Evaluation of ALX-0171 in Japanese Children Hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection
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|ClinicalTrials.gov Identifier: NCT03418571|
Recruitment Status : Terminated (The Sponsor decided to discontinue ALX-0171 development (due to insufficient evidence of efficacy). As a result, the ALX0171-C203 study was early terminated.)
First Posted : February 1, 2018
Results First Posted : July 15, 2019
Last Update Posted : July 30, 2019
This was a randomized, double-blind, multicenter, Phase II study (NCT03418571) designed to support the selection of an optimal dose of inhaled ALX-0171 for further clinical development, taking ethnicity into consideration.
Based on the results of the Phase IIb dose-ranging study ALX0171-C201 (RESPIRE), the Sponsor decided to discontinue ALX-0171 development in infants and to early terminate the ALX0171-C203 study.
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Syncytial Virus Lower Respiratory Tract Infection||Biological: ALX-0171 1.5 mg/kg Other: Placebo||Phase 2|
Four dose levels were planned to be evaluated in four consecutive cohorts consisting of Japanese infants and young children aged 28 days to <2 years with a gestational age ≥33 weeks who were hospitalized for and diagnosed with respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI):
- Dose level 1: target dose of 1.5 mg/kg
- Dose level 2: target dose of 3.0 mg/kg
- Dose level 3: target dose of 6.0 mg/kg
- Dose level 4: target dose of 9.0 mg/kg
Each cohort was planned to consist of 15 subjects enrolled and randomly assigned to receive ALX-0171 or placebo, in an allocation ratio of 4:1 (N = 12 active versus N = 3 placebo per cohort).
Due to early termination of the trial, only enrollment of Cohort 1 could be completed as planned. For Cohort 2, only 1 subject was screened but did not meet the eligibility criteria and was considered a screen failure. Therefore, data were not available for treatment groups ALX-0171 3.0 mg/kg, 6.0 mg/kg, and 9.0 mg/kg.
Of note, in line with applicable guidelines, an Independent Data Monitoring Committee (IDMC) was assigned to monitor the study. Upon completing of Cohort 1, the IDMC reviewed the available unblinded safety data and unanimously recommended to continue the study with no changes to the protocol.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-blind, Multicenter, Multiple-dose Study of ALX-0171 Versus Placebo Along With Standard of Care in Japanese Infants and Young Children Hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection|
|Actual Study Start Date :||March 1, 2018|
|Actual Primary Completion Date :||October 24, 2018|
|Actual Study Completion Date :||October 24, 2018|
|Experimental: ALX-0171 1.5 mg/kg||
Biological: ALX-0171 1.5 mg/kg
ALX-0171 1.5 mg/kg was administered via a single inhalation once daily for 3 consecutive days.
|Placebo Comparator: Placebo||
Placebo was administered via a single inhalation once daily for 3 consecutive days.
- Safety and Tolerability of Inhaled ALX-0171 1.5 mg/kg as Measured by the Number of Subjects With at Least 1 Serious or Non-Serious Treatment-emergent Adverse Event (TEAE). [ Time Frame: From the subject's first study drug administration until completion of the subject's last visit, an average of 4 weeks ]Number of subjects reported with at least 1 serious or non-serious TEAEs in the ALX-0171 1.5 mg/kg treatment group and placebo treatment group.
- Safety and Tolerability of Inhaled ALX-0171 1.5 mg/kg as Measured by the Number of Serious and Non-serious TEAEs. [ Time Frame: From the subject's first study drug administration until completion of the subject's last visit, an average of 4 weeks ]Number of serious and non-serious TEAEs reported in the ALX-0171 1.5 mg/kg treatment group and placebo treatment group.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03418571
|Investigator site 1|
|Investigator site 2|
|Study Director:||Medical Monitor||Ablynx NV|