A Study to Evaluate Safety and Tolerability of Subcutaneous Doses of MEDI-545 in Subjects With Lupus

August 5, 2016 updated by: MedImmune LLC

A Phase 2A , Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Dose Study to Evaluate the Safety and Tolerability of Multiple Subcutaneous Doses of MEDI-545, A Fully Human Anti-Interferon-Alpha Monoclonal Antibody, In Subjects With Systemic Lupus Erythematosus

The primary objective of this study is to evaluate the safety and tolerability of multiple doses of MEDI-545 in subjects with moderately to severely active Lupus.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The primary objective of this study is to evaluate the safety and tolerability of multiple SC doses of MEDI-545 in subjects ≥ 18 years of age with moderately to severely active SLE despite standard of care.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
87

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Research Site
    • California
      • Huntington Beach, California, United States, 92646
        • Research Site
      • Upland, California, United States, 91786
        • Research Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80910
        • Research Site
    • Connecticut
      • Farmington, Connecticut, United States, 06030-5353
        • Research Site
    • Florida
      • Clearwater, Florida, United States, 33765-2616
        • Research Site
      • Ocala, Florida, United States, 34474
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Research Site
      • Decatur, Georgia, United States, 30033
        • Research Site
      • Marrietta, Georgia, United States, 30060
        • Research Site
      • West Fayetteville, Georgia, United States, 30269
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Research Site
    • Michigan
      • Lansing, Michigan, United States, 48910
        • Research Site
    • New York
      • Brooklyn, New York, United States, 10003
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Research Site
    • Oklahoma
      • Oklahoma, Oklahoma, United States, 73104
        • Research Site
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Research Site
      • Columbia, South Carolina, United States, 29204
        • Research Site
    • Texas
      • Houston, Texas, United States, 77004
        • Research Site
      • Sugarland, Texas, United States, 77479
        • Research Site
    • Washington
      • Seattle, Washington, United States, 98111
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female subjects ≥ 18 years at the time of the first dose of study drug;
  • Written informed consent and HIPAA authorization (applies to covered entities in the US only) obtained from the subject or subject's legal representative;
  • Meet at least 4 of the 11 revised ACR classification criteria for SLE
  • Have positive antinuclear antibody test (ANA) at ≥ 1:80 serum dilution documented in the past or at screening;
  • Have at least 1 system with a score of A or 2 systems with a score of B on the BILAG index at screening, or have a SELENA-SLEDAI score ≥ 6;
  • Treatment for SLE with antimalarials, oral prednisone or another systemic corticosteroid, mycophenolate mofetil, methotrexate, leflunomide, azathioprine, or dapsone;
  • Women, unless surgically sterile or at least 2 years post-menopausal, must use an effective method of avoiding pregnancy (including oral, injectable, transdermal, or implanted contraceptives, intrauterine device, diaphragm with spermicide, cervical cap, abstinence, or sterile sexual partner) in addition to the use of condoms (male or female condoms with spermicide) from screening through the end of the study. Cessation of birth control after this point should be discussed with a responsible physician. Men unless surgically sterile, must likewise practice 2 effective methods of birth control (condom with spermicide or abstinence) from Study Day 0 through the end of the study;
  • Ability to complete the study period, including the follow-up period through Study Day 168; and
  • Willing to forego other forms of experimental treatment during the study.

Exclusion Criteria:

  • Have received MEDI-545 within 120 days prior to screening;
  • History of allergy or reaction to any component of the study drug formulation;

  • Have received the following medications within 28 days before randomization:

    • Systemic cyclophosphamide at any dose
    • Cyclosporine at any dose
    • Thalidomide at any dose
    • Hydroxychloroquine > 600 mg/day
    • Mycophenolate mofetil > 3 g/day
    • Methotrexate > 25 mg/week
    • Azathioprine > 3 mg/kg/day

  • Have received fluctuating doses of the following within 28 days before randomization:

