Lupus Erythematosus, SystemicPhase 2NCT01753193
An Open-label Study to Evaluate the Long-term Safety of MEDI-546, for the Treatment of SLE, in Adults
A Phase 2 study testing Anifrolumab in people with Lupus Erythematosus, Systemic, run by MedImmune LLC at 57 sites in 13 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 68 years
- Conditions the study is for
- Lupus Erythematosus, Systemic
- What is being tested?
- Anifrolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 57 sitesin 13 countries
- Study dates
- 28 Mar 2013to 18 Jul 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
57 sites in 13 countries.
57 sites in 13 countries
United States23 sites
Research Site
Atlanta, Georgia, 30281
Research Site
Birmingham, Alabama, 35294
Research Site
Charlotte, North Carolina, 28204
Research Site
Chicago, Illinois, 60637
Research Site
Columbus, Ohio, 43203
Research Site
Houston, Texas, 77004
Research Site
Houston, Texas, 77034
Research Site
Indianapolis, Indiana, 46202
Research Site
La Palma, California, 90623
Research Site
Las Cruces, New Mexico, 88011
Research Site
Long Beach, California, 90806
Research Site
Los Angeles, California, 90095-1670
Research Site
Memphis, Tennessee, 38119
Research Site
New York, New York, 10016
Research Site
Ocala, Florida, 34474
Research Site
Orlando, Florida, 32806
Research Site
Palm Desert, California, 92260
Research Site
Raleigh, North Carolina, 27617
Research Site
Spokane, Washington, 99204
Research Site
Stockbridge, Georgia, 30281
Research Site
Tampa, Florida, 33614
Research Site
Tulsa, Oklahoma, 74104
Research Site
Upland, California, 91786
Colombia5 sites
Research Site
Barranquilla
Research Site
Bogotá
Research Site
Bucaramanga
Research Site
Chía
Research Site
Medellín
Ukraine5 sites
Research Site
Donetsk
Research Site
Kyiv
Research Site
Ternopil
Research Site
Vinnitsya, 21029
Research Site
Vinnytsia, 21018
Mexico4 sites
Research Site
Guadalajara
Research Site
León
Research Site
México
Research Site
Toluca
Poland4 sites
Research Site
Bialystok, 15-297
Research Site
Krakow, 31-011
Research Site
Nadarzyn, 05-830
Research Site
Poznan, 61-397
South Korea3 sites
Research Site
Gwangju
Research Site
Seodaemun-gu
Research Site
Suwon, 16499
Brazil2 sites
Research Site
Rio de Janeiro, 22040-042
Research Site
São Paulo, 04032-060
About this study
Official title: 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).
Read the 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.
- Conditions
- Lupus Erythematosus, Systemic
- Being tested
- Anifrolumab
- Keywords
- Systemic Lupus Erythematosus
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnifrolumabBiological
Also called MEDI-546
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.
| Study group | Role | What they receive |
|---|---|---|
| Anifrolumab | Experimental | 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. Receives: Biological: Anifrolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From first dose of study drug (Day 1) through 168 weeks
Number of Participants With Adverse Events Resulting in Discontinuation (DAEs) of Anifrolumab
Number of participants with DAEs are reported.
Measured: From first dose of study drug (Day 1) through 168 weeks
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.
Measured: From first dose of study drug (Day 1) through 168 weeks
Secondary outcomes (6)
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.
Measured: Baseline (Pre-dose on Day 1) up to Week 168
Anti-Drug Antibodies (ADA) Titer to Anifrolumab
Median ADA titer in participants with ADA-positive assessments and reportable ADA titer results are reported.
Measured: Baseline (Pre-dose on Day 1) up to Week 168
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.
Measured: Baseline (Pre-dose on Day 1) up to Week 168
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.
Measured: 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
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).
Measured: 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
The number of ADA-positive participants with TEAEs and TESAEs are reported.
Measured: Baseline (Pre-dose on Day 1) up to Week 168
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2012 (estimated)
- Study start28 Mar 2013
- Primary completion18 Jul 2018
- Study completion18 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lupus Erythematosus, SystemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an Open Label Extension study.
- Masking
- None (open label)
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01753193
- Sponsor's protocol ID
- CD-IA-MEDI-546-1145
- Other IDs
- 2012-004619-30
- Status last verified
- Jul 2019
- First submitted
- 17 Dec 2012
- Last updated
- 31 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 33225631
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-label Extension Study to Evaluate Long-term Safety of MEDI-546 in Adults With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT01753193
- Acronym / sponsor ID
- CD-IA-MEDI-546-1145
- Conditions
- Lupus Erythematosus, Systemic
- Keywords
- Systemic Lupus Erythematosus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- 28 Mar 2013 (actual)
- Primary completion
- 18 Jul 2018 (actual)
- Study completion
- 18 Jul 2018 (actual)
- First posted
- 20 Dec 2012 (estimated)
- Results
- Posted 31 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an Open Label Extension study.
| Arm | Type | Receives |
|---|---|---|
| Anifrolumab | Experimental | Biological: AnifrolumabParticipants 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. |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AnifrolumabAlso: MEDI-546Intravenous 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. | Biological | Anifrolumab |
Primary outcome
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.
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.
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.
6 secondary outcomes
Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to Anifrolumab
Time frame: 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
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 ADA-positive Participants With Decreased Pharmacodynamics Response of Anifrolumab
Time frame: 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
Number of ADA-positive Participants With TEAEs and TESAEs
Time frame: Baseline (Pre-dose on Day 1) up to Week 168
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33225631Chatham 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
57 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anifrolumab in people with Lupus Erythematosus, Systemic, run by MedImmune LLC at 57 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in United States, Colombia, Ukraine, Mexico, Poland and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01753193, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2019.