Trial · NCT02979431
Dose Ranging Study of ALX-0171 in Infants Hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection
NCT02979431, Phase 2, Completed, Ablynx, a Sanofi company; results first posted 2019-10-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Dose Ranging Study of ALX-0171 in Infants Hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection. Trials, record NCT02979431. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02979431
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dose Ranging Study of ALX-0171 in Infants Hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection
- NCT number
- NCT02979431
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 180 participants, actual
- Lead sponsor
- Ablynx, a Sanofi company
- Conditions
- Respiratory Syncytial Virus Lower Respiratory Tract Infection
- Interventions
- ALX-0171 3.0 mg/kg, ALX-0171 6.0 mg/kg, ALX-0171 9.0 mg/kg, Placebo
- First posted
- 2016-12-01
- Last updated
- 2019-10-18
- Other registries' IDs
- eudract:2016-001651-49
- Results first posted
- 2019-10-18
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time for Viral Load to Drop Below Assay Quantification Limit (BQL) (Plaque Assay Analysis) | 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. |
| Secondary | Change From Baseline in Global Severity Score on Day 2 (5 Hours Post-dose) | from Baseline untill 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. |
| Secondary | Time-to-Clinical Response | Overall Study Period (i.e., approximately 28 days) | 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). |
| Secondary | Time-to-BQL (RT-qPCR) | Overall Study Period (i.e., approximately 28 days) | 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. |
| Secondary | Time-to-undetectable Viral Load (Plaque Assay Analysis) | Overall Study Period (i.e., approximately 28 days) | 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. |
| Secondary | Viral Load Changes From Baseline (Plaque Assay Analysis) | From Baseline until Day 14 (Follow-up) (Baseline; Day 1, 5 hours post-dose; Day 3, 2 hours post-dose; and Follow-up reported) | Change from Baseline in RSV Load measured by Plaque Assay (RSV Infected Population) |
| Secondary | Viral Load Changes From Baseline (RT-qPCR Analysis) | From Baseline until Day 14 (Follow-up) (Baseline; Day 1, 5 hours post-dose; Day 3, 2 hours post-dose; and Follow-up reported) | Change from Baseline in RSV Load measured by RT-qPCR (RSV Infected Population) |
| Secondary | Viral Load Time-weighted Average Changes From Baseline (Plaque Assay Analysis) | From Baseline until Day 14 (Follow-up) (Baseline, Day 3, and Follow-up reported) | 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. |
| Secondary | Viral Load Time-weighted Average Changes From Baseline (RT-qPCR Analysis) | From Baseline until Day 14 (Follow-up) (Baseline, Day 3, and Follow-up reported) | 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. |
| Secondary | Immunogenicity; Number of Subjects With Treatment-emergent Anti-drug Antibodies | Overall Study Period (i.e., approximately 28 days) | 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time for Viral Load to Drop Below Assay Quantification Limit (BQL) (Plaque Assay Analysis) | Overall Study Period (i.e., approximately 28 days) | 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). | hours | MEDIAN |
| SECONDARY | Change From Baseline in Global Severity Score on Day 2 (5 Hours Post-dose) | from Baseline untill Day 2 (5 hours post-dose) | score on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Time-to-Clinical Response | Overall Study Period (i.e., approximately 28 days) | 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). | hours | MEDIAN |
| SECONDARY | Time-to-BQL (RT-qPCR) | Overall Study Period (i.e., approximately 28 days) | The modified ITT (mITT) population consisted of all randomized subjects who received at least 1 administration of study drug. When using this population, the subjects were classified as randomized (i.e., using the treatment to which the subject was randomized). | hours | MEDIAN |
| SECONDARY | Time-to-undetectable Viral Load (Plaque Assay Analysis) | Overall Study Period (i.e., approximately 28 days) | RSV-Infected Population: A central RSV test was used for defining the RSV-Infected population. The RSV-Infected population consisted of all randomized subjects with RSV infection, as confirmed by RT-qPCR (hVIVO quantitative PCR assay) on Day 1 (pre- or post-dose), who received at least 1 administration of study drug. | hours | MEDIAN |
| SECONDARY | Viral Load Changes From Baseline (Plaque Assay Analysis) | From Baseline until Day 14 (Follow-up) (Baseline; Day 1, 5 hours post-dose; Day 3, 2 hours post-dose; and Follow-up reported) | RSV-Infected Population: A central RSV test was used for defining the RSV-Infected population. The RSV-Infected population consisted of all randomized subjects with RSV infection, as confirmed by RT-qPCR (hVIVO quantitative PCR assay) on Day 1 (pre- or post-dose), who received at least 1 administration of study drug. | log10 pfu/mL | MEAN |
| SECONDARY | Viral Load Changes From Baseline (RT-qPCR Analysis) | From Baseline until Day 14 (Follow-up) (Baseline; Day 1, 5 hours post-dose; Day 3, 2 hours post-dose; and Follow-up reported) | RSV-Infected Population: A central RSV test was used for defining the RSV-Infected population. The RSV-Infected population consisted of all randomized subjects with RSV infection, as confirmed by RT-qPCR (hVIVO quantitative PCR assay) on Day 1 (pre- or post-dose), who received at least 1 administration of study drug. | log10 copies/mL | MEAN |
| SECONDARY | Viral Load Time-weighted Average Changes From Baseline (Plaque Assay Analysis) | From Baseline until Day 14 (Follow-up) (Baseline, Day 3, and Follow-up reported) | RSV-Infected Population: A central RSV test was used for defining the RSV-Infected population. The RSV-Infected population consisted of all randomized subjects with RSV infection, as confirmed by RT-qPCR (hVIVO quantitative PCR assay) on Day 1 (pre- or post-dose), who received at least 1 administration of study drug. | log10 pfu/mL | MEAN |
| SECONDARY | Viral Load Time-weighted Average Changes From Baseline (RT-qPCR Analysis) | From Baseline until Day 14 (Follow-up) (Baseline, Day 3, and Follow-up reported) | RSV-Infected Population: A central RSV test was used for defining the RSV-Infected population. The RSV-Infected population consisted of all randomized subjects with RSV infection, as confirmed by RT-qPCR (hVIVO quantitative PCR assay) on Day 1 (pre- or post-dose), who received at least 1 administration of study drug. | log10 copies/mL | MEAN |
| SECONDARY | Immunogenicity; Number of Subjects With Treatment-emergent Anti-drug Antibodies | Overall Study Period (i.e., approximately 28 days) | The Safety Population consisted of all subjects who received at least 1 administration of study drug. When using this population, the subjects were classified as treated (i.e., using the treatment that the subject actually received). Number of subjects with non-missing ADA results were: placebo:39; ALX-0171 3.0mg/kg:45; 6.0mg/kg:44; 9.0mg/kg:46. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group112
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time for Viral Load to Drop Below Assay Quantification Limit (BQL) (Plaque Assay Analysis) | Placebo | 46.1 | 95% Confidence Interval 29.33 to 94.42 | hours | |
| Time for Viral Load to Drop Below Assay Quantification Limit (BQL) (Plaque Assay Analysis) | ALX-0171 3.0 mg/kg | 14.2 | 95% Confidence Interval 5.17 to 26.28 | hours | |
| Time for Viral Load to Drop Below Assay Quantification Limit (BQL) (Plaque Assay Analysis) | ALX-0171 6.0 mg/kg | 5.1 | 95% Confidence Interval 4.78 to 24.72 | hours | |
| Time for Viral Load to Drop Below Assay Quantification Limit (BQL) (Plaque Assay Analysis) | ALX-0171 9.0mg/kg | 5.1 | 95% Confidence Interval 4.97 to 5.17 | hours | |
| Change From Baseline in Global Severity Score on Day 2 (5 Hours Post-dose) | Placebo | -3.6392 | Standard Error 0.4160 | score on a scale | |
| Change From Baseline in Global Severity Score on Day 2 (5 Hours Post-dose) | ALX-0171 3.0 mg/kg | -3.8548 | Standard Error 0.4103 | score on a scale | |
| Change From Baseline in Global Severity Score on Day 2 (5 Hours Post-dose) | ALX-0171 6.0 mg/kg | -4.1296 | Standard Error 0.4129 | score on a scale | |
| Change From Baseline in Global Severity Score on Day 2 (5 Hours Post-dose) | ALX-0171 9.0mg/kg | -4.2844 | Standard Error 0.4099 | score on a scale | |
| Time-to-Clinical Response | Placebo | Time-to-Clinical Response | 47.9 | 95% Confidence Interval 29.17 to 64.08 | hours |
| Time-to-Clinical Response | ALX-0171 3.0 mg/kg | Time-to-Clinical Response | 44.1 | 95% Confidence Interval 28.33 to 51.20 | hours |
1 to 10 of 112Source ClinicalTrials.gov
See all 112 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 44 | |
| Overall Study | STARTED | ALX-0171 3.0 mg/kg | 46 | |
| Overall Study | STARTED | ALX-0171 6.0 mg/kg | 45 | |
| Overall Study | STARTED | ALX-0171 9.0mg/kg | 45 | |
| Overall Study | Included in the mITT Population | Placebo | 42 | |
| Overall Study | Included in the mITT Population | ALX-0171 3.0 mg/kg | 45 | |
| Overall Study | Included in the mITT Population | ALX-0171 6.0 mg/kg | 43 | |
| Overall Study | Included in the mITT Population | ALX-0171 9.0mg/kg | 45 | |
| Overall Study | Included in the Safety Population | Placebo | 40 | |
| Overall Study | Included in the Safety Population | ALX-0171 3.0 mg/kg | 45 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events84
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 2 | 40 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | ALX-0171 3.0 mg/kg | 0 | 45 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | ALX-0171 6.0 mg/kg | 1 | 44 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | ALX-0171 9.0mg/kg | 0 | 46 | 0 |
| other | Rhinorrhea | Respiratory, thoracic and mediastinal disorders | Placebo | 1 | 40 | 1 |
| other | Rhinorrhea | Respiratory, thoracic and mediastinal disorders | ALX-0171 3.0 mg/kg | 6 | 45 | 7 |
| other | Rhinorrhea | Respiratory, thoracic and mediastinal disorders | ALX-0171 6.0 mg/kg | 3 | 44 | 3 |
| other | Rhinorrhea | Respiratory, thoracic and mediastinal disorders | ALX-0171 9.0mg/kg | 2 | 46 | 2 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Placebo | 1 | 40 | 1 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | ALX-0171 3.0 mg/kg | 2 | 45 | 2 |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 40 |
| Total, all-cause mortality | ALX-0171 3.0 mg/kg | 0 | 45 |
| Total, all-cause mortality | ALX-0171 6.0 mg/kg | 0 | 44 |
| Total, all-cause mortality | ALX-0171 9.0mg/kg | 0 | 46 |
| Total, other adverse events | Placebo | 17 | 40 |
| Total, other adverse events | ALX-0171 3.0 mg/kg | 16 | 45 |
| Total, other adverse events | ALX-0171 6.0 mg/kg | 16 | 44 |
| Total, other adverse events | ALX-0171 9.0mg/kg | 10 | 46 |
| Total, serious adverse events | Placebo | 5 | 40 |
| Total, serious adverse events | ALX-0171 3.0 mg/kg | 4 | 45 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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Read this trial from software.
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