A Study to Characterize the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab in Adult Type I Interferon Test High Systemic Lupus Erythematosus Subject With Active Skin Manifestations
NCT ID: NCT02962960
Last Updated: 2023-01-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
36 participants
INTERVENTIONAL
2017-02-14
2018-12-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Anifrolumab - Lower dose
1ml, once every second week, one subcutaneous injection as added to stand of care, from week 0 to week 50
Anifrolumab
subcutaneous administration every 2 weeks from week 0 to week 50
Placebo matching for lower dose of Anifrolumab
1ml, once every second week, one subcutaneous injection added to stand of care, from week 0 to week 50
Placebo
subcutaneous administration every two weeks from week 0 to week 50
Anifrolumab - Higher dose
2×1ml, once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50
Anifrolumab
subcutaneous administration every 2 weeks from week 0 to week 50
Placebo matching for higher dose of Anifrolumab
2×1ml , once every second week, two subcutaneous injections as added to stand of care, from week 0 to week 50
Placebo
subcutaneous administration every two weeks from week 0 to week 50
Interventions
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Anifrolumab
subcutaneous administration every 2 weeks from week 0 to week 50
Placebo
subcutaneous administration every two weeks from week 0 to week 50
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of paediatric or adult SLE for \> 24 weeks and fulfilling ≥4 of the 11 American College of Rheumatology (ACR) classification criteria with at least one being:
* Positive antinuclear antibody (ANA) or
* Elevated anti-dsDNA antibodies or
* anti-Smith (anti-Sm) antibodies
3. Interferon high test result
4. Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score ≥ 10
5. Currently receiving at least 1 of the following for treatment of SLE:
• Oral prednisone or equivalent of ≤40 mg/day for a minimum of 2 weeks prior to signing the Informed Consent Form (ICF) and with stable dose for at least 2 weeks prior to randomization
• Any of the following medications for at least 12 weeks prior to signing the ICF, and at a stable doses for at least 8 weeks prior to randomization: (i) Azathioprine ≤200 mg/day (ii) Antimalarials (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
6. Must not have signs of active or latent tuberculosis (TB).
7. Must not be pregnant or breastfeeding.
Exclusion Criteria
2. Active severe SLE-driven renal disease
3. Any severe herpes infection at any time
4. Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or HIV infection.
5. Known history of a primary immunodeficiency (splenectomy, or any underlying condition predisposing for infection
6. Receipt of any investigation product within 4 weeks or 5 half -lives prior to signing of the ICF
7. History of cancer, apart from:
* Squamous or basal cell carcinoma of the skin if successfully treated.
* Cervical cancer in situ if successfully treated
18 Years
70 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Thousand Oaks, California, United States
Research Site
Orlando, Florida, United States
Research Site
New York, New York, United States
Research Site
Charlotte, North Carolina, United States
Research Site
Memphis, Tennessee, United States
Research Site
Houston, Texas, United States
Research Site
Debrecen, , Hungary
Research Site
Zalaegerszeg, , Hungary
Research Site
Bydgoszcz, , Poland
Research Site
Warsaw, , Poland
Research Site
Anyang-si, , South Korea
Research Site
Busan, , South Korea
Research Site
Daegu, , South Korea
Research Site
Gwangju, , South Korea
Countries
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References
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Bruce IN, Nami A, Schwetje E, Pierson ME, Rouse T, Chia YL, Kuruvilla D, Abreu G, Tummala R, Lindholm C. Pharmacokinetics, pharmacodynamics, and safety of subcutaneous anifrolumab in patients with systemic lupus erythematosus, active skin disease, and high type I interferon gene signature: a multicentre, randomised, double-blind, placebo-controlled, phase 2 study. Lancet Rheumatol. 2021 Feb;3(2):e101-e110. doi: 10.1016/S2665-9913(20)30342-8. Epub 2020 Nov 20.
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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D3461C00008
Identifier Type: -
Identifier Source: org_study_id
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