A Study to Evaluate Safety and Tolerability of IV or SC Dose of MEDI-545 in Patients With Systemic Lupus Erythematosus.

May 9, 2018 updated by: AstraZeneca

A Phase II, Multicenter, Open-Label, Dose-Escalation Study to Evaluate Safety and Tolerability of IV or SC Dose of MEDI-545, a Fully Human Monoclonal Antibody Directed Against Interferon Alpha Subtypes, in Japanese Patients Who Have Systemic Lupus Erythematosus (SLE)

The purpose of the study is to evaluate the safety and tolerability of MEDI-545 in Japanese adult SLE patients. This will be done by collecting the data from 3 cohorts of IV doses and 1 cohort of SC doses.

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.

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.
30

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

  • Japan
      • Chiba-shi, Japan, 260-8712
        • Research Site
      • Fukuoka-shi, Japan, 810-8563
        • Research Site
      • Kanazawa-shi, Japan, 920-8650
        • Research Site
      • Kawagoe-shi, Japan, 350-8550
        • Research Site
      • Kitakyushu-shi, Japan, 807-8555
        • Research Site
      • Sapporo-shi, Japan, 060-8638
        • Research Site
      • Shinjuku-ku, Japan, 160-8582
        • 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

20 years to 130 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients must have previously met ≥4 of the 11 revised ACR criteria
  • Have positive antinuclear antibody test (ANA) at ≥1:80 serum dilute 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

Exclusion Criteria:

  • Have received prednisone >20 mg/day (or an equivalent dose of another oral corticosteroid) within 14 days before Visit 2 (Day 1)

  • Have received the following medications within 28 days before Visit 2 (Day 1):

    • Systemic cyclophosphamide at any dose
    • Cyclosporine at any dose
    • Tacrolimus at any dose
    • Thalidomide at any dose
    • Mycophenolate mofetil >2 g/day
    • Methotrexate >15 mg/week
    • Azathioprine >2 mg/kg/day
  • Women who have a positive pregnancy test (serum hCG) at Visit 1

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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.
Experimental: MEDI-545 1.0 mg/kg
Cohort 1
Drug: MEDI-545

Stage I: MEDI-545 1.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses.

Stage II: MEDI-545 1.0 mg/kg IV once every 2 weeks for a total of 79 doses.

Drug: MEDI-545

Stage I: MEDI-545 3.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses.

Stage II: MEDI-545 3.0 mg/kg IV once every 2 weeks for a total of 79 doses

Drug: MEDI-545

Stage I: MEDI-545 10.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses.

Stage II: MEDI-545 10.0 mg/kg IV once every 2 weeks for a total of 79 doses.

Drug: MEDI-545

Stage I: MEDI-545 100 mg SC, on Day 1 and weekly or once every 2 weeks from Day 29, for a total of 14 doses.

Stage II: MEDI-545 100 mg SC once every 2 weeks for a total of 79 doses.

Drug: MEDI-545

Stage I: MEDI-545 1,200 mg IV once every 4 weeks from Day 1 for a total of 8 doses.

Stage II: MEDI-545 1,200 mg IV once every 4 weeks for a total of 40 doses
Experimental: MEDI-545 3.0 mg/kg
Cohort 2
Drug: MEDI-545

Stage I: MEDI-545 1.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses.

Stage II: MEDI-545 1.0 mg/kg IV once every 2 weeks for a total of 79 doses.

Drug: MEDI-545

Stage I: MEDI-545 3.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses.

Stage II: MEDI-545 3.0 mg/kg IV once every 2 weeks for a total of 79 doses

Drug: MEDI-545

Stage I: MEDI-545 10.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses.

Stage II: MEDI-545 10.0 mg/kg IV once every 2 weeks for a total of 79 doses.

Drug: MEDI-545

Stage I: MEDI-545 100 mg SC, on Day 1 and weekly or once every 2 weeks from Day 29, for a total of 14 doses.

Stage II: MEDI-545 100 mg SC once every 2 weeks for a total of 79 doses.

Drug: MEDI-545

Stage I: MEDI-545 1,200 mg IV once every 4 weeks from Day 1 for a total of 8 doses.

Stage II: MEDI-545 1,200 mg IV once every 4 weeks for a total of 40 doses
Experimental: MEDI-545 10.0 mg/kg
Cohort 3
Drug: MEDI-545

Stage I: MEDI-545 1.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses.

Stage II: MEDI-545 1.0 mg/kg IV once every 2 weeks for a total of 79 doses.

Drug: MEDI-545

Stage I: MEDI-545 3.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses.

Stage II: MEDI-545 3.0 mg/kg IV once every 2 weeks for a total of 79 doses

Drug: MEDI-545

Stage I: MEDI-545 10.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses.

Stage II: MEDI-545 10.0 mg/kg IV once every 2 weeks for a total of 79 doses.

Drug: MEDI-545

Stage I: MEDI-545 100 mg SC, on Day 1 and weekly or once every 2 weeks from Day 29, for a total of 14 doses.

Stage II: MEDI-545 100 mg SC once every 2 weeks for a total of 79 doses.

Drug: MEDI-545

Stage I: MEDI-545 1,200 mg IV once every 4 weeks from Day 1 for a total of 8 doses.

Stage II: MEDI-545 1,200 mg IV once every 4 weeks for a total of 40 doses
Experimental: MEDI-545 100 mg
Cohort 4
Drug: MEDI-545

Stage I: MEDI-545 1.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses.

Stage II: MEDI-545 1.0 mg/kg IV once every 2 weeks for a total of 79 doses.

Drug: MEDI-545

Stage I: MEDI-545 3.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses.

Stage II: MEDI-545 3.0 mg/kg IV once every 2 weeks for a total of 79 doses

Drug: MEDI-545

Stage I: MEDI-545 10.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses.

Stage II: MEDI-545 10.0 mg/kg IV once every 2 weeks for a total of 79 doses.

Drug: MEDI-545

Stage I: MEDI-545 100 mg SC, on Day 1 and weekly or once every 2 weeks from Day 29, for a total of 14 doses.

Stage II: MEDI-545 100 mg SC once every 2 weeks for a total of 79 doses.

Drug: MEDI-545

Stage I: MEDI-545 1,200 mg IV once every 4 weeks from Day 1 for a total of 8 doses.

Stage II: MEDI-545 1,200 mg IV once every 4 weeks for a total of 40 doses
Experimental: MEDI-545 600 mg
Cohort 5
Drug: MEDI-545 600

Stage I: MEDI-545 600 mg IV once every 4 weeks from Day 1 for a total of 8 doses.

Stage II: MEDI-545 600 mg IV once every 4 weeks for a total of 40 doses.
Experimental: MEDI-545 1,200 mg
Cohort 6
Drug: MEDI-545

Stage I: MEDI-545 1.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses.

Stage II: MEDI-545 1.0 mg/kg IV once every 2 weeks for a total of 79 doses.

Drug: MEDI-545

Stage I: MEDI-545 3.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses.

Stage II: MEDI-545 3.0 mg/kg IV once every 2 weeks for a total of 79 doses

Drug: MEDI-545

Stage I: MEDI-545 10.0 mg/kg IV, on Day 1 and once every 2 weeks from Day 29, for a total of 14 doses.

Stage II: MEDI-545 10.0 mg/kg IV once every 2 weeks for a total of 79 doses.

Drug: MEDI-545

Stage I: MEDI-545 100 mg SC, on Day 1 and weekly or once every 2 weeks from Day 29, for a total of 14 doses.

Stage II: MEDI-545 100 mg SC once every 2 weeks for a total of 79 doses.

Drug: MEDI-545

Stage I: MEDI-545 1,200 mg IV once every 4 weeks from Day 1 for a total of 8 doses.

Stage II: MEDI-545 1,200 mg IV once every 4 weeks for a total of 40 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
Number of Participants With Each Category of Adverse Events in Stage I
Time Frame: Stage I (up to 1 year)
Stage I (up to 1 year)
Number of Participants in Each Category of Adverse Events (AE) in Stage II
Time Frame: Stage II (1 year to 3.5 years after first dose)
Stage II (1 year to 3.5 years after first dose)

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
Measure Description
Time Frame
Area Undre Curve (AUC) of MEDI-545 After First Dose in Stage I
Time Frame: After first dose in Stage I (0 upto 28 days)
After first dose in Stage I (0 upto 28 days)
AUC0-14 of MEDI-545 After First Dose in Stage I
Time Frame: After first dose in Stage I
Summary of area under the concentration-time curve from zero to Day 14.
After first dose in Stage I
Maximum Observed Concentration (Cmax) of MEDI-545 After First Dose in Stage I
Time Frame: After first dose in Stage I
After first dose in Stage I
Change From Baseline in 21-gene Signature Fold Change in Stage I
Time Frame: Stage I
21-gene signature fold change is pharmacodynamics (PD) parameter measuring expression of type I IFN-inducible gene.
Stage I
Number of Participants With Positive Anti-drug Antibody (ADA) During Stage I
Time Frame: Stage I
Stage I

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.
AstraZeneca

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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.
  • Principal Investigator: Tsutomu Takeuchi, Department of Internal Medicine School of Medicine Keio University
  • Principal Investigator: Yoshiya Tanaka, The University Hospital, University of Occupational and Environmental Health, Japan

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 (Actual)

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.
November 25, 2009

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.
November 7, 2012

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.
July 11, 2016

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).
December 11, 2009

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.
December 13, 2009

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.
December 15, 2009

Study Record Updates

Last Update Posted (Actual)

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.
November 19, 2018

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.
May 9, 2018

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.
March 1, 2018

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.
  • D2800C00001

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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