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

NCT03028909 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: D6000C00003
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Influenza - Type A Strains

Keywords

Influenza A; MEDI8852

Outcome Measures

Primary Outcomes (4)

• Evaluation of efficacy as defined as time to normalization of respiratory function.

  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.

  Through Day 14

• The occurence of Adverse Events

  Occurrence of adverse events.

  Through Day 28

• The occurence of Serious Adverse Events

  Occurrence of serious adverse events.

  Through Study Day 60

• The occurence of Adverse Events of Special Interest (AESIs)

  Occurrence of Adverse Events of Special Interest.

  Through Day 60

Secondary Outcomes (12)

• Assessment of the effect of MEDI8852 in reducing severity of clinical status.

  Through Day 7

• Evaluation of time to hospital discharge.

  Through Day 60

• Quantitation of influenza viral shedding by qRT-PCR.

  Through Day 60

• Evaluation of serum concentrations and PK of MEDI8852.

  Through Day 60

• Evaluation of serum ADA responses in serum through Day 60.

  Through Day 60

Study Arms (3)

Oseltamivir + low dose MEDI8852

EXPERIMENTAL

Low Dose of MEDI8852 + Oseltamivir will be studied

Drug: Oseltamivir; Drug: MEDI8852

Oseltamivir + high dose MEDI8852

EXPERIMENTAL

High dose of MEDI8852 + Oseltamivir will be studied.

Drug: Oseltamivir; Drug: MEDI8852

Oseltamivir + Placebo

ACTIVE COMPARATOR

Oseltamivir in conjunction with placebo will be studied.

Drug: Oseltamivir; Drug: Placebo

Interventions

Oseltamivir DRUG

Standard of care for influenza caused by Type A strains

Also known as: Tamiflu

Oseltamivir + Placebo; Oseltamivir + high dose MEDI8852; Oseltamivir + low dose MEDI8852

MEDI8852 DRUG

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

Oseltamivir + high dose MEDI8852; Oseltamivir + low dose MEDI8852

Placebo DRUG

Salt-water solution containing no active ingredients.

Oseltamivir + Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MedImmune LLC: lead

MeSH Terms

Interventions

Oseltamivir; MEDI8852

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: January 23, 2017
• Study Start: July 24, 2017
• Primary Completion: July 26, 2019
• Study Completion: July 26, 2019
• Last Updated: March 14, 2019

Record last verified: 2017-04