Back to resultsAn Open-label Study to Evaluate the Long-term Safety of MEDI-546, for the Treatment of SLE, in Adults
Primary Purpose
Lupus Erythematosus, Systemic
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Anifrolumab
Sponsored by
About this trial
This is an interventional treatment trial for Lupus Erythematosus, Systemic focused on measuring Systemic Lupus Erythematosus
Eligibility Criteria
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
Sites / Locations
- Research Site
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Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Anifrolumab
Arm Description
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.
Outcomes
Primary Outcome Measures
Number of Particpants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
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.
Number of Participants With Adverse Events Resulting in Discontinuation (DAEs) of Anifrolumab
Number of participants with DAEs are reported.
Number of Participants With Adverse Events of Special Interest (AESIs)
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 Outcome Measures
Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to Anifrolumab
The number of participants with positive serum antibodies to anifrolumab at anytime (including baseline) are reported.
Anti-Drug Antibodies (ADA) Titer to Anifrolumab
Median ADA titer in participants with ADA-positive assessments and reportable ADA titer results are reported.
Number of ADA-positive Participants With Decreased Serum Concentration of Anifrolumab
Number of participants with decreased serum concentration of anifrolumab due to ADA-positive results are reported.
Number of ADA-positive Participants With Decreased Pharmacodynamics Response of Anifrolumab
Number of participants with decreased pharmacodynamic response of anifrolumab due to ADA-positive results are reported.
Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Global Score for ADA Positive Participants
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).
Number of ADA-positive Participants With TEAEs and TESAEs
The number of ADA-positive participants with TEAEs and TESAEs are reported.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01753193
Brief Title
An Open-label Study to Evaluate the Long-term Safety of MEDI-546, for the Treatment of SLE, in Adults
Official Title
A Phase 2, Open-label Extension Study to Evaluate Long-term Safety of MEDI-546 in Adults With Systemic Lupus Erythematosus
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
March 28, 2013 (Actual)
Primary Completion Date
July 18, 2018 (Actual)
Study Completion Date
July 18, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedImmune LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Erythematosus, Systemic
Keywords
Systemic Lupus Erythematosus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
This is an Open Label Extension study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
218 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anifrolumab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Anifrolumab
Other Intervention Name(s)
MEDI-546
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Particpants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Description
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.
Time Frame
From first dose of study drug (Day 1) through 168 weeks
Title
Number of Participants With Adverse Events Resulting in Discontinuation (DAEs) of Anifrolumab
Description
Number of participants with DAEs are reported.
Time Frame
From first dose of study drug (Day 1) through 168 weeks
Title
Number of Participants With Adverse Events of Special Interest (AESIs)
Description
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.
Time Frame
From first dose of study drug (Day 1) through 168 weeks
Secondary Outcome Measure Information:
Title
Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to Anifrolumab
Description
The number of participants with positive serum antibodies to anifrolumab at anytime (including baseline) are reported.
Time Frame
Baseline (Pre-dose on Day 1) up to Week 168
Title
Anti-Drug Antibodies (ADA) Titer to Anifrolumab
Description
Median ADA titer in participants with ADA-positive assessments and reportable ADA titer results are reported.
Time Frame
Baseline (Pre-dose on Day 1) up to Week 168
Title
Number of ADA-positive Participants With Decreased Serum Concentration of Anifrolumab
Description
Number of participants with decreased serum concentration of anifrolumab due to ADA-positive results are reported.
Time Frame
Baseline (Pre-dose on Day 1) up to Week 168
Title
Number of ADA-positive Participants With Decreased Pharmacodynamics Response of Anifrolumab
Description
Number of participants with decreased pharmacodynamic response of anifrolumab due to ADA-positive results are reported.
Time Frame
Baseline (Pre-dose on Day 1) up to Week 168
Title
Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Global Score for ADA Positive Participants
Description
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).
