Systemic Lupus ErythematosusPhase 2NCT01438489
A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus Erythematosus
A Phase 2 study testing Anifrolumab 300 mg and Anifrolumab 1000 mg in people with Systemic Lupus Erythematosus, run by MedImmune LLC at 79 sites in 14 countries.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of MEDI-546 compared to placebo in subjects with chronic, moderately-to-severely active systemic lupus erythematosus (SLE) with an inadequate response to standard of care treatment for SLE. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Anifrolumab 300 mg and Anifrolumab 1000 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 626 participants
- Where
- 79 sitesin 14 countries
- Study dates
- Jan 2012to Apr 2015
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fulfills at least 4 of the 11 American College of Rheumatology (ACR) criteria for systemic lupus erythematosus (SLE) including a positive antinuclear antibody (ANA) greater than or equal to 1:80 or elevated anti-double-stranded DNA or anti-Smith antibody at screening
- Pediatric or adult SLE with chronic disease activity for greater than or equal to 24 weeks
- Weight greater than or equal to 40 kg
- Currently receiving stable dose of oral prednisone (or equivalent) less than or equal to 40 mg/day and/or antimalarials/immunosuppressives
- Active moderate to severe SLE disease based on SLE disease activity score (SLEDAI) and British Isles Lupus Assessment Group Index (BILAG) and Physicians Global Assessment
- No evidence of cervical malignancy on Pap smear within 2 years of randomization
- Female participants must be willing to avoid pregnancy
- Negative tuberculosis (TB) test or newly positive TB test due to latent TB for which treatment must be initiated at or before randomization.
Who cannot join
- Active severe SLE-driven renal disease or unstable renal disease prior to screening
- Active severe or unstable neuropsychiatric SLE
- Clinically significant active infection including ongoing and chronic infections
- History of human immunodeficiency virus (HIV)
- Confirmed Positive tests for hepatitis B or positive test for hepatitis C
- History of severe herpes infection such as herpes encephalitis, ophthalmic herpes, disseminated herpes
- Live or attenuated vaccine within 4 weeks prior to screening
- Participants with significant hematologic abnormalities.
Trial locations and contacts
79 sites in 14 countries.
79 sites in 14 countries
United States30 sites
Research Site
Atlanta, Georgia
Research Site
Birmingham, Alabama
Research Site
Charlotte, North Carolina
Research Site
Chicago, Illinois
Research Site
Columbus, Ohio
Research Site
Decatur, Georgia
Research Site
Edmond, Oklahoma
Research Site
Houston, Texas
Research Site
Idaho Falls, Idaho
Research Site
Indianapolis, Indiana
Research Site
La Jolla, California
Research Site
La Palma, California
Research Site
Las Cruces, New Mexico
Research Site
Long Beach, California
Research Site
Los Angeles, California
Research Site
Memphis, Tennessee
Research Site
Miami, Florida
Research Site
New York, New York
Research Site
Ocala, Florida
Research Site
Orlando, Florida
Research Site
Palm Desert, California
Research Site
Palm Harbor, Florida
Research Site
Raleigh, North Carolina
Research Site
San Leandro, California
Research Site
Seattle, Washington
Research Site
Spokane, Washington
Research Site
Stockbridge, Georgia
Research Site
Tampa, Florida
Research Site
Tulsa, Oklahoma
Research Site
Upland, California
Ukraine7 sites
Research Site
Donetsk
Research Site
Kyiv
Research Site
Luhansk
Research Site
Lviv
Research Site
Ternopil
Research Site
Vinnitsya
Research Site
Vinnytsia
India6 sites
Research Site
Dantoli-Nagpur
Research Site
Hyderabad
Research Site
Mumbai
Research Site
New Delhi
Research Site
Pune
Research Site
Secunderabad
Colombia5 sites
Research Site
Barranquilla
Research Site
Bogotá
Research Site
Bucaramanga
Research Site
Chía
Research Site
Medellín
Poland5 sites
Research Site
Bialystok
Research Site
Bydgoszcz
Research Site
Krakow
Research Site
Nadarzyn
Research Site
Poznan
Mexico4 sites
Research Site
Guadalajara
Research Site
León
Research Site
México
Research Site
Toluca
South Korea4 sites
Research Site
Gwangjin-gu
Research Site
Gwangju
Research Site
Seodaemun-gu
Research Site
Suwon
Taiwan4 sites
Research Site
Chiayi City
Research Site
Kaohsiung City
Research Site
Taichung
Research Site
Taipei
Czechia3 sites
Research Site
Brno
Research Site
Prague
Research Site
Uherské Hradiště
Romania3 sites
Research Site
Brasov
Research Site
Iași
Research Site
Târgu Mureş
About this study
Official title: A Phase 2, Randomized Study to Evaluate the Efficacy and Safety of MEDI-546 in Subjects With Systemic Lupus Erythematosus
The purpose of this study is to evaluate the efficacy and safety of MEDI-546 compared to placebo in subjects with chronic, moderately-to-severely active systemic lupus erythematosus (SLE) with an inadequate response to standard of care treatment for SLE.
