A Phase 2b Study to Evaluate the Efficacy and Safety of MEDI8852 in Adults who are Hospitalized with Influenza

• Register: EUCTR
• Last refreshed on: 3 April 2017
• Main ID: EUCTR2015-004276-29-ES
• Date of registration: 23/08/2016
• Prospective Registration: Yes
• Primary sponsor: MedImmune, LLC
• Public title: A Phase 2b Study to Evaluate the Efficacy and Safety of MEDI8852 in Adults who are Hospitalized with Influenza
• Scientific title: A Phase 2b, Randomized, Double-blind, Single-dose, Active-controlled, Dose Ranging Study to Evaluate the Efficacy and Safety of MEDI8852 in Adults who are Hospitalized with Influenza Caused by Type A Strains
• Date of first enrolment: 10/10/2016
• Target sample size: 450
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-004276-29
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Belgium, Bulgaria, Canada, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hungary, Israel, Italy, Latvia, Mexico, Netherlands, Poland, Romania, Russian Federation, South Africa, Spain, Sweden, Turkey, United States

Contacts

• Name: Information Center
• Affiliation: MedImmune, LLC

• Name: Information Center
• Affiliation: MedImmune, LLC

Key inclusion & exclusion criteria

Inclusion criteria:
1. Age 18 years or older at the time of screening.
2. Written informed consent and any locally required authorization
obtained from the subject/legal representative prior to performing any
protocol-related procedures, including screening evaluations.
3. Females of childbearing potential who are sexually active with a
nonsterilized male partner must have evidence of not being pregnant
upon enrollment and have a negative pregnancy test prior to
administration of investigational product.
4. Hospitalized = 72 hours prior to receipt of a positive diagnostic test
for influenza A; confirmed with positive rapid antigen test, or confirmed
with culture, polymerase chain reaction, or antigen testing at the study
site.
5. Onset of influenza symptoms = 144 hours (= 6 days) prior to
randomization.
6. Receiving supplemental oxygen.
7. Expected to participate in the study through Day 60.
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 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 270

Exclusion criteria:
1. Any condition that, in the opinion of the investigator, would interfere
with evaluation of study drugs or interpretation of subject safety or
study results.
2. Concurrent enrollment in another clinical study involving an
investigational treatment.
3. Hospitalized > 72 hours (> 3 days) prior to receipt of a positive
diagnostic test for influenza A.
4. Receipt of > 72 hours or > 6 doses of treatment with a neuraminidase (NA) inhibitor.
5. Receipt of any investigational antiviral medications within 30 days
prior to study drug dosing.
6. Previous receipt of an influenza mAb within past 100 days.
7. Pregnant or nursing female.
8. History of allergic disease or reactions likely to be exacerbated by any
components of the study drugs (MEDI8852 or oseltamivir).
9. Diagnosis of influenza B infection within 14 days prior to
randomization.
10. Employees of the sponsor, clinical study site, or any other individuals
involved with the conduct of the study, or immediate family members of
such individuals.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Virus Diseases [C02]

Patients hospitalized with influenza caused by Type A strains
MedDRA version: 19.0 Level: LLT Classification code 10022002 Term: Influenza A virus infection System Organ Class: 100000004862

Intervention(s)

Product Name: MEDI8852
Product Code: MEDI8852
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Not assigned
Current Sponsor code: MEDI8852
Other descriptive name: HUMAN IMMUNOGLOBULIN G
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Main Objective: 1. To evaluate the effect of MEDI8852 administered in conjunction with
oseltamivir and the effect of oseltamivir alone in reducing time to
normalization of respiratory function
2. To compare the safety and tolerability of a single intravenous(IV)
dose of MEDI8852 administered in conjunction with oseltamivir to the
safety and tolerability of oseltamivir alone

Primary end point(s): a. Time to normalization of respiratory function, defined as:
i. For subjects without underlying chronic lung disease and not on supplemental
oxygen prior to hospitalization, an oxygen saturation of = 95% for 24 hours on room air
ii. For subjects with underlying chronic lung disease or on supplemental
oxygen prior to hospitalization, a return to their baseline oxygen
saturation and/or supplemental oxygen requirements as recorded during
the 2 months prior to admission and not associated with a concurrent respiratory illness or the
onset of influenza symptoms for 24 hours

2. Safety of MEDI8852
Treatment-emergent serious adverse events (TESAEs) treatment-emergent adverse events (TEAEs) and treatmentemergent adverse events of special interest (TEAESIs)

Secondary Objective: To evaluate/determine: 1. the effect of MEDI8852 in reducing severity of clinical status
2. the effect of MEDI8852 in reducing time to clinical resolution of individual vital sign abnormalities
3.the effect of MEDI8852 in reducing NEWS
4.the effect of MEDI8852 in reducing time to hospital discharge
5.the effect of MEDI8852 in reducing time to ICU discharge
6.the effect of MEDI8852 in reducing the duration of mechanical ventilation
7.the effect of MEDI8852 in reducing the rates of ICU admission from the general ward
8.the effect of MEDI8852 on all-cause mortality
9.the effect of MEDI8852 on all-cause hospital re-admission rates during the study
10.the effect of MEDI8852 in reducing the duration and quantity of viral shedding by by quantitative reverse transcriptase (qRT-PCR) over time
11. To evaluate the serum concentration and PK of MEDI8852
12. To evaluate the serum ADA of MEDI8852

Timepoint(s) of evaluation of this end point: 1. Efficacy of MEDI8852.
Respiratory function will be followed through Day 14.
2. Safety of MEDI8852
a. TEAEs through Day 28
b. TESAEs and TEAESIs through Day 60

Secondary Outcome(s)

Secondary end point(s): 1. Ordinal outcome of clinical status
2. Time to clinical resolution of individual vital signs abnormalities, including temperature, respiration rate, heart rate, and blood pressure
3. Change in NEWS from baseline to Day 3
4. Time to hospital discharge
5. Time to ICU discharge
6. Duration of mechanical ventilation
7. Rate of ICU admission from the general ward
8. All-cause mortality
9. Rate of all-cause re-admission during the study
10. Quantification of influenza viral shedding over time by qRT-PCR
11. MEDI8852 serum concentration and PK parameters
12. MEDI8852 ADA response in serum

Timepoint(s) of evaluation of this end point: 1. Day 7
2-11. Followed through Day 60.

Secondary ID(s)

2015-004276-29-LV

D6000C00003

Source(s) of Monetary Support

MedImmune, LLC