Primary ObjectivesPart A:To determine the pharmacokinetics (PK) of intramuscular (IM)administrations of REGN2222Part B:To demonstrate the efficacy of REGN2222 in preventing medicallyattended respiratory syncytial virus (RSV) infections (subjects…
ID
Source
Brief title
Condition
- Viral infectious disorders
- Neonatal respiratory disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Part A:
* Serum concentration of REGN2222 over time and other PK parameters
Part B:
* Proportion of subjects with a medically attended RSV infection
(hospitalization or outpatient LRTI) during the study period. A
medically attended RSV infection is defined as an infant with a positive RSV
test by RT-PCR with any of the following events:
* - Hospitalized (on the basis of the assessment of the admitting physician)
for RSV infection
* - Outpatient visit (ER, UC, or pediatric clinic [for either a sick or well
visit]) with RSV LRTI.
An RSV LRTI in an infant is defined as an RSV-proven respiratory
infection (ie, positive RSV RT-PCR test) with parent(s)/ guardian(s)
report of cough or difficulty breathing, and with 1 of the following
signs of LRTI, as assessed by a healthcare provider:
* - Lower chest wall indrawing
* - Hypoxemia (peripheral capillary oxygen saturation
<95% breathing room air)
* - Wheezing or crackles.
Secondary outcome
Secundary endpoints:
Part A:
* - Incidence and severity of treatment-emergent adverse events (TEAEs)
* - Presence and titer of anti-REGN2222 antibodies
Part B:
* - Proportion of subjects who have RSV-confirmed hospitalization, ER, UC, or
pediatric clinic visits (for upper or lower tract
infections) during the study period.
Exploratory endpoints:
- Total number of RSV-associated medical visits (hospital, ER, UC, or pediatric
visits) for each subject and associated treatments or
( see Page 11 of 110 Clinical Study Protocol R2222-RSV-1332.03EU, Regeneron
Pharmaceuticals, Inc. CONFIDENTIAL) procedures at these visits
- Total number of medical visits (hospital, ER, UC, or pediatric visits) for
each subject and associated treatments or procedures at
these visits, during the study period excluding the initial RSV-associated
medical visits.
- Number of RSV-confirmed hospitalizations
- Number of days with RSV-associated mechanical ventilation
- Number of days with RSV-associated supplemental oxygen
- Length of stay in hospital
- Number of missed days of work for parent(s) or guardian(s) associated with
each medically attended RSV event
Background summary
Respiratory syncytial (sin-SISH-uhl) virus, or RSV, is a respiratory virus that
infects the lungs and breathing passages. Healthy people usually experience
mild, cold-like symptoms and recover in a week or two. But RSV can be serious,
especially for premature infants, older adults and anyone with a weakened
immune system. Almost all children will have had an RSV infection by their
second birthday. RSV is spread through contact with droplets from the nose and
throat of infected people when they cough and sneeze. RSV can also spread
through dried respiratory secretions on bedclothes and similar items. RSV can
remain on hard surfaces for several hours and on skin for shorter amounts of
time.
There is no specific treatment for RSV infection. Antibiotics are not effective
treatments for viral illnesses such as RSV infection. Instead, physicians
treat the associated symptoms. Researchers are working on two different ways to
prevent RSV: vaccines and monoclonal antibodies.
Study objective
Primary Objectives
Part A:
To determine the pharmacokinetics (PK) of intramuscular (IM)
administrations of REGN2222
Part B:
To demonstrate the efficacy of REGN2222 in preventing medically
attended respiratory syncytial virus (RSV) infections (subjects with
either RSV-confirmed hospitalizations or outpatient lower
respiratory tract infection [LRTI])
Secondary Objectives
Part A:
To evaluate safety, tolerability, and immunogenicity of REGN2222
following IM administration
Part B:
To evaluate safety and tolerability of REGN2222
To demonstrate the efficacy of REGN2222 in reducing RSV-confirmed
hospitalizations, emergency room (ER), urgent care (UC), or pediatric clinic
visits
To assess monthly serum levels of different dosing regimens of REGN2222
To assess the immunogenicity of REGN2222
Exploratory Objectives *
To collect DNA for the prospective study of the association of host
biomarkers with RSV infection and severity
To summarize the effect of REGN2222 on RSV-confirmed
hospitalization, including the following:
- Number of days on RSV mechanical ventilation
- Number of days requiring supplemental oxygen
To assess the impact of REGN2222 on pharmacoeconomic
outcomes (number of medical visits for RSV infection, total number
of medical visits, associated medical interventions or treatments,
number of missed days of work by the parent[s] or guardian[s] in
association with each medically attended RSV event)
Study design
This is a Phase 3 study that will be conducted in 2 parts. Part A is an
open-label, 1-cohort, multicenter PK study. Subjects in Part A may enroll
anytime during the RSV season. Part B is a randomized, placebo-controlled,
3-arm, multicenter study. In Part B, the sponsor (Regeneron
Pharmaceuticals, Inc.) will provide permitted windows for prophylaxis of
subjects in each geographical area based on historic data on the timing and
duration of the RSV season. Study sites in the European Union (EU) region
will participate only in part B.
Intervention
Part A:
* 24 subjects will receive REGN2222 30 mg/kg (maximum 1 dose)
Part B:
* 505 subjects will receive REGN2222 30 mg/kg on Day 1
(maximum 1 dose) and placebo on Day 57 (maximum 1 dose)
* 505 subjects will receive REGN2222 30 mg/kg (Q8 weeks) on
Day 1 and Day 57 (maximum 2 doses)
* 505 subjects will received placebo on Day 1 and Day 57 (maximum
2 doses)
Study burden and risks
There are no identified risks for REGN2222 based on clinical experience to
date.
Old Saw Mill River Road 777
Tarrytown NY 10591
US
Old Saw Mill River Road 777
Tarrytown NY 10591
US
Listed location countries
Age
Inclusion criteria
1. Preterm, otherwise healthy male or female infant who has a
chronological age of *6 months of age at the time of the first dose (ie.,
infant must receive the first dose on or before the subject's 6 month
birthday)
2. Gestational age at birth is no more than 35 weeks, 6 days
3. Parent(s) or legal guardian(s) of the infant is able to understand the
study requirements, willing to provide informed consent, and legally able
to provide informed consent.
Exclusion criteria
- Eligible and recommended to receive palivizumab per AAP or other
local guidelines, standard practice, or by their healthcare provider
- Children in whom a single blood draw would exceed 1% of their
estimated total blood volume
- History of CLD defined as requirement of supplemental oxygen for 28
days after birth
- Known hemodynamically significant congenital heart disease
- Known immunodeficiency, neuromuscular disease, or congenital
abnormalities of the airway
- Previously received palivizumab, IV gamma globulin, or any other
investigational RSV prophylaxis or vaccine product
- Previous reaction to IV immunoglobulin, blood products or other
foreign proteins, such as vaccines and monoclonal antibodies, or any of
the components of the investigational product formulation
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR201500171496-NL |
| ClinicalTrials.gov | NCT02325791 |
| CCMO | NL54959.041.15 |