An Open-label Study to Evaluate the Long-term Safety of MEDI-546, for the Treatment of SLE, in Adults

July 11, 2019 updated by: MedImmune LLC

A Phase 2, Open-label Extension Study to Evaluate Long-term Safety of MEDI-546 in Adults With Systemic Lupus Erythematosus

The purpose of this study is to evaluate the long-term safety of anifrolumab (MEDI-546) in adults with moderate to severe active systemic lupus erythematosus (SLE).

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

This is an open-label extension study to evaluate long-term safety and tolerability of intravenous (IV) anifrolumab in adult participants with moderately-to-severely active SLE. Participants must have completed the qualifying Phase 2 study and meet this study criteria in order to be eligible.

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.
218

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

  • Brazil
      • Rio de Janeiro, Brazil, 22040-042
        • Research Site
      • Sao Paulo, Brazil, 04032-060
        • Research Site
  • Bulgaria
      • Plovdiv, Bulgaria, 4002
        • Research Site
      • Sofia, Bulgaria, 1431
        • Research Site
  • Colombia
      • Barranquilla, Colombia
        • Research Site
      • Bogota, Colombia
        • Research Site
      • Bucaramanga, Colombia
        • Research Site
      • Chia, Colombia
        • Research Site
      • Medellin, Colombia
        • Research Site
  • Czechia
      • Brno, Czechia
        • Research Site
      • Praha 2, Czechia
        • Research Site
  • Hungary
      • Debrecen, Hungary
        • Research Site
  • Korea, Republic of
      • Gwangju, Korea, Republic of
        • Research Site
      • Seodaemun-gu, Korea, Republic of
        • Research Site
      • Suwon-si, Korea, Republic of, 16499
        • Research Site
  • Mexico
      • Guadalajara, Mexico
        • Research Site
      • Leon, Mexico
        • Research Site
      • Mexico, Mexico
        • Research Site
      • Toluca, Mexico
        • Research Site
  • Peru
      • Arequipa, Peru
        • Research Site
      • Lima, Peru
        • Research Site
      • Lima, Peru, 15033
        • Research Site
  • Poland
      • Bialystok, Poland, 15-297
        • Research Site
      • Krakow, Poland, 31-011
        • Research Site
      • Nadarzyn, Poland, 05-830
        • Research Site
      • Poznan, Poland, 61-397
        • Research Site
  • Romania
      • Iasi, Romania, 700661
        • Research Site
  • Taiwan
      • Chiayi, Taiwan, 622
        • Research Site
      • Zhongzheng District, Taiwan
        • Research Site
  • Ukraine
      • Donetsk, Ukraine
        • Research Site
      • Kyiv, Ukraine
        • Research Site
      • Ternopil, Ukraine
        • Research Site
      • Vinnitsya, Ukraine, 21029
        • Research Site
      • Vinnytsia, Ukraine, 21018
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Research Site
    • California
      • La Palma, California, United States, 90623
        • Research Site
      • Long Beach, California, United States, 90806
        • Research Site
      • Los Angeles, California, United States, 90095-1670
        • Research Site
      • Palm Desert, California, United States, 92260
        • Research Site
      • Upland, California, United States, 91786
        • Research Site
    • Florida
      • Ocala, Florida, United States, 34474
        • Research Site
      • Orlando, Florida, United States, 32806
        • Research Site
      • Tampa, Florida, United States, 33614
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30281
        • Research Site
      • Stockbridge, Georgia, United States, 30281
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Research Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Research Site
    • New Mexico
      • Las Cruces, New Mexico, United States, 88011
        • Research Site
    • New York
      • New York, New York, United States, 10016
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Research Site
      • Raleigh, North Carolina, United States, 27617
        • Research Site
    • Ohio
      • Columbus, Ohio, United States, 43203
        • Research Site
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Research Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Research Site
    • Texas
      • Houston, Texas, United States, 77034
        • Research Site
      • Houston, Texas, United States, 77004
        • Research Site
    • Washington
      • Spokane, Washington, United States, 99204
        • 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

18 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must be willing to use 2 methods of effective contraception
  • Must have venous access
  • Must be willing to forego participation in other clinical trials for SLE.

Exclusion Criteria:

  • Any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product
  • Major surgery within 8 weeks before signing informed consent form (ICF)
  • Elective major surgery planned during the study period
  • Concomitant Medications within the last 12 weeks: Azathioprine > 200 mg/day, Mycophenolate mofetil/mycophenolic acid > 2.0 g/day, oral, subcutaneous, or intramuscular methotrexate > 25 mg/week
  • A live or attenuated vaccine within 4 weeks of signing the ICF
  • Bacillus of Calmette and Guérin (BCG) vaccine within 1 year of ICF

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: N/A
  • Interventional Model: Single Group 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: Anifrolumab
Participants will receive IV infusion of anifrolumab 1000 milligrams (mg) every 4 weeks (Q4W) from Day 1 (Week 0) until 12-Feb-2015 (approval of protocol amendment 4); and thereafter will receive 300 mg Q4W for up to 3 years or until the sponsor discontinued development of anifrolumab, whichever came first.
Biological: Anifrolumab
Intravenous infusion of anifrolumab will be administered as 1000 mg Q4W from Day 1 (Week 0) until 12-Feb-2015 (approval of protocol amendment 4); and thereafter 300 mg Q4W up to 3 years or until the sponsor discontinued development of anifrolumab, whichever came first.
Other Names:
  • MEDI-546

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
Measure Description
Time Frame
Number of Particpants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Time Frame: From first dose of study drug (Day 1) through 168 weeks
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
From first dose of study drug (Day 1) through 168 weeks
Number of Participants With Adverse Events Resulting in Discontinuation (DAEs) of Anifrolumab
Time Frame: From first dose of study drug (Day 1) through 168 weeks
Number of participants with DAEs are reported.
From first dose of study drug (Day 1) through 168 weeks
Number of Participants With Adverse Events of Special Interest (AESIs)
Time Frame: From first dose of study drug (Day 1) through 168 weeks
An AESI is scientific and medical concern specific to understanding of the study drug. An AESI may be serious or non-serious. Number of participants with AESIs are reported.
From first dose of study drug (Day 1) through 168 weeks

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
Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to Anifrolumab
Time Frame: Baseline (Pre-dose on Day 1) up to Week 168
The number of participants with positive serum antibodies to anifrolumab at anytime (including baseline) are reported.
Baseline (Pre-dose on Day 1) up to Week 168
Anti-Drug Antibodies (ADA) Titer to Anifrolumab
Time Frame: Baseline (Pre-dose on Day 1) up to Week 168
Median ADA titer in participants with ADA-positive assessments and reportable ADA titer results are reported.
Baseline (Pre-dose on Day 1) up to Week 168
Number of ADA-positive Participants With Decreased Serum Concentration of Anifrolumab
Time Frame: Baseline (Pre-dose on Day 1) up to Week 168
Number of participants with decreased serum concentration of anifrolumab due to ADA-positive results are reported.
Baseline (Pre-dose on Day 1) up to Week 168
Number of ADA-positive Participants With Decreased Pharmacodynamics Response of Anifrolumab
Time Frame: Baseline (Pre-dose on Day 1) up to Week 168
Number of participants with decreased pharmacodynamic response of anifrolumab due to ADA-positive results are reported.
Baseline (Pre-dose on Day 1) up to Week 168
Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Global Score for ADA Positive Participants
Time Frame: Baseline (Pre-dose on Day 1); and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 160, and 168
The SLEDAI-2K is an activity index that measures disease activity and records feature of active lupus as present or not present. SLEDAI-2K uses a weighted checklist to assign a numerical score based on the presence or absence of 24 symptoms. Each symptom present is assigned between 1 and 8 points based on its usual clinical importance, yielding a total score that ranges from 0 points (no symptoms) to 105 points (presence of all defined symptoms).
Baseline (Pre-dose on Day 1); and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 160, and 168
Number of ADA-positive Participants With TEAEs and TESAEs
Time Frame: Baseline (Pre-dose on Day 1) up to Week 168
The number of ADA-positive participants with TEAEs and TESAEs are reported.
Baseline (Pre-dose on Day 1) up to Week 168

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

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 (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.
March 28, 2013

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.
July 18, 2018

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 18, 2018

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 17, 2012

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 17, 2012

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 20, 2012

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.
July 31, 2019

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.
July 11, 2019

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.
July 1, 2019

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.
  • CD-IA-MEDI-546-1145
  • 2012-004619-30 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

AstraZeneca's policy is to share data with researchers if the request is in scope of our policy. Additional information can be found on astrazenecaclinicaltrials.com.

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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