A Phase I/II Multicentre Study in Otherwise Healthy Infants and Toddlers Hospitalised For and Diagnosed With RSV Lower Respiratory Tract Infection to Evaluate the Safety, Tolerability, and Clinical Activity of ALX-0171.

• Conditions: Respiratory Syncytial Virus Lower Respiratory Tract Infection; MedDRA version: 18.1Level: PTClassification code 10061603Term: Respiratory syncytial virus infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2014-002841-23-BG
• Lead Sponsor: Ablynx NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-10
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

1. Subject is a male or female infant or toddler, aged 5 months to < 24 months for the open-label lead-in, Part A, or 3 months to < 24 months for the double-blind part of the study, Part B. Upon implementation of a positive DMC recommendation, subjects may be aged 28 days to < 24 months in Part B. For the expansion cohort, Part C, the subject's age must be 28 days to < 5 months.
2. Subject weighs at least 3.5 kg.
3. Subject is otherwise healthy, but hospitalised for and clinically diagnosed with RSV LRTI (bronchiolitis or broncho-pneumonia), i.e., showing typical clinical signs and symptoms such as tachypnoea, wheezing, cough, crackles, use of accessory muscles, and/or nasal flaring.
4. Subject has appearance of symptoms that are likely related to RSV infection within = 7 days at the time of screening, based on the Investigator's judgement.
5. Subject has a positive RSV diagnostic test.
6. Subject is expected to have to stay in the hospital for at least 24 hours (according to the Investigator’s judgement at screening).
7. Subject has normal psychomotor development (according to the Investigator’s judgement at screening).
8. Subject’s gestational age was > 37 weeks.
9. Parent(s)/legal guardian(s) are able and willing to provide written informed consent.
10. The subject and parent(s)/legal guardian(s) are able and willing to comply with the study protocol.

Are the trial subjects under 18? yes
Number of subjects for this age range: 53
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

Exclusion Criteria

1. Subject has history of wheezing (i.e., >3 previous episodes of wheezing), as reported by the parent(s)/legal guardian(s), or according to the Investigator’s judgement at screening.
2. Subject is known to have significant comorbidities, including genetic disorders (e.g., trisomy 21, cystic fibrosis), cardiopulmonary diseases (e.g., haemodynamically significant congenital heart disease, bronchopulmonary dysplasia), any hereditary or acquired metabolic (bone) diseases, haematological or other malignancy, or is known to be human immunodeficiency virus (HIV) positive.
3. Subject is known to be immunocompromised.
4. Subject has any presence of active severe atopic dermatitis requiring daily use of topical anti-inflamatory (corticosteroid or equivalent).
5. Subject has any physician-confirmed food allergy.
6. Subject is suspected of having a clinically relevant infection other than RSV.
7. Subject received mechanical ventilation or long-term respiratory support in the past 4 weeks prior to screening.
8. Subject has significant oral and/or maxillofacial malformations.
9. Subject is critically ill and/or is expected to require invasive mechanical ventilation or noninvasive respiratory support (e.g., continuous or bilevel positive airway pressure, or high flow humidified nasal oxygen) within 24 hours (according to the Investigator’s judgement at screening), with the exception of O2 supplementation via nasal cannula, simple face mask, or headbox.
10. Subject has received 1 or more doses of palivizumab at any time prior to screening, or has received treatment with any antiviral therapy for RSV (e.g., ribavirin or i.v. immunoglobulin) within 1 month prior to screening. Subjects planned to receive palivizumab treatment or other RSV prophylaxis should not be included in the study.
11. Subject is being treatied with corticosteroids and requires continued corticosteroid therapy.
12. Subject is being treated with antibiotics and needs continued antibiotic therapy. Note that subjects receiving antibiotics at screening will not be excluded if the antibiotics can be safely stopped according to the Investigator’s judgement. The initiation of antibiotic therapy during the study is allowed.
13. Subject is currently participating in any investigational study, or has previously participated in study ALX0171-C104.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified