Safety and Efficacy of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Proliferative Lupus Nephritis
NCT ID: NCT02547922
Last Updated: 2021-11-24
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
147 participants
INTERVENTIONAL
2015-11-04
2021-01-18
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Anifrolumab - Lower Dose
Anifrolumab - Lower Dose
Anifrolumab
Administration every 4 week from Week 0 to Week 100 in addition to SOC which will continue until Week 112
Anifrolumab - Higher Dose
Anifrolumab - Higher Dose
Anifrolumab
Administration every 4 week from Week 0 to Week 100 in addition to SOC which will continue until Week 112
Placebo
Placebo IV Q4W plus SOC
Placebo
Administration every 4 week from Week 0 to Week 100 in addition to SOC which will continue until Week 112
Interventions
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Anifrolumab
Administration every 4 week from Week 0 to Week 100 in addition to SOC which will continue until Week 112
Placebo
Administration every 4 week from Week 0 to Week 100 in addition to SOC which will continue until Week 112
Eligibility Criteria
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Inclusion Criteria
2. Fulfils at least 4 of the 11 criteria of the revised 1982 ACR classification criteria for SLE, at least one of which must be:
1. Positive antinuclear antibody (ANA) test (1:40 or higher) or
2. Elevated anti-dsDNA antibodies at screening (reported as equivocal or positive results), as per the centrallaboratory; or
3. Anti-Smith antibody at screening elevated to above normal (ie, positive or equivocal results) as per the central laboratory
3. Class III (±Class V) or Class IV (±Class V) LN according to the World Health Organisation (WHO) or 2003 ISN/RPS classification based on a renal biopsy obtained within 12 weeks prior to signing the ICF or during the screening period:
4. Urine protein to creatinine ratio \>1 gm/gm (113.17 mg/mmol), obtained on a 24-hour urine collection at screening
5. Estimated glomerular filtration rate ≥35 mL/min/1.73 m2
6. Must not have active or latent TB on either chest radiograph or by Quantiferon gold test
7. Women of childbearing potential must have a negative serum beta-hCG test at screening and negative urine pregnancy test prior to the first dose of sponsor-provided MMF.
Exclusion Criteria
2. Pure Class V membranous LN on a renal biopsy obtained within 12 weeks prior to signing ICF or during the screening period
3. Known intolerance to ≤1.0 gm/day of MMF
4. History of dialysis within 12 months prior to signing the ICF or expected need for renal replacement therapy (dialysis or renal transplant) within a 6 month period after enrolment
5. Subjects, who at the time of signing the ICF, received any of the following immunosuppressive therapies after their qualifying biopsy
1. Oral corticosteroids \>0.5 mg/kg/day for more than 8 weeks or
2. Oral or IV pulse methylprednisolone \>3.0 gm (cumulative dose) or
3. IV cyclophosphamide \>2 pulses of high-dose (≥0.5 gm/m2) or \>4 doses of low dose (500 mg every 2 weeks) or
4. Average MMF \>2.5 gm/day (\>1800 mg/day of enteric-coated mycophenolate sodium) for more than 8 weeks or
5. Tacrolimus \>4 mg/day for more than 8 weeks
6. Major surgery within 8 weeks before signing the ICF or major surgery planned during the study period
7. History of any non-SLE disease that has required treatment with oral or parenteral corticosteroids for more than a total of 2 weeks within the last 24 weeks prior to signing the ICF
8. Confirmed positive test for hepatitis B or hepatitis C
9. Any severe herpes infection at any time prior to randomization
10. Opportunistic infection requiring hospitalisation or parenteral antimicrobial treatment within 3 years prior to randomization (vaginal, oral and skin candidiasis is not an exclusionreason).
11. 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
12. Concurrent enrolment in another clinical study with an IP within 4 weeks prior to ICF signing or within 5 half-lives of the IP used in that clinical study, whichever is longer.
13. During screening (within 30 days before Day 1 \[Week 0 visit\]), any of the following:
1. Aspartate transaminase (AST) \>2.5×upper limit of normal (ULN)
2. Alanine transaminase (ALT) \>2.5×ULN
3. Total bilirubin \>ULN (unless due to Gilbert's syndrome \[based on Investigator's judgement\])
4. Glycosylated haemoglobin (HbA1c) \>8% (or \>0.08) at screening (diabetic subjects only)
5. Neutrophil count \<1x103/μL (or \<1.0 GI/L)
6. Platelet count \<25x103/μL (or \<25 GI/L)
7. Haemoglobin \<8 g/dL (or \<80 g/L).
18 Years
70 Years
ALL
No
Sponsors
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Parexel
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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AstraZeneca AB
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Glendale, Arizona, United States
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Phoenix, Arizona, United States
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La Jolla, California, United States
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Los Angeles, California, United States
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Thousand Oaks, California, United States
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Aurora, Colorado, United States
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DeBary, Florida, United States
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Boston, Massachusetts, United States
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Newark, New Jersey, United States
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Great Neck, New York, United States
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New Hyde Park, New York, United States
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New York, New York, United States
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New York, New York, United States
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The Bronx, New York, United States
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Columbus, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Memphis, Tennessee, United States
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Buenos Aires, , Argentina
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Córdoba, , Argentina
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Rosario, , Argentina
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Adelaide, , Australia
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Clayton, , Australia
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Parkville, , Australia
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Westmead, , Australia
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Brussels, , Belgium
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Brussels, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
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Bordeaux, , France
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Marseille, , France
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Paris, , France
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Strasbourg, , France
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Toulouse, , France
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Berlin, , Germany
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Kiel, , Germany
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Budapest, , Hungary
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Debrecen, , Hungary
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Kaposvár, , Hungary
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Szeged, , Hungary
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Milan, , Italy
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Padua, , Italy
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Pisa, , Italy
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Reggio Emilia, , Italy
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Chihuahua City, , Mexico
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Guadalajara, , Mexico
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Guadalajara, , Mexico
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México, , Mexico
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San Luis Potosí City, , Mexico
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Arequipa, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Krakow, , Poland
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Lodz, , Poland
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Warsaw, , Poland
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Orenburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Belgrade, , Serbia
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Belgrade, , Serbia
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Niš, , Serbia
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Novi Sad, , Serbia
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Gwangju, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Suwon, , South Korea
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Barcelona, , Spain
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Barcelona, , Spain
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Changhua, , Taiwan
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Kaohsiung City, , Taiwan
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Taichung, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
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Taoyuan, , Taiwan
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London, , United Kingdom
Countries
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References
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Jayne D, Rovin B, Mysler E, Furie R, Houssiau F, Trasieva T, Knagenhjelm J, Schwetje E, Tang W, Tummala R, Lindholm C. Anifrolumab in lupus nephritis: results from second-year extension of a randomised phase II trial. Lupus Sci Med. 2023 Aug;10(2):e000910. doi: 10.1136/lupus-2023-000910.
Jayne D, Rovin B, Mysler EF, Furie RA, Houssiau FA, Trasieva T, Knagenhjelm J, Schwetje E, Chia YL, Tummala R, Lindholm C. Phase II randomised trial of type I interferon inhibitor anifrolumab in patients with active lupus nephritis. Ann Rheum Dis. 2022 Apr;81(4):496-506. doi: 10.1136/annrheumdis-2021-221478. Epub 2022 Feb 10.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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D3461C00007
Identifier Type: -
Identifier Source: org_study_id