Read the detailed description
This is a Phase 2, multinational, multicenter, randomized, double-blind, placebo controlled, parallel-group study to evaluate the efficacy and safety of 2 intravenous (IV) treatment regimens in adult participants with chronic, moderately-to-severely active SLE with an inadequate response to SOC SLE. The investigational product (anifrolumab or placebo) will be administered as a fixed dose every 4 weeks (28 days) for a total of 13 doses.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Anifrolumab 300 mg, Anifrolumab 1000 mg, Placebo
- Keywords
- MEDI-546, Anifrolumab, 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.
Anifrolumab 300 mgBiological
Also called MEDI-546
Participants will receive 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
Anifrolumab 1000 mgBiological
Also called MEDI-546
Participants will receive 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
PlaceboOther
Participants will receive placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Anifrolumab (MEDI-546) 300 mg | Experimental | Participants will receive 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks. Receives: Biological: Anifrolumab 300 mg |
| Anifrolumab (MEDI-546) 1000 mg | Experimental | Participants will receive 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks. Receives: Biological: Anifrolumab 1000 mg |
| Matching Placebo | Placebo comparator | Participants will receive placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving an Systemic Lupus Erythematosus (SLE) Responder Index [SRI (4)] Response With Oral Corticosteroids (OCS) Tapering at Day 169
An SRI (4) responder defined as a participant who had 1) a reduction in baseline Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of greater than or equal to (>=) 4 points; 2) no worsening of disease from baseline as measured by the Physician Global Assessment (MDGA) (worsening was defined as an increase of >= 0.3 from baseline on a 0 to 3.0 visual analog scale); and 3) no new British Isles Lupus Assessment Group 2004 (BILAG-2004) Index 'A' organ system score and no more than one new or worsening BILAG-2004 Index 'B' organ system score. OCS tapering requires a sustained reduction of OCS from Day 85 through Day 169 [less than 10 milligram per day (mg/day) and less or equal to the dose received on Day 1]. SRI was analyzed by a logistic regression model.
Measured: Day 169
Percentage of Type I Interferon (IFN) Test High Participants Achieving an Systemic Lupus Erythematosus Responder Index (SRI) (4) Response With Oral Corticosteroids (OCS) Tapering at Day 169
Type I IFN signature in whole blood assessed by using a 4-gene diagnostic test. The blood samples collected were to be used to prospectively identify participants as IFN test-high or test-low. The results of this test were used to stratify participants. An SRI (4) Responder was defined as a participant who had 1) a reduction in baseline SLEDAI-2K disease activity score of >= 4 points; 2) no worsening of disease from baseline as measured by the Physician Global Assessment (MDGA) (worsening was defined as an increase of >= 0.3 from baseline on a 0 to 3.0 visual analog scale); and 3) no new British Isles Lupus Assessment Group 2004 (BILAG-2004) Index A organ system score and no more than one new or worsening BILAG-2004 Index B organ system score. OCS tapering requires a sustained reduction of OCS from Day 85 through Day 169 [less than 10 mg/day and less or equal to the dose received on Day 1]. SRI was analyzed by a logistic regression model.
