Efficacy and safety of ALX-0171 in adults hematopoietic stem cell transplant (HST) recipients who present with an respiratory syncytial virus (RSV) infectio

Phase 1

Conditions: Respiratory Syncytial Virus Infection
MedDRA version: 20.1Level: PTClassification code 10061603Term: Respiratory syncytial virus infectionSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2017-003356-23-BE

Lead Sponsor: Ablynx NV

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 75

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>Day 7

Secondary Outcome Measures

Name	Time	Method

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