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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02446912




Registration number
NCT02446912
Ethics application status
Date submitted
14/05/2015
Date registered
18/05/2015
Date last updated
5/12/2019

Titles & IDs
Public title
Efficacy and Safety of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus
Scientific title
A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus
Secondary ID [1] 0 0
D3461C00005
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Active Systemic Lupus Erythematosus 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Anifrolumab
Treatment: Drugs - Placebo

Experimental: Anifrolumab - higher dose - Anifrolumab

Placebo Comparator: Placebo - Placebo

Experimental: Anifrolumab - lower dose - Anifrolumab


Other interventions: Anifrolumab
Anifrolumab IV administration every 4 weeks from Week 0 to Week 48 for a total of 13 doses

Treatment: Drugs: Placebo
Placebo IV administration every 4 weeks from Week 0 to Week 48

Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Who Achieved a Systemic Lupus Erythematosus (SLE) Responder Index =4 (SRI[4]) at Week 52 (Original Analysis With Restricted Medication Rules) - SRI(4) was defined as meeting all of the following criteria:
Reduction from baseline of =4 points in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) No new organ systems affected, defined by 1 or more British Isles Lupus Assessment Group (BILAG-2004) A or 2 or more BILAG-2004 B items No worsening from baseline in participants lupus disease activity. Worsening was defined as an increase of =0.30 points on a 3-point Physician's Global Assessment (PGA) visual analogue scale (VAS) No discontinuation of investigational product and no use of restricted medications beyond the pre-specified analysis threshold.
Timepoint [1] 0 0
Week 52
Secondary outcome [1] 0 0
Number of Participants Who Achieved a Systemic Lupus Erythematosus (SLE) Responder Index of =4 at Week 52 in the Interferon (IFN) Test-High Sub-Group (Original Analysis With Restricted Medication Rules) - SRI(4) was defined as meeting all of the following criteria:
Reduction from baseline of =4 points in the SLEDAI-2K No new organ systems affected, defined by 1 or more BILAG-2004 A or 2 or more BILAG-2004 B No worsening from baseline in participants lupus disease activity. Worsening was defined as an increase of =0.30 points on a 3-point PGA VAS No discontinuation of investigational product and no use of restricted medications beyond the pre-specified analysis threshold.
Timepoint [1] 0 0
Week 52
Secondary outcome [2] 0 0
Number of Participants Who Achieved and Maintained an Oral Corticosteroid (OCS) Dose of =7.5 mg/Day in the Sub-group of Participants With Baseline OCS =10 mg/Day (Original Analysis With Restricted Medication Rules) - Maintained OCS reduction was defined by meeting all the following criteria:
Achieve an OCS dose of =7.5 mg/day prednisone or equivalent by Week 40 Maintain an OCS dose =7.5 mg/day prednisone or equivalent from Week 40 to Week 52 No discontinuation of investigational product and no use of restricted medications beyond the pre-specified analysis threshold.
Timepoint [2] 0 0
Week 52
Secondary outcome [3] 0 0
Number of Participants With a =50% Reduction in CLASI Activity Score at Week 12 in the Sub-group of Participants With Baseline CLASI Activity Score =10 (Original Analysis With Restricted Medication Rules) - 50% reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score compared to baseline was defined by meeting all of the following criteria:
Achieve =50% reduction of CLASI activity score at Week 12 compared to baseline No discontinuation of investigational product and no use of restricted medications beyond the pre-specified analysis threshold before assessment.
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Number of Participants Who Achieved a Systemic Lupus Erythematosus (SLE) Responder Index of =4 (SRI[4]) at Week 24 (Original Analysis With Restricted Medication Rules) - SRI(4) was defined as meeting all of the following criteria:
Reduction from baseline of =4 points in the SLEDAI-2K No new organ systems affected as defined by 1 or more BILAG-2004 A or 2 or more BILAG-2004 B items No worsening from baseline in participants lupus disease activity. Worsening was defined as an increase of =0.30 points on a 3-point PGA VAS No discontinuation of investigational product and no use of restricted medications beyond the pre-specified threshold.
Timepoint [4] 0 0
Week 24
Secondary outcome [5] 0 0
Annualized Flare Rate - A flare was defined as either 1 or more new British Isle Lupus Assessment Group (BILAG-2004) A or 2 or more new BILAG-2004 B items compared to the previous visit. The occurrence of a new flare was checked for each available visit versus the previous available visit up to Week 52. If no new flares occurred, the number of flares was set to 0. Otherwise all flares were counted leading to the maximum number of flares of 13. The annualized flare rate was calculated as the number of flares divided by the flare exposure time in days multiplied with 365.25 (1 year). The flare exposure time is the time up to Week 52 (date of BILAG-2004 assessment at Week 52) or up to the date of last available BILAG-2004 assessment.
Timepoint [5] 0 0
Baseline to Week 52
Secondary outcome [6] 0 0
Number of Participants Who Met the Criteria for British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) Response (Original Analysis With Restricted Medication Rules) - A BICLA responder was achieved if all of the following criteria was met:
All criteria related to SRI(4) (please see primary endpoint) plus:
Reduction of all baseline BILAG-2004 A to B/C/D and baseline BILAG-2004 B to C/D, and no BILAG-2004 worsening in other organ systems, as defined by 1 or more BILAG-2004 A or 1 or more new BILAG-2004 B item No discontinuation of investigational product and no use of restricted medications beyond the revised post-hoc analysis threshold before assessment.