Measured: Day 169
Secondary outcomes (12)
Percentage of Participants Achieving an Systemic Lupus Erythematosus (SLE) Responder Index [SRI (4)] Response With Oral Corticosteroids (OCS) Tapering at Day 365
An SRI (4) Responder was defined as a participant who had 1) a reduction in baseline SLEDAI-2K disease activity score of >= 4 points; 2) no worsening of disease from baseline as measured by the MDGA (worsening was defined as an increase of >= 0.3 from baseline on a 0 to 3.0 visual analog scale); and 3) no new British Isles Lupus Assessment Group 2004 (BILAG-2004) Index A organ system score and no more than one new or worsening BILAG-2004 Index B organ system score. OCS tapering requires a sustained reduction of OCS from Day 281 through Day 365 (less than 10 mg/day and less or equal to the dose received on Day 1). SRI was analyzed by a logistic regression model.
Measured: Day 365
Percentage of Participants on Oral Corticosteroids (OCS) >=10 mg/Day of Prednisone or Equivalent at Baseline Who Were Able to Taper to Less Than or Equal to (<=) 7.5 mg/Day at Day 365
Participants on OCS >=10 mg/day of prednisone or equivalent at baseline who were able to taper to <= 7.5 mg/day at Day 365 were evaluated.
Measured: Day 365
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs) and Treatment-Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) was any untoward medical occurrence in a study participant administered a pharmaceutical product and which does not necessarily have a causal relationship with treatment. A serious AE (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly (in offspring of participant). AEs may be treatment emergent (TE) [that is, occurring after initial receipt of investigational product] or non-TE. An AESI is one of scientific and medical concern specific to understanding biologics and requires close monitoring and rapid communication by investigator to sponsor.
Measured: Day 1 (Baseline) to Day 422 (End of Study)
Number of Participants With Clinically Significant Laboratory Abnormalities in Investigations Reported as Treatment-Emergent Adverse Events
Any medically significant change in laboratory evaluations were recorded as Treatment emergent adverse events.
Measured: Day 1 (Baseline) to Day 422 (End of Study)
Number of Participants With Vital Signs Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Vital sign parameters are temperature, blood pressure, respiratory rate, heart rate and weight. Vital signs abnormalities were reported as TEAEs.
Measured: Day 1 (Baseline) to Day 422 (End of Study)
Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Any medically significant changes from the screening ECG was recorded as TEAEs. An abnormal ECG findings such as QT prolonged were reported as treatment emergent adverse events.
Measured: Day 1 (Baseline) to Day 422 (End of Study)
Percentage of SLE Participants With Positive Anti-drug Antibody (ADA)
Anti-drug antibody responses to anifrolumab in serum were evaluated.
Measured: Days 1, 85, 141, 169, 253, 337 (Treatment Phase), 365, 396, and 422 (Follow-up Period)
Neutralization Ratio of 21-Gene Type I Interferon (IFN) Signature for Participants With Positive Baseline Pharmacodynamic (PD) Gene Signature
The PD positive and negative gene signature was determined by comparing the expression of type I IFN-inducible genes in a 21-gene panel in study participants relative to pooled normal blood collected from healthy participants.
Measured: Days 29, 85, 141, 169, 253, 337 (treatment phase), on Days 365, 396, and 422 (follow up period)
Maximum Observed Plasma Concentration (Cmax) of Anifrolumab at Day 1, 169 and 337
Maximum plasma concentration (Cmax) was defined as the peak plasma level of anifrolumab, derived from plasma concentration -time data.
Measured: Pre-infusion and 15 minutes post-infusion on Day 1, 169 and 337
Accumulation Ratio of Maximum Observed Plasma Concentration (Cmax,AR) of Anifrolumab
Accumulation ratio for maximum plasma concentration (Cmax,AR) of anifrolumab after multiple administration at Day 169 and 337 was calculated.
Measured: Pre-infusion and 15 minutes post-infusion on Day 169 and 337
Trough Concentration (Ctrough) of Anifrolumab at Day 29, 169 and 365
Trough concentration (Ctrough) of anifrolumab at Day 29, 169 and 365 were calculated.
Measured: Pre-infusion and 15 minutes post-infusion on Day 29, 169 and 365
Accumulation Ratio of Trough Concentration (Ctrough,AR) of Anifrolumab at Day 169 and 365
Accumulation ratio for trough concentration (Ctrough,AR) of anifrolumab after multiple administration at Day 169 and 365 was calculated.
