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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02325791




Registration number
NCT02325791
Ethics application status
Date submitted
21/12/2014
Date registered
25/12/2014
Date last updated
6/11/2018

Titles & IDs
Public title
Study to Evaluate the Efficacy and Safety of Suptavumab (REGN2222) for the Prevention of Medically Attended RSV (Respiratory Syncytial Virus) Infection in Preterm Infants
Scientific title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of a Human Monoclonal Antibody, REGN2222, for the Prevention of Medically Attended RSV Infection in Preterm Infants
Secondary ID [1] 0 0
R2222-RSV-1332
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Suptavumab 30 mg/kg
Treatment: Drugs - Placebo Matched to Suptavumab
Treatment: Drugs - Suptavumab 30 mg/kg- 1 Dose
Treatment: Drugs - Suptavumab 30 mg/kg - 2 Doses

Experimental: Part A: Suptavumab 30 mg/kg -

Experimental: Part B: Placebo Matched to Suptavumab -

Experimental: Part B: Suptavumab 30 mg/kg- 1 Dose -

Experimental: Part B: Suptavumab 30 mg/kg - 2 Doses -


Treatment: Drugs: Suptavumab 30 mg/kg
Participants received single dose of suptavumab 30 milligram per kilogram (mg/kg) intramuscularly (IM) on Day 1.

Treatment: Drugs: Placebo Matched to Suptavumab
Participants received 2 IM doses of placebo matched to suptavumab: the first dose on Day 1 and the second dose on Day 57.

Treatment: Drugs: Suptavumab 30 mg/kg- 1 Dose
Participants received single dose of suptavumab 30 mg/kg IM on Day 1 and single dose of placebo matched to suptavumab on Day 57.

Treatment: Drugs: Suptavumab 30 mg/kg - 2 Doses
Participants received 2 doses of suptavumab 30 mg/kg IM: the first dose on Day 1 and the second dose on Day 57.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part A: Serum Concentration of Suptavumab Over Time
Timepoint [1] 0 0
Day 1 through Day 150
Primary outcome [2] 0 0
Part B: Percentage of Participants With Medically Attended Respiratory Syncytial Virus (RSV) Infection (Hospitalization or Outpatient Visit With Lower Respiratory Tract Infection [LRTI]) Up to Day 150
Timepoint [2] 0 0
From first study drug administration up to Day 150
Secondary outcome [1] 0 0
Part A: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
Baseline through Day 150
Secondary outcome [2] 0 0
Part B: Serum Concentration of Suptavumab
Timepoint [2] 0 0
Day 29, 57, 85, 113 and Day 150 Post-dose
Secondary outcome [3] 0 0
Part B: Number of Participants With At Least One Positive Anti-Drug Antibody (ADA) Assay
Timepoint [3] 0 0
Day 1 through Day 150
Secondary outcome [4] 0 0
Part B: Percentage of Participants Hospitalized With Medically Attended RSV Infection or Outpatient Visit Lower Respiratory Tract Infection (LRTI) or Upper Respiratory Tract Infection (URTI) Up to Day 150
Timepoint [4] 0 0
From the first study drug administration up to Day 150

Eligibility
Key inclusion criteria
Key

1. Preterm, otherwise healthy male or female infant who is =6 months of age at the time of the first dose (i.e., infant must be treated on or before their 6 month birthday)
2. Gestational age is =35 weeks, 6 days at birth
3. Parent(s) or legal guardian(s) of the infant is able to understand the study requirements and willing to provide informed consent

Key
Minimum age
No limit
Maximum age
6 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Eligible, recommended and have access to receive palivizumab per AAP or other local guidelines, standard practice, or by their healthcare provider
2. History of CLD defined as requirement of supplemental oxygen for 28 days after birth
3. Known hemodynamically significant congenital heart disease
4. Known immunodeficiency, neuromuscular disease, or congenital abnormalities of the airway
5. Known renal or hepatic dysfunction
6. Major congenital malformations, including congenital cleft palate, cytogenetic abnormalities, or serious chronic disorders
7. Known or suspected impairment of immunological functions or autoimmune diseases
8. History of anaphylaxis
9. Previously received palivizumab or any other investigational RSV prophylaxis or vaccine product
10. Previous reaction to IV immunoglobulin, blood products or other foreign proteins, including vaccines and monoclonal antibodies

Note: Other inclusion and exclusion criteria apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/07/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/09/2017
Sample size
Target
Accrual to date
Final
1177
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 0 0
Regeneron Study Site - Hobart
Recruitment postcode(s) [1] 0 0
- Hobart
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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Arkansas
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California
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Connecticut
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Idaho
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Illinois
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Indiana
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Kentucky
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Maryland
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Wisconsin
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Munich
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Poole
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Reading
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Sheffield
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Stockton on Tees

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Regeneron Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trial Management
Address 0 0
Regeneron Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

TypeOther DetailsAttachment
Study protocol https://cdn.clinicaltrials.gov/large-docs/91/NCT02325791/Prot_000.pdf
Statistical analysis plan Statistical Analysis Plan: Part A https://cdn.clinicaltrials.gov/large-docs/91/NCT02325791/SAP_001.pdf
Statistical analysis plan Statistical Analysis Plan: Part B https://cdn.clinicaltrials.gov/large-docs/91/NCT02325791/SAP_002.pdf
Study protocol https://cdn.clinicaltrials.gov/large-docs/91/NCT02325791/Prot_000.pdf
Statistical analysis plan Statistical Analysis Plan: Part A https://cdn.clinicaltrials.gov/large-docs/91/NCT02325791/SAP_001.pdf
Statistical analysis plan Statistical Analysis Plan: Part B https://cdn.clinicaltrials.gov/large-docs/91/NCT02325791/SAP_002.pdf
Study protocol https://cdn.clinicaltrials.gov/large-docs/91/NCT02325791/Prot_000.pdf
Statistical analysis plan Statistical Analysis Plan: Part A https://cdn.clinicaltrials.gov/large-docs/91/NCT02325791/SAP_001.pdf
Statistical analysis plan Statistical Analysis Plan: Part B https://cdn.clinicaltrials.gov/large-docs/91/NCT02325791/SAP_002.pdf



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02325791