Timepoint [6] 0 0
Week 52
Secondary outcome [7] 0 0
Number of Participants Reporting One or More Adverse Events (AE) - An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. AEs were collected throughout the duration of the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose [Week 48]), or until Week 52 for participants who enrolled onto the long term extension (LTE). The reported value is inclusive of serious and non-serious AEs.
Timepoint [7] 0 0
Baseline to End of Trial (Maximum of 60 weeks)
Secondary outcome [8] 0 0
Number of Participants Reporting One or More Adverse Events of Special Interest (AESI) - An AESI is an AE of scientific and medical concern specific to understanding biologics and requires close monitoring and rapid communication by the Investigator to the Sponsor/Sponsor's delegate. An AESI may be serious or nonserious. The events of interest are serious infections, including non opportunistic serious infections, opportunistic infections, anaphylaxis, malignancy, herpes zoster, TB (including latent TB), influenza, vasculitis (non-SLE), and MACE (including stroke, MI, or cardiovascular death).
AEs were collected throughout the duration of the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose [Week 48]), or until Week 52 for participants who enrolled onto the long term extension (LTE).
Timepoint [8] 0 0
Baseline to End of Trial (Maximum of 60 weeks)
Secondary outcome [9] 0 0
Number of Participants With Markedly Abnormal Vital Signs - Vital signs included oral temperature, blood pressure (BP), pulse rate, and respiratory rate.
Vital signs were collected throughout the duration of the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose [Week 48]), or until Week 52 for participants who enrolled onto the long term extension (LTE).
Timepoint [9] 0 0
Baseline to End of Trial (Maximum of 60 weeks)
Secondary outcome [10] 0 0
Number of Participants With Markedly Abnormal Physical Examinations - Physical examinations included height and weight. Participants were weighed at each study visit and any medically significant changes were reported.
Physical examination values were collected throughout the duration of the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose [Week 48]), or until Week 52 for participants who enrolled onto the long term extension (LTE).
Timepoint [10] 0 0
Baseline to End of Trial (Maximum of 60 weeks)
Secondary outcome [11] 0 0
Number of Participants With Markedly Abnormal Electrocardiogram (ECG) Scores - ECGs documented the date, time, heart rate, QRS duration, PR interval, RR interval, QT, and corrected QT interval, which were calculated using the Fridericia formula. The investigator judged the overall interpretation as normal or abnormal, and if abnormal it was decided as to whether or not the abnormality was clinically significant or not clinically significant.
Timepoint [11] 0 0
Baseline to Week 52
Secondary outcome [12] 0 0
Number of Participants With Mild To Moderate Lupus Flare Evaluated by Modified Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-SLEDAI Flare Index - The modified SELENA flare index was completed by the Investigator or delegated/qualified physician. Assessment of flares were scored in comparison to the participant's previous visit and should only include findings which, in the opinion of the Investigator, are due to systemic lupus erythematosus (SLE) disease activity within that timeframe. Flare was defined as any 1 criterion present in either the Mild/Moderate Flare or Severe Flare categories.
Number of flares were collected throughout the duration of the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose [Week 48]), or until Week 52 for participants who enrolled onto the long term extension (LTE).
Timepoint [12] 0 0
Baseline to End of Trial (Maximum of 60 weeks)
Secondary outcome [13] 0 0
Number of Participants With Markedly Abnormal Laboratory Tests - Laboratory tests were collected at central clinical laboratories and included hematology, serum chemistry and urinalysis tests. Laboratory values were collected throughout the duration of the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose [Week 48]), or until Week 52 for participants who enrolled onto the long term extension (LTE).
Timepoint [13] 0 0
Baseline to End of Trial (Maximum of 60 weeks)
Secondary outcome [14] 0 0
Number of Participants With Suicidal Ideation or Behaviour Assessed Via the Columbia Suicide Severity Rating Scale (C-SSRS) - The C-SSRS is an assessment tool that evaluates suicidal ideation and behavior. Number of participants with suicidal ideation or behavior was defined as the number of participants who answered "yes" at any time during the treatment period (Baseline to Week 52) to one of the 10 categories:
Category 1: Wish to be dead Category 2: Non-specific active suicidal thoughts Category 3: Active suicidal ideation with any methods (not plan) without intent to act Category 4: Active suicidal ideation with some intent to act, without specific plan Category 5: Active suicidal ideation with specific plan and intent Category 6: Preparatory acts or behavior Category 7: Aborted attempt Category 8: Interrupted attempt Category 9: Actual attempt (non-fatal) Category 10: Completed suicide
Timepoint [14] 0 0
Baseline to Week 52
Secondary outcome [15] 0 0
Change From Baseline in Personal Health Questionnaire Depression Scale-8 (PHQ-8) Score - PHQ-8 is a 8-item self-report scale, all items are rated on a score of 0-3, for a total range of 0-24. PHQ-8 assesses symptoms of depression over the previous 2 weeks. Higher scores indicate more depressive symptoms. A negative change from baseline score indicates improvement in symptoms.
Timepoint [15] 0 0
Baseline to Week 52