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
Title
Number of ADA-positive Participants With TEAEs and TESAEs
Description
The number of ADA-positive participants with TEAEs and TESAEs are reported.
Time Frame
Baseline (Pre-dose on Day 1) up to Week 168
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
68 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Research Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Research Site
City
La Palma
State/Province
California
ZIP/Postal Code
90623
Country
United States
Facility Name
Research Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1670
Country
United States
Facility Name
Research Site
City
Palm Desert
State/Province
California
ZIP/Postal Code
92260
Country
United States
Facility Name
Research Site
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Research Site
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Research Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Research Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Research Site
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Research Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Research Site
City
Las Cruces
State/Province
New Mexico
ZIP/Postal Code
88011
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Research Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Research Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27617
Country
United States
Facility Name
Research Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43203
Country
United States
Facility Name
Research Site
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Research Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77034
Country
United States
Facility Name
Research Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Research Site
City
Rio de Janeiro
ZIP/Postal Code
22040-042
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
04032-060
Country
Brazil
Facility Name
Research Site
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Research Site
City
Barranquilla
Country
Colombia
Facility Name
Research Site
City
Bogota
Country
Colombia
Facility Name
Research Site
City
Bucaramanga
Country
Colombia
Facility Name
Research Site
City
Chia
Country
Colombia
Facility Name
Research Site
City
Medellin
Country
Colombia
Facility Name
Research Site
City
Brno
Country
Czechia
Facility Name
Research Site
City
Praha 2
Country
Czechia
Facility Name
Research Site
City
Debrecen
Country
Hungary
Facility Name
Research Site
City
Gwangju
Country
Korea, Republic of
Facility Name
Research Site
City
Seodaemun-gu
Country
Korea, Republic of
Facility Name
Research Site
City
Suwon-si
ZIP/Postal Code
16499
Country
Korea, Republic of
Facility Name
Research Site
City
Guadalajara
Country
Mexico
Facility Name
Research Site
City
Leon
Country
Mexico
Facility Name
Research Site
City
Mexico
Country
Mexico
Facility Name
Research Site
City
Toluca
Country
Mexico
Facility Name
Research Site
City
Arequipa
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
15033
Country
Peru
Facility Name
Research Site
City
Lima
Country
Peru
Facility Name
Research Site
City
Bialystok
ZIP/Postal Code
15-297
Country
Poland
Facility Name
Research Site
City
Krakow
ZIP/Postal Code
31-011
Country
Poland
Facility Name
Research Site
City
Nadarzyn
ZIP/Postal Code
05-830
Country
Poland
Facility Name
Research Site
City
Poznan
ZIP/Postal Code
61-397
Country
Poland
Facility Name
Research Site
City
Iasi
ZIP/Postal Code
700661
Country
Romania
Facility Name
Research Site
City
Chiayi
ZIP/Postal Code
622
Country
Taiwan
Facility Name
Research Site
City
Zhongzheng District
Country
Taiwan
Facility Name
Research Site
City
Donetsk
Country
Ukraine
Facility Name
Research Site
City
Kyiv
Country
Ukraine
Facility Name
Research Site
City
Ternopil
Country
Ukraine
Facility Name
Research Site
City
Vinnitsya
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
Research Site
City
Vinnytsia
ZIP/Postal Code
21018
Country
Ukraine
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
33225631
Citation
Chatham WW, Furie R, Saxena A, Brohawn P, Schwetje E, Abreu G, Tummala R. Long-Term Safety and Efficacy of Anifrolumab in Adults With Systemic Lupus Erythematosus: Results of a Phase II Open-Label Extension Study. Arthritis Rheumatol. 2021 May;73(5):816-825. doi: 10.1002/art.41598. Epub 2021 Mar 24. Erratum In: Arthritis Rheumatol. 2021 Aug;73(8):1570.
Results Reference
derived
Learn more about this trial
An Open-label Study to Evaluate the Long-term Safety of MEDI-546, for the Treatment of SLE, in Adults
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