Dose Ranging Study to Evaluate the Efficacy and Safety of MEDI8852 in Adults Who Are Hospitalized With Type A Influenza.

NCT ID: NCT03028909

Last Updated: 2019-03-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-24
• Study Completion Date: 2019-07-26

Brief Summary

The purposes of this study are to determine if MEDI8852 administered with standard of care (oseltamivir) will reduce the time to normalization of respiratory function for adults who are hospitalized with influenza caused by Type A strains and to determine if MEDI8852 has an acceptable safety profile in adults who are hospitalized with influenza caused by Type A strains.

Detailed Description

The MEDI8852 phase 2b study will evaluate the efficacy and safety of a single intravenous (IV) dose of MEDI8852 or placebo administered in conjunction with oseltamivir in adult subjects who are hospitalized with influenza caused by Type A strains. Approximately 450 subjects will be enrolled at study centers in North America, Europe, and other regions.

Conditions

Influenza - Type A Strains

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Oseltamivir + low dose MEDI8852

Low Dose of MEDI8852 + Oseltamivir will be studied

Group Type: EXPERIMENTAL

Oseltamivir

Intervention Type: DRUG

Standard of care for influenza caused by Type A strains

MEDI8852

Intervention Type: DRUG

MEDI8852 is a human IgG1 kappa monoclonal antibody (mAb) administered via infusion.

Oseltamivir + high dose MEDI8852

High dose of MEDI8852 + Oseltamivir will be studied.

Group Type: EXPERIMENTAL

Oseltamivir

Intervention Type: DRUG

Standard of care for influenza caused by Type A strains

MEDI8852

Intervention Type: DRUG

MEDI8852 is a human IgG1 kappa monoclonal antibody (mAb) administered via infusion.

Oseltamivir + Placebo

Oseltamivir in conjunction with placebo will be studied.

Group Type: ACTIVE_COMPARATOR

Oseltamivir

Intervention Type: DRUG

Standard of care for influenza caused by Type A strains

Placebo

Intervention Type: DRUG

Salt-water solution containing no active ingredients.

Interventions

Oseltamivir

Standard of care for influenza caused by Type A strains

Intervention Type: DRUG

MEDI8852

MEDI8852 is a human IgG1 kappa monoclonal antibody (mAb) administered via infusion.

Intervention Type: DRUG

Placebo

Salt-water solution containing no active ingredients.

Intervention Type: DRUG

Other Intervention Names

Tamiflu

Eligibility Criteria

Inclusion Criteria

Age 18 years or older at the time of screening. Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act [HIPAA] in the United States, Data Privacy Directive in Europe) obtained from the subject/legal representative prior to performing any protocol related procedures, including screening evaluations.

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. Females of childbearing potential are defined as those who are not surgically sterile (ie, bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy), premenarchal, or postmenopausal (defined as 12 months with no menses without an alternative medical cause). Hospitalized ≤ 72 hours prior to receipt of a positive diagnostic test for influenza A; confirmed with positive rapid antigen test (supplied or approved by the sponsor), or confirmed with culture, polymerase chain reaction, or antigen testing at the study site. Onset of influenza symptoms ≤ 144 hours (≤ 6 days) prior to randomization. Receiving supplemental oxygen. Expected to participate in the study through Day 60.

Exclusion Criteria

• Any condition that, in the opinion of the investigator, would interfere with evaluation of study drugs or interpretation of subject safety or study results.
• Concurrent enrollment in another clinical study involving an investigational treatment. -Hospitalized > 72 hours (> 3 days) prior to receipt of a positive diagnostic test for influenza A.
• Receipt of > 72 hours or > 6 doses of treatment with a neuraminidase (NA) inhibitor. -Receipt of any investigational antiviral medications within 30 days prior to study drug dosing.
• Previous receipt of an influenza mAb within past 100 days.
• Pregnant or nursing female.
• History of allergic disease or reactions likely to be exacerbated by any components of the study drugs (MEDI8852 or oseltamivir).
• Diagnosis of influenza B infection within 14 days prior to randomization.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MedImmune LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

D6000C00003

Identifier Type: -

Identifier Source: org_study_id