Measured: Pre-infusion and 15 minutes post-infusion on Day 169 and 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2011 (estimated)
- Study startJan 2012
- Primary completionApr 2015
- Study completionApr 2015
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 (6)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 626 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Warren Greth, MD, Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01438489
- Sponsor's protocol ID
- CD-IA-MEDI-546-1013
- Status last verified
- Aug 2016
- First submitted
- 9 Sep 2011
- Last updated
- 7 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
PubMed 33687069Casey KA, Smith MA, Sinibaldi D, Seto NL, Playford MP, Wang X, Carlucci PM, Wang L, Illei G, Yu B, Wang S, Remaley AT, Mehta NN, Kaplan MJ, White WI. Modulation of Cardiometabolic Disease Markers by Type I Interferon Inhibition in Systemic Lupus Erythematosus. Arthritis Rheumatol. 2021 Mar;73(3):459-471. doi: 10.1002/art.41518. Epub 2021 Feb 15.
PubMed 32909675Brohawn PZ, Streicher K, Higgs BW, Morehouse C, Liu H, Illei G, Ranade K. Type I interferon gene signature test-low and -high patients with systemic lupus erythematosus have distinct gene expression signatures. Lupus. 2019 Nov;28(13):1524-1533. doi: 10.1177/0961203319885447. Epub 2019 Oct 29.
PubMed 31660791Casey KA, Guo X, Smith MA, Wang S, Sinibaldi D, Sanjuan MA, Wang L, Illei GG, White WI. Type I interferon receptor blockade with anifrolumab corrects innate and adaptive immune perturbations of SLE. Lupus Sci Med. 2018 Nov 22;5(1):e000286. doi: 10.1136/lupus-2018-000286. eCollection 2018.
PubMed 30538817Morand EF, Trasieva T, Berglind A, Illei GG, Tummala R. Lupus Low Disease Activity State (LLDAS) attainment discriminates responders in a systemic lupus erythematosus trial: post-hoc analysis of the Phase IIb MUSE trial of anifrolumab. Ann Rheum Dis. 2018 May;77(5):706-713. doi: 10.1136/annrheumdis-2017-212504. Epub 2018 Feb 2.
PubMed 29420200Furie R, Khamashta M, Merrill JT, Werth VP, Kalunian K, Brohawn P, Illei GG, Drappa J, Wang L, Yoo S; CD1013 Study Investigators. Anifrolumab, an Anti-Interferon-alpha Receptor Monoclonal Antibody, in Moderate-to-Severe Systemic Lupus Erythematosus. Arthritis Rheumatol. 2017 Feb;69(2):376-386. doi: 10.1002/art.39962.
PubMed 28130918
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized Study to Evaluate the Efficacy and Safety of MEDI-546 in Subjects With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT01438489
- Acronym / sponsor ID
- CD-IA-MEDI-546-1013
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- MEDI-546, Anifrolumab, Systemic Lupus Erythematosus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 626 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 22 Sep 2011 (estimated)
- Results
- Posted 15 Aug 2016
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 efficacy and safety of MEDI-546 compared to placebo in subjects with chronic, moderately-to-severely active systemic lupus erythematosus (SLE) with an inadequate response to standard of care treatment for SLE.
