Phase 2b dose-ranging study of ALX-0171 in infants and young children hospitalized for RSV lower respiratory tract infectio
- Conditions
- RSV lower respiratory tract infectionMedDRA version: 20.1Level: PTClassification code 10061603Term: Respiratory syncytial virus infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2016-001651-49-SK
- Lead Sponsor
- Ablynx NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 180
- Subject is a male or female infant or young child aged 28 days to < 2 years with gestational age = 33 weeks at screening.
- Subject is otherwise healthy, but is hospitalized for and clinically diagnosed with RSV lower respiratory tract infection.
- Subject has a positive RSV diagnostic test at screening.
- Subject is expected to have to stay in the hospital for at least 24 hours.
- Parent(s)/legal guardian(s) provide written informed consent in accordance with locally approved consent process at screening.
Are the trial subjects under 18? yes
Number of subjects for this age range: 180
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- Subject is known to have significant comorbidities
- Subject is known to be HIV-positive (or if the child is <6 months of age, the mother is known to be HIV-positive).
- Subject is known to be immunocompromised.
- Subject has or is suspected to have an active, clinically relevant concurrent infection
- Subject is critically ill and/or is expected to require invasive mechanical ventilation
- Subject is currently participating in any other study with investigational drug or has received an investigational drug within 4 weeks or 5 half-lives of the concerned drug (whichever is longer) prior to screening
- Subject was previously enrolled in a clinical study of ALX-0171
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the anti-viral effect and safety of different doses of inhaled ALX-0171 in subjects hospitalized for RSV lower respiratory tract infection. ;Secondary Objective: To evaluate the clinical activity, pharmacokinetic (PK) properties, pharmacodynamic (PD) effect and immunogenicity of different doses of inhaled ALX-0171. ;Primary end point(s): Anti-viral effect, as measured by the time needed for the viral load to drop below the assay quantification limit.;Timepoint(s) of evaluation of this end point: Throughout the in-hospital period, up to Day 14 after randomization
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Safety assessment (assessed by physical examination, AEs, laboratory assessments and vital signs) of different doses of ALX-0171<br>- Change from baseline in Global Severity Score<br>- Time to clinical response <br>- PK properties of ALX-0171 <br>- Viral load profile over time <br>- Evaluation of serum anti-drug antibodies (ADA)<br>;Timepoint(s) of evaluation of this end point: Throughout the study, up to Day 28 after randomization