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JRCT ID: jRCT2071210076

Registered date:15/10/2021

A Multicentre, Randomised, Double-Blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedSystemic Lupus Erythematosus
Date of first enrollment03/03/2022
Target sample size36
Countries of recruitmentUnited States,Japan,Argentina,Japan,Bulgaria,Japan,Chile,Japan,Colombia,Japan,Hungary,Japan,Mexico,Japan,Peru,Japan,Poland,Japan,Russia,Japan,Ukraine,Japan,United Kingdom,Japan,Germany,Japan,Spain,Japan
Study typeInterventional
Intervention(s)Approximately 360 patients are planned to be randomly assigned in a 1:1 ratio (180 patients per treatment group) to receive either a fixed SC dose of anifrolumab or placebo once weekly (QW).


Primary OutcomeBritish Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response [ Time Frame: At week 52 ] BICLA response is a composite binary endpoint whereby responders are defined by meeting all of the following criteria: - Improvement from baseline in disease activity as measured by BILAG-2004. Improvement is defined as a 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, where worsening is defined as 1 new BILAG-2004 A or more or 2 new BILAG 2004 B or more. - No worsening from baseline in SLEDAI-2K, where worsening is defined as an increase from baseline of > 0 points in SLEDAI-2K. - No worsening from baseline in the patient's lupus disease activity, where worsening is defined as an increase 0.30 points or more on a 3-point PGA VAS.
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximum<= 70age old
Include criteria1. Patients who have a diagnosis of pediatric or adult SLE according to the ACR 1997 revised criteria for 24 weeks prior or more to signing the ICF 2. To be eligible a patient must have SLEDAI-2K 6 points or more and "Clinical" SLEDAI-2K score 4 points or more at screening 3. BILAG2004 with at least 1 of the following: - BILAG2004 level A disease in 1 organ system or more - BILAG2004 level B disease in 2 organ systems or more 4. Physician's Global Assessment (PGA) score 1.0 or more on a 0 to 3 VAS at Screening 5. Antinuclear antibody, and/or Anti-dsDNA and/oranti-Smith positive at Screening, 6. Must be on stable background standard therapy with DMARD, glucocorticoids or anti-malarials alone or in combinations.
Exclude criteria7. Active severe or unstable neuropsychiatric SLE 8. Active severe SLE-driven renal disease 9. 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. 10. History of recurrent infection requiring hospitalization and IV antibiotics (eg, 3 or more of the same type of infection over the previous 52 weeks). 11. Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the patient to infection, or a positive result for human immunodeficiency virus (HIV) infection confirmed by central laboratory at Screening. 12. At Screening, confirmed positive test for hepatitis B serology and positive test for hepatitis C antibody 13. Any severe case herpes zoster infection at any time prior to Week 0 (Day 1), 14. Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years of randomization. 15. History of cancer, apart from: a. Squamous or basal cell carcinoma of the skin treated with documented success of curative therapy 3 months prior or more to Week 0 (Day 1) b. Cervical cancer in situ treated with apparent success with curative therapy 1 year prior or more to Week 0 (Day 1).

Related Information


Public contact
Name Kazushige Hibi
Address 3-1, Ofuka-cho, Kita-ku, Osaka-shi Osaka Japan 530-0011
Telephone +81-6-4802-3533
Affiliation Astrazeneka K.K
Scientific contact
Name Kazushige Hibi
Address 3-1, Ofuka-cho, