Phase 2
N=180
Dose Ranging Study of ALX-0171 in Infants Hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection
Respiratory Syncytial Virus Lower Respiratory Tract Infection
Bottom Line
View on ClinicalTrials.gov: NCT02979431 ↗Enrolled (actual)
180
Serious AEs
8.6%
Results posted
Oct 2019
Primary outcome: Primary: Time for Viral Load to Drop Below Assay Quantification Limit (BQL) (Plaque Assay Analysis) — 46.1; 14.2; 5.1; 5.1 hours — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ALX-0171 3.0 mg/kg (Biological); ALX-0171 6.0 mg/kg (Biological); ALX-0171 9.0 mg/kg (Biological); Placebo (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Ablynx, a Sanofi company
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time for Viral Load to Drop Below Assay Quantification Limit (BQL) (Plaque Assay Analysis) |
46.1; 14.2; 5.1; 5.1 | <0.001 sig |
| SECONDARY Change From Baseline in Global Severity Score on Day 2 (5 Hours Post-dose) |
-3.6392; -3.8548; -4.1296; -4.2844 | =0.271 |
| SECONDARY Time-to-Clinical Response |
47.9; 44.1; 27.9; 46.3; 43.7; 44.0 | — |
| SECONDARY Time-to-BQL (RT-qPCR) |
26.7; 26.8; 28.9; 6.3 | — |
| SECONDARY Time-to-undetectable Viral Load (Plaque Assay Analysis) |
95.9; 26.3; 21.0; 5.1 | — |
| SECONDARY Viral Load Changes From Baseline (Plaque Assay Analysis) |
3.494; 3.312; 3.135; 2.385; -0.270; -2.173 | — |
| SECONDARY Viral Load Changes From Baseline (RT-qPCR Analysis) |
5.236; 4.966; 5.232; 4.525; -0.221; -0.544 | — |
| SECONDARY Viral Load Time-weighted Average Changes From Baseline (Plaque Assay Analysis) |
3.494; 3.312; 3.135; 2.385; -1.014; -1.924 | — |
| SECONDARY Viral Load Time-weighted Average Changes From Baseline (RT-qPCR Analysis) |
5.236; 4.966; 5.232; 4.525; -0.933; -1.209 | — |
| SECONDARY Immunogenicity; Number of Subjects With Treatment-emergent Anti-drug Antibodies |
10; 15; 16; 15; 16; 17 | — |
| SECONDARY Immunogenicity; Number of Subjects With Treatment-emergent Neutralizing Antibodies |
2; 11; 18; 12; 36; 33 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Male or female infant or young child aged 28 days to 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.
Exclusion Criteria
- 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.
- 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)
Data sourced from ClinicalTrials.gov (NCT02979431). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.