Detailed description
This is a Phase 2, multinational, multicenter, randomized, double-blind, placebo controlled, parallel-group study to evaluate the efficacy and safety of 2 intravenous (IV) treatment regimens in adult participants with chronic, moderately-to-severely active SLE with an inadequate response to SOC SLE. The investigational product (anifrolumab or placebo) will be administered as a fixed dose every 4 weeks (28 days) for a total of 13 doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anifrolumab (MEDI-546) 300 mg | Experimental | Biological: Anifrolumab 300 mgParticipants will receive 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks. |
| Anifrolumab (MEDI-546) 1000 mg | Experimental | Biological: Anifrolumab 1000 mgParticipants will receive 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks. |
| Matching Placebo | Placebo comparator | Other: PlaceboParticipants will receive placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Fulfills at least 4 of the 11 American College of Rheumatology (ACR) criteria for systemic lupus erythematosus (SLE) including a positive antinuclear antibody (ANA) greater than or equal to 1:80 or elevated anti-double-stranded DNA or anti-Smith antibody at screening
- Pediatric or adult SLE with chronic disease activity for greater than or equal to 24 weeks
- Weight greater than or equal to 40 kg
- Currently receiving stable dose of oral prednisone (or equivalent) less than or equal to 40 mg/day and/or antimalarials/immunosuppressives
- Active moderate to severe SLE disease based on SLE disease activity score (SLEDAI) and British Isles Lupus Assessment Group Index (BILAG) and Physicians Global Assessment
Key exclusion criteria (8 listed)
- Active severe SLE-driven renal disease or unstable renal disease prior to screening
- Active severe or unstable neuropsychiatric SLE
- Clinically significant active infection including ongoing and chronic infections
- History of human immunodeficiency virus (HIV)
- Confirmed Positive tests for hepatitis B or positive test for hepatitis C
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 |
|---|---|---|
| Anifrolumab 300 mgAlso: MEDI-546Participants will receive 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks. | Biological | Anifrolumab (MEDI-546) 300 mg |
| Anifrolumab 1000 mgAlso: MEDI-546Participants will receive 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks. | Biological | Anifrolumab (MEDI-546) 1000 mg |
| PlaceboParticipants will receive placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks. | Other | Matching Placebo |
Primary outcome
Percentage of Participants Achieving an Systemic Lupus Erythematosus (SLE) Responder Index [SRI (4)] Response With Oral Corticosteroids (OCS) Tapering at Day 169
Time frame: Day 169
An SRI (4) responder defined as a participant who had 1) a reduction in baseline Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of greater than or equal to (>=) 4 points; 2) no worsening of disease from baseline as measured by the Physician Global Assessment (MDGA) (worsening was defined as an increase of >= 0.3 from baseline on a 0 to 3.0 visual analog scale); and 3) no new British Isles Lupus Assessment Group 2004 (BILAG-2004) Index 'A' organ system score and no more than one new or worsening BILAG-2004 Index 'B' organ system score. OCS tapering requires a sustained reduction of OCS from Day 85 through Day 169 [less than 10 milligram per day (mg/day) and less or equal to the dose received on Day 1]. SRI was analyzed by a logistic regression model.
Percentage of Type I Interferon (IFN) Test High Participants Achieving an Systemic Lupus Erythematosus Responder Index (SRI) (4) Response With Oral Corticosteroids (OCS) Tapering at Day 169
Time frame: Day 169
Type I IFN signature in whole blood assessed by using a 4-gene diagnostic test. The blood samples collected were to be used to prospectively identify participants as IFN test-high or test-low. The results of this test were used to stratify participants. An SRI (4) Responder was defined as a participant who had 1) a reduction in baseline SLEDAI-2K disease activity score of >= 4 points; 2) no worsening of disease from baseline as measured by the Physician Global Assessment (MDGA) (worsening was defined as an increase of >= 0.3 from baseline on a 0 to 3.0 visual analog scale); and 3) no new British Isles Lupus Assessment Group 2004 (BILAG-2004) Index A organ system score and no more than one new or worsening BILAG-2004 Index B organ system score. OCS tapering requires a sustained reduction of OCS from Day 85 through Day 169 [less than 10 mg/day and less or equal to the dose received on Day 1]. SRI was analyzed by a logistic regression model.