Eligibility
Key inclusion criteria
1. Aged 18 through 70 years at the time of screening

2. Diagnosis of paediatric or adult SLE with a diagnosis of SLE according to the ACR 1982
revised criteria =24 weeks prior to signing the Informed Consent form (ICF)

3. Currently receiving at least 1 of the following:

1. Where prednisone is the single standard of care medication (ie, the subject is
not concurrently receiving any medication listed in inclusion criterion 3(c)), a
dose of oral prednisone =7.5 mg/day but =40 mg/day (or prednisone equivalent) for
a minimum of 8 weeks prior to Day 1. In addition, the dose of oral prednisone or
prednisone equivalent the subject is taking must be stable for a minimum of 2
weeks prior to randomisation.

2. Where prednisone is not the single standard of care medication (ie, the subject
is concurrently receiving at least one medication listed in inclusion criterion
3(c)), a dose of oral prednisone (=40 mg/day) (or prednisone equivalent) for a
minimum of 2 weeks prior to signing of the ICF. In addition, the dose of oral
prednisone or prednisone equivalent the subject is taking must be stable for a
minimum of 2 weeks prior to randomisation.

3. Any of the following medications administered for a minimum of 12 weeks prior to
signing the informed consent, and at a stable dose for a minimum of 8 weeks prior
to signing the informed consent through Day 1:

(i) Azathioprine =200 mg/day (ii) Antimalarial (eg, chloroquine, hydroxychloroquine,
quinacrine) (iii) Mycophenolate mofetil =2 g/day or mycophenolic acid =1.44 g/day (iv)
Oral, subcutaneous (SC), or intramuscular methotrexate =25 mg/week (v) Mizoribine =150
mg/day

4. Fulfils at least 4 of the 11 ACR modified 1982 classification criteria for SLE, at
least 1 of which must be:

1. Positive antinuclear antibody (ANA) test at screening by immunofluorescent assay
(IFA) at the central laboratory with titre =1:80; OR

2. Anti-dsDNA antibodies at screening elevated to above normal (including
indeterminante), as per the central laboratory; OR

3. Anti-Smith (anti-Sm) antibody at screening elevated to above normal as per the
central laboratory.

5. At Screening, Disease Activity Adjudication Group confirmation of:

SLEDAI-2K Criteria: SLEDAI-2K score =6 points and "Clinical" SLEDAI-2K score =4
points. The "Clinical" SLEDAI-2K is the SLEDAI-2K assessment score without the
inclusion of points attributable to any urine or laboratory results including
immunologic measures.

6. Must not have active or latent TB on either chest radiograph or by quantiferon gold
test

7. Day 1 "Clinical" SLEDAI-2K score =4 points

8. OCS dose stable for at least 2 weeks prior to randomisation

9. Stable SLE SOC treatment at the time of randomisation

10. Women of child-bearing potential must have a negative serum ß-hCG test and negative
urine pregnancy test at randomisation (Day 1) prior to administration of
investigational product
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Receipt of any investigational product (small molecule or biologic agent) within 4
weeks or 5 half-lives prior to signing of the ICF, whichever is greater

2. Receipt of any of the following:

(a) Intra-articular, intramuscular or IV glucocorticosteroids within 6 weeks prior to
Day 1

3. History of, or current diagnosis of, a clinically significant non SLE-related
vasculitis syndrome.

4. Active severe or unstable neuropsychiatric SLE

5. Active severe SLE-driven renal disease

6. Diagnosis (within 1 year of signing the ICF) of mixed connective tissue disease or any
history of overlap syndromes of SLE or SSc.

