Respiratory Syncytial Virus Infection MedDRA version: 20.1 Level: PT Classification code 10061603 Term: Respiratory syncytial virus infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: ALX-0171
Product Code: ALX-0171
Pharmaceutical Form: Nebuliser solution
INN or Proposed INN: not assigned
CAS Number: not assigned
Current Sponsor code: ALX-0171
Other descriptive name:
Sponsors
Ablynx NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject is male or female, inpatient/outpatient, agend 18-75 years at screening 2. Subject has received an HSCT using any conditioning regiment and for any underlying etiology (an autologous HSCT within 90 days of screening or an allogeneic HSCT within 180 days of screening or an allogeneic HSCT within 365 days of screening with ongoing chronic GVHD requiring systemic immunosuppresive therapy or subjects who have undergone transplantation with T-cell-depleted graft) 3. Clinically diagnosed with RSV infection with new onset or acute worsening (in case of pre-existing symptoms due to underlying respiratory disease) of at least one of the following symptoms: rhinorrhea/nasal congestion, sore throat, cough or dyspnea 4. Symptoms likely related to RSV infection have appeared within 5 days of screening and their severity requires initial or maintained hospitalization as judged by the investigator 5. Documented RSV infection in the upper respiratory tract (ie mid-turbinate nasal swam, nasopharyngeal swab, nasopharyngeal aspirate, nasal wash), as determined by local testing. Samples collected within 5 days of screening will be acceptable. If not yet available the assessments should be performed at the time of screening. 6. Subject has: a) diagnosis of RSV LRT disease OR b) diagnosis of RSV URT disease with high risk of progression to LRTI 7. Female subjects of childbearing potential (ie fertile, following menarche and until becoming post-menopausal unless permanently sterile) and fertile male subjects must agree to use highly effective contraceptive methods prior to study entry, for the duration of the study participation and for 3 months after the last dose of the study drug. 8. Female subjects of childbearing potential (exclusing postmenopausal women, sterilized, ovariectomized and hysterectomized women) must have a negative pregnancy test assessed locally at screening 9. Subject is capable to comprehend the informed consent document and provides a signed and dated Informed Consent Form 10. Subject must be willing and able (according to the investigator) to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: 1. Subject has clinically significant bacteremia or fungemia within 7 days of screening for which adequate treatment has not been completed at screening as determined by the investigator 2. Subject has clinically significant bacterial, fungal or viral pneumonia (other than the current RSV episode) within 15 days of screening that has not been adequately treated, as determined by the investigator 3. Subject is known to be HIV positive 4. Subject presents evidence of shock requiring ICU monitoring and/or vasopressor treatment 5. Subject requires or is expected to require invasive mechanical ventilation or intensive non-invasive respiratory support (CPAP, BiPAP, HFOT). Standard oxygen supplementation up to 6l/minute is permitted provided it can be interrupted for the duration of the study drug administration 6. Subject has been/is being treated with any of the following - any investigational antiviral medication or investigational biological within 5 half lives of screening - any investigational inhaled treatment within 5 half lives of screening - any monoclonal anti-RSV antibodies within 4 months or 5 half lives of screening (whichever is longer) - any investigational vaccine after HSCT - Aerosolized ribavirin within 3 days of screening or needing to initiate or continue this treatment 7. Subject is pregnant or breastfeeding 8. Subject has history of drug or alcohol abuse within 5 years of screening 9. Subject has concurrent life-threatening disease with life expectancy of less than 1 month 10. Subject has significant underlying lung disease that confounds the assessment of the RSV episode or any condition that, in the opinion of the investigator, would prevent full participation in this study or would interfere with the evaluation of any study endpoints 11. Subject was previously enrolled in a clinical study of ALX-0171 (including the current study ALX0171-C204) 12. Subject has a known hypersensitivity to the study drug or any excipient of the study drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is to evaluate the antiviral effect and safety of inhaled ALX-0171 in adults diagnosed with RSV respiratory tract infection after HSCT;Secondary Objective: The secondary objectives of the trial are: assess the clinical activity, PK, virology and immunogenecity of inhaled ALX-0171 in adults diagnosed with RSC respiratory tract infection after HSCT;Primary end point(s): Time-weighted average change from baseline to day 7 in log RSV nasal viral load (as measured by quantative reverse transcriptase polymerase chain reaction);Timepoint(s) of evaluation of this end point: Baseline Day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - The safety profile of ALX-0171 (as assessed by AEs, physical examination, clinical laboratory assessments, vital signs and oxygen saturation) - Nasal RSV load parameters over time, including time to undetectable shelding - Clinical stabilization, defined as respiratory rate 92% on room air for at least 12 hours, by Day 7 and up to EOS visit for subjects with LRTI at baseline - Percentage of subjects needing any supplemental oxygen therapy and percentage of subjects needing >2 l/minute oxygen supplementation through Day 7 and up to EOS visit - Number of day without oxygen or without oxygen supplementation at levels <= 2L/minute through Day7 and up to EOS visit - Progression to LRTI disease in subjects presenting with URTI at baseline by Day 7 and up to EOS visit. Progression to LRTI will be conducted by the investigator based on standard of care clinical, radiological and laboratory assessments - The PK parameters of ALX-0171 (serum concentrations of ALX-0171, area under the curve, Cmax, Tmax) - ADA serum concentrations over time;Timepoint(s) of evaluation of this end point: Day 1 to Day 42 | — |
Countries
Australia, Belgium, Brazil, France, Germany, Italy, Spain, Turkey, United States
Contacts
Public ContactClinical Trial Team
Ablynx NV
Outcome results
None listed