mediaInfections and infestations3/400/450/440/46
CoughRespiratory, thoracic and mediastinal disorders1/402/453/442/46
RhinitisInfections and infestations0/400/451/443/46
AnaemiaBlood and lymphatic system disorders2/400/451/440/46
DiarrhoeaGastrointestinal disorders2/401/450/440/46
RashSkin and subcutaneous tissue disorders2/400/450/440/46
ConjuctivitisInfections and infestations2/402/451/441/46

Baseline characteristics

modified Intent-to-Treat Population (mITT): All randomized subjects who received at least 1 study drug administration. In this population, the subjects were classified as randomized (i.e.,using the treatment to which the subject was randomized).

Age, Categorical
Age, Categorical(Participants)PlaceboALX-0171 3.0 mg/kgALX-0171 6.0 mg/kgALX-0171 9.0mg/kgTotal
<=18 years42454345175
Between 18 and 65 years00000
>=65 years00000
Age, Continuous
Age, Continuous(months)PlaceboALX-0171 3.0 mg/kgALX-0171 6.0 mg/kgALX-0171 9.0mg/kgTotal
Mean6.964 ± 6.06686.933 ± 5.88276.657 ± 6.26057.022 ± 5.68846.896 ± 5.9234
Age, Customized
Age, Customized(Participants)PlaceboALX-0171 3.0 mg/kgALX-0171 6.0 mg/kgALX-0171 9.0mg/kgTotal
Age categories — < 6 months2423272599
Age categories — ≥ 6 months and < 12 months81371240
Age categories — ≥ 12 months1099836
Age, Customized
Age, Customized(Weeks)PlaceboALX-0171 3.0 mg/kgALX-0171 6.0 mg/kgALX-0171 9.0mg/kgTotal
Gestational Age38.5 ± 1.7838.6 ± 1.9938.6 ± 1.6238.3 ± 1.5438.5 ± 1.73
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboALX-0171 3.0 mg/kgALX-0171 6.0 mg/kgALX-0171 9.0mg/kgTotal
Female2415191775
Male18302428100
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)PlaceboALX-0171 3.0 mg/kgALX-0171 6.0 mg/kgALX-0171 9.0mg/kgTotal
Hispanic or Latino445518
Not Hispanic or Latino38413840157
Unknown or Not Reported00000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)PlaceboALX-0171 3.0 mg/kgALX-0171 6.0 mg/kgALX-0171 9.0mg/kgTotal
Race — Asian7731027
Race — Black or African American00101
Race — Multiple00202
Race — Other00134
Race — White35383632141
Region of Enrollment
Region of Enrollment(Participants)PlaceboALX-0171 3.0 mg/kgALX-0171 6.0 mg/kgALX-0171 9.0mg/kgTotal
Belgium23319
Bulgaria7861132
Chile00044
Colombia00101
Croatia668323
Germany10326
Hungary768425
Israel02114
Latvia212510
Malaysia443314
Philippines11035
Poland553013
Slovakia00224
Spain572115
Thailand221510

6 further baseline measures are reported on the registry.

08

Study locations

74 sites
  • Investigator site 2
    Brussels, Belgium
  • Investigator site
    Brussels, Belgium
  • Investigator Site
    Edegem, Belgium
  • Investigator Site
    Leuven, Belgium
  • Investigator site
    Roeselare, Belgium
  • Investigator Site
    Kozloduy, Bulgaria
  • Investigator Site
    Plovdiv, Bulgaria
  • Investigator Site
    Ruse, Bulgaria
  • Investigator Site
    Sofia, Bulgaria
  • Investigator Site
    Stara Zagora, Bulgaria
  • Investigator Site
    Santiago, Chile
  • Investigator site
    Valdivia, Chile
  • Investigator site
    Cali, Colombia
  • Investigator Site
    Floridablanca, Colombia
  • Investigator Site 1
    Medellín, Colombia
  • Investigator site 2
    Medellín, Colombia
  • Investigator site
    Cakovec, Croatia
  • Investigator site
    Osijek, Croatia
  • Investigator site
    Slavonski Brod, Croatia
  • Investigator site
    Varaždin, Croatia
  • Investigator site 1
    Zagreb, Croatia
  • Investigator site 2
    Zagreb, Croatia
  • Investigator site 3
    Zagreb, Croatia
  • Investigator site 4
    Zagreb, Croatia
  • Investigator site
    Hradec Králové, Czechia
  • Investigator Site
    Tartu, Estonia
  • Investigator site
    Bochum, Germany
  • Investigator site
    Dresden, Germany
  • Investigator Site
    Sankt Augustin, Germany
  • Investigator Site
    Wuppertal, Germany
  • Investigator Site
    Balassagyarmat, Hungary
  • Investigator site 1
    Budapest, Hungary
  • Investigator Site 2
    Budapest, Hungary
  • Investigator Site 3
    Budapest, Hungary
  • Investigator Site 4
    Budapest, Hungary
  • Investigator site
    Debrecen, Hungary
  • Investigator Site
    Szeged, Hungary
  • Investigator site
    Szekesfehervar, Hungary
  • Investigator Site
    Veszprém, Hungary
  • Investigator site
    Beer sheva, Israel
  • Investigator site
    Haifa, Israel
  • Investigator site
    Petah tikva, Israel
  • Investigator Site
    Daugavpils, Latvia
  • Investigator Site
    Riga, Latvia
  • Investigator site
    George Town, Malaysia
  • Investigator Site
    Kuala Lumpur, Malaysia
  • Investigator Site
    Seremban, Malaysia
  • Investigator Site
    Sibu, Malaysia
  • Investigator Site
    Alabang, Philippines
  • Investigator site
    Manila, Philippines
  • Investigator Site 1
    Quezon City, Philippines
  • Investigator Site 2
    Quezon City, Philippines
  • Investigator site
    Lublin, Poland
  • Investigator site
    Trzebnica, Poland
  • Investigator site
    Banská Bystrica, Slovakia
  • Investigator site
    Bratislava, Slovakia
  • Investigator site
    Košice, Slovakia
  • Investigator Site
    Poprad, Slovakia
  • Investigator Site 1
    Barcelona, Spain
  • Investigator Site 2
    Barcelona, Spain
  • Investigator Site 3
    Barcelona, Spain
  • Investigator Site
    Bilbao, Spain
  • Investigator Site
    El Palmar, Spain
  • Investigator site 1
    Madrid, Spain
  • Investigator Site 2
    Madrid, Spain
  • Investigator Site
    Málaga, Spain
  • Investigator site
    Santiago de Compostela, Spain
  • Investigator site
    Sevilla, Spain
  • Investigator Site
    Valencia, Spain
  • Investigator Site 1
    Bangkok, Thailand
  • Investigator site 2
    Bangkok, Thailand
  • Investigator Site
    Chiang Mai, Thailand
  • Investigator site
    Hat Yai, Thailand
  • Investigator Site
    Khon Kaen, Thailand
09

References and documents

Study documents

  • Study protocol · Oct 30, 2017
  • Statistical analysis plan · Aug 31, 2018

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02979431
Lead sponsor
Ablynx, a Sanofi company
Responsible party
Sponsor
First posted
Dec 1, 2016
Start date
Jan 11, 2017
Primary completion
May 25, 2018
Completion
May 25, 2018
Results posted
Oct 18, 2019
Last update
Oct 18, 2019

Study contacts

Ablynx Clinical Department
study director · Ablynx, a Sanofi company

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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