12 secondary outcomes
Percentage of Participants Achieving an Systemic Lupus Erythematosus (SLE) Responder Index [SRI (4)] Response With Oral Corticosteroids (OCS) Tapering at Day 365
Time frame: Day 365
Percentage of Participants on Oral Corticosteroids (OCS) >=10 mg/Day of Prednisone or Equivalent at Baseline Who Were Able to Taper to Less Than or Equal to (<=) 7.5 mg/Day at Day 365
Time frame: Day 365
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Time frame: Day 1 (Baseline) to Day 422 (End of Study)
Number of Participants With Clinically Significant Laboratory Abnormalities in Investigations Reported as Treatment-Emergent Adverse Events
Time frame: Day 1 (Baseline) to Day 422 (End of Study)
Number of Participants With Vital Signs Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Time frame: Day 1 (Baseline) to Day 422 (End of Study)
Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Time frame: Day 1 (Baseline) to Day 422 (End of Study)
Percentage of SLE Participants With Positive Anti-drug Antibody (ADA)
Time frame: Days 1, 85, 141, 169, 253, 337 (Treatment Phase), 365, 396, and 422 (Follow-up Period)
Neutralization Ratio of 21-Gene Type I Interferon (IFN) Signature for Participants With Positive Baseline Pharmacodynamic (PD) Gene Signature
Time frame: Days 29, 85, 141, 169, 253, 337 (treatment phase), on Days 365, 396, and 422 (follow up period)
Maximum Observed Plasma Concentration (Cmax) of Anifrolumab at Day 1, 169 and 337
Time frame: Pre-infusion and 15 minutes post-infusion on Day 1, 169 and 337
Accumulation Ratio of Maximum Observed Plasma Concentration (Cmax,AR) of Anifrolumab
Time frame: Pre-infusion and 15 minutes post-infusion on Day 169 and 337
Trough Concentration (Ctrough) of Anifrolumab at Day 29, 169 and 365
Time frame: Pre-infusion and 15 minutes post-infusion on Day 29, 169 and 365
Accumulation Ratio of Trough Concentration (Ctrough,AR) of Anifrolumab at Day 169 and 365
Time frame: Pre-infusion and 15 minutes post-infusion on Day 169 and 365
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33687069Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
- Derived from this study: PubMed 32909675Casey KA, Smith MA, Sinibaldi D, Seto NL, Playford MP, Wang X, Carlucci PM, Wang L, Illei G, Yu B, Wang S, Remaley AT, Mehta NN, Kaplan MJ, White WI. Modulation of Cardiometabolic Disease Markers by Type I Interferon Inhibition in Systemic Lupus Erythematosus. Arthritis Rheumatol. 2021 Mar;73(3):459-471. doi: 10.1002/art.41518. Epub 2021 Feb 15.
- Derived from this study: PubMed 31660791Brohawn PZ, Streicher K, Higgs BW, Morehouse C, Liu H, Illei G, Ranade K. Type I interferon gene signature test-low and -high patients with systemic lupus erythematosus have distinct gene expression signatures. Lupus. 2019 Nov;28(13):1524-1533. doi: 10.1177/0961203319885447. Epub 2019 Oct 29.
- Derived from this study: PubMed 30538817Casey KA, Guo X, Smith MA, Wang S, Sinibaldi D, Sanjuan MA, Wang L, Illei GG, White WI. Type I interferon receptor blockade with anifrolumab corrects innate and adaptive immune perturbations of SLE. Lupus Sci Med. 2018 Nov 22;5(1):e000286. doi: 10.1136/lupus-2018-000286. eCollection 2018.
- Derived from this study: PubMed 29420200Morand EF, Trasieva T, Berglind A, Illei GG, Tummala R. Lupus Low Disease Activity State (LLDAS) attainment discriminates responders in a systemic lupus erythematosus trial: post-hoc analysis of the Phase IIb MUSE trial of anifrolumab. Ann Rheum Dis. 2018 May;77(5):706-713. doi: 10.1136/annrheumdis-2017-212504. Epub 2018 Feb 2.
- Derived from this study: PubMed 28130918Furie R, Khamashta M, Merrill JT, Werth VP, Kalunian K, Brohawn P, Illei GG, Drappa J, Wang L, Yoo S; CD1013 Study Investigators. Anifrolumab, an Anti-Interferon-alpha Receptor Monoclonal Antibody, in Moderate-to-Severe Systemic Lupus Erythematosus. Arthritis Rheumatol. 2017 Feb;69(2):376-386. doi: 10.1002/art.39962.
- Related InfoLink provided by the sponsor.
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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.
Warren Greth, MD study director
MedImmune LLC
79 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anifrolumab 300 mg and Anifrolumab 1000 mg in people with Systemic Lupus Erythematosus, run by MedImmune LLC at 79 sites in 14 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 8 inclusion and 8 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 7 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 79 sites in United States, Ukraine, India, Colombia, Poland and 9 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. Some participants in this study may receive a placebo. 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 15 Aug 2016). 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?
Percentage of Participants Achieving an Systemic Lupus Erythematosus (SLE) Responder Index [SRI (4)] Response With Oral Corticosteroids (OCS) Tapering at Day 169 (time frame: Day 169). The study lists 2 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 NCT01438489, which also lists 6 linked publications.
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 7 Oct 2016.