7. History of, or current, inflammatory joint or skin disease other than SLE

8. History of any non-SLE disease that has required treatment with oral or parenteral
corticosteroids for more than 2 weeks within the last 24 weeks prior to signing the
ICF

9. Known history of a primary immunodeficiency, splenectomy, or any underlying condition
that predisposes the subject to infection, or a positive result for human
immunodeficiency virus (HIV) infection confirmed by central laboratory at screening.
Subjects refusing HIV testing during the screening period will not be eligible for
study participation

10. Confirmed positive test for hepatitis B or hepatitis C

11. Any severe herpes infection at any time prior to Week 0 (Day 1)

12. Opportunistic infection requiring hospitalisation or intravenous antimicrobial
treatment within 3 years prior to randomization

13. History of cancer, apart from:

1. Squamous or basal cell carcinoma of the skin that has been successfully treated

2. Cervical cancer in situ that has been successfully treated

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Fitzroy
Recruitment hospital [2] 0 0
Research Site - Kogarah
Recruitment hospital [3] 0 0
Research Site - St Leonards
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2065 - St Leonards
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
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California
Country [3] 0 0
United States of America
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Colorado
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Florida
Country [5] 0 0
United States of America
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Georgia
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Idaho
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Louisiana
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Maryland
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Michigan
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Minnesota
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New Hampshire
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New Jersey
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New York
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North Carolina
Country [15] 0 0
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Ohio
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Oklahoma
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Wisconsin
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Argentina
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Cordoba
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Argentina
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San Miguel de Tucuman
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Brazil
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Belo Horizonte
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Brazil
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Juiz de Fora
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Brazil
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Porto Alegre
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Brazil
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Salvador
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Chile
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Osorno
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Chile
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Santiago
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Chile
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Vina del Mar
Country [31] 0 0
Colombia
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Armenia
Country [32] 0 0
Colombia
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Barranquilla
Country [33] 0 0
Colombia
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Bogota
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Colombia
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Bucaramanga
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Colombia
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Medellin
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Germany
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Berlin
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Germany
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Dessau-RoBlau
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Germany
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Frankfurt am Main
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Germany
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Göttingen
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Kirchheim
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Germany
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Köln
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Szeged
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Hungary
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Zalaegerszeg
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Kfar Saba
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Israel
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Petach-Tikva
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Israel
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Tel Aviv
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Italy
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Milano
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Italy
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Padova
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Korea, Republic of
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Daejeon
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Korea, Republic of
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Gwangju
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Korea, Republic of
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Jeonju-si
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Korea, Republic of
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Seoul
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Korea, Republic of
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Suwon-si
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New Zealand
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Hamilton
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New Zealand
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Wellington
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Peru
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Arequipa
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Peru
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Lima
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Poland
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Bialystok
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Bydgoszcz
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Elblag
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Kraków
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Lublin
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Nadarzyn
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Poznan
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Sosnowiec
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Starachowice
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Szczecin
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Ustron
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Warszawa
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Romania
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Brasov
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Romania
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Bucharest
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Romania
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Bucuresti
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Romania
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Cluj Napoca
Country [78] 0 0
Romania
State/province [78] 0 0
Galati
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Romania
State/province [79] 0 0
Tg Mures
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Taiwan
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Kaohsiung Hsien
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Taiwan
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Taichung
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Taiwan
State/province [82] 0 0
Taipei
Country [83] 0 0
Ukraine
State/province [83] 0 0
Kiev
Country [84] 0 0
Ukraine
State/province [84] 0 0
Kyiv
Country [85] 0 0
Ukraine
State/province [85] 0 0
Lviv
Country [86] 0 0
Ukraine
State/province [86] 0 0
Ternopil
Country [87] 0 0
Ukraine
State/province [87] 0 0
Uzhgorod
Country [88] 0 0
Ukraine
State/province [88] 0 0
Vinnytsia
Country [89] 0 0
Ukraine
State/province [89] 0 0
Zaporizhzhia
Country [90] 0 0
United Kingdom
State/province [90] 0 0
Brighton
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United Kingdom
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Doncaster
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United Kingdom
State/province [92] 0 0
Leeds
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United Kingdom
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London
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United Kingdom
State/province [94] 0 0
Manchester
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United Kingdom
State/province [95] 0 0
Romford
Country [96] 0 0
United Kingdom
State/province [96] 0 0
Staffordshire

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
PRA Health Sciences
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment
regimen of two doses of anifrolumab versus placebo in adult subjects with moderately to
severely active, autoantibody-positive systemic lupus erythematosus (SLE).
Trial website
https://clinicaltrials.gov/show/NCT02446912
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Herbert Hutman, MD
Address 0 0
Medical Science Director
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications