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OpenTrials
Completed

NCT Number: NCT01753193

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

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).

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Key information

Conditions

Lupus Erythematosus, Systemic Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Skin and Connective Tissue Diseases

Age range

18 year–68 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Rio de Janeiro, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anifrolumab

Biological

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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.

Sponsors and collaborators

Lead sponsor

MedImmune LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Dec 20, 2012
Registry last updated
Jul 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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