    • Antimalarials
    • Mycophenolate mofetil
    • Methotrexate
    • Leflunomide
    • Azathioprine
    • Dapsone
  • Have received Leflunomide > 20mg/day in the 6 months prior to Study Day 0;
  • Have received prednisone > 20 mg/day or in fluctuating doses within 14 days before randomization;
  • Have received fluctuating doses of non-steroidal anti-inflammatory drugs within 14 days before randomization;
  • Treatment with any investigational drug therapy within 28 days before randomization into the study, B cell-depleting therapies within 12 months before randomization, or biologic therapies within 30 days or 5 half-lives of the biologic agent, whichever is longer, before randomization into the study;
  • In the investigator's opinion, evidence of clinically significant active infection, including ongoing, chronic infection, within 28 days before randomization;
  • A history of severe viral infection as judged by the investigators, including severe infections of either cytomegalovirus or the herpes family such as disseminated herpes, herpes encephalitis, ophthalmic herpes;
  • Herpes zoster infection within 3 months before randomization;
  • Evidence of infection with hepatitis B or C virus, or human immunodeficiency virus (HIV)-1 or HIV-2, or active infection with hepatitis A, as determined by results of testing at screening
  • Vaccination with live attenuated viruses within 28 days before randomization;
  • Pregnancy (women, unless surgically sterile or at least 2 years post-menopausal, must have a negative serum pregnancy test within 28 days before receiving the study drug and a negative urine pregnancy test on days of study drug administration before receiving the study drug);
  • Breastfeeding or lactating women;
  • History of primary immunodeficiency;
  • History of alcohol or drug abuse < 1 year prior to randomization;
  • History of cancer (except basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy > 1 year prior to randomization);
  • History of active tuberculosis (TB) infection or newly positive TB skin test (defined as a reaction ≥ 10 mm in diameter if not on systemic immunosuppressive medication or ≥ 5 mm if on systemic immunosuppressive medication;
  • History of latent TB infection without completion of an appropriate course of treatment;
  • Elective surgery planned from the time of screening through Study Day 168;

  • At screening blood tests (within 28 days before randomization), any of the following:

    • AST > 2.5 x upper limit of the normal range (ULN), unless caused by SLE
    • ALT > 2.5 x ULN, unless caused by SLE
    • Creatinine > 4.0 mg/dL
    • Neutrophils < 1,500/mm3
    • Platelet count < 50,000/mm3
  • History of any disease, evidence of any current disease (other than SLE), any finding upon physical examination, or any laboratory abnormality that, in the opinion of the investigator or medical monitor, may compromise the safety of the subject in the study or confound the analysis of the study; or
  • Any employee of the research site who is involved with the conduct of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: 5
Placebo
Drug: Placebo
SC Placebo every week × 13 doses
Experimental: 1
MEDI-545
Drug: MEDI-545
100 mg once; SC Placebo × 12 doses on other weeks
Drug: MEDI-545
100 mg every 4 weeks × 4 doses; SC Placebo × 9 doses on other weeks
Drug: MEDI-545
100 mg every 2 weeks × 7 doses; SC Placebo × 6 doses on other weeks
Drug: MEDI-545
100 mg every week × 13 doses
Experimental: 2
MEDI-545
Drug: MEDI-545
100 mg once; SC Placebo × 12 doses on other weeks
Drug: MEDI-545
100 mg every 4 weeks × 4 doses; SC Placebo × 9 doses on other weeks
Drug: MEDI-545
100 mg every 2 weeks × 7 doses; SC Placebo × 6 doses on other weeks
Drug: MEDI-545
100 mg every week × 13 doses
Experimental: 3
MEDI-545
Drug: MEDI-545
100 mg once; SC Placebo × 12 doses on other weeks
Drug: MEDI-545
100 mg every 4 weeks × 4 doses; SC Placebo × 9 doses on other weeks
Drug: MEDI-545
100 mg every 2 weeks × 7 doses; SC Placebo × 6 doses on other weeks
Drug: MEDI-545
100 mg every week × 13 doses
Experimental: 4
MEDI-545
Drug: MEDI-545
100 mg once; SC Placebo × 12 doses on other weeks
Drug: MEDI-545
100 mg every 4 weeks × 4 doses; SC Placebo × 9 doses on other weeks
Drug: MEDI-545
100 mg every 2 weeks × 7 doses; SC Placebo × 6 doses on other weeks
Drug: MEDI-545
100 mg every week × 13 doses

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The safety and tolerability of MEDI-545 will be assessed primarily by summarizing treatment emergent AEs and SAEs and by assessing changes in viral cultures.
Time Frame: Immediately following the first administration of study drug through Study Day 168.
Immediately following the first administration of study drug through Study Day 168.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
A secondary endpoint of this study is to assess certain measures of disease activity including PK, and PD of SC doses of MEDI-545.
Time Frame: At Study Day 98
At Study Day 98

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MedImmune LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Warren Greth, M.D., MedImmune LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 9, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 9, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MI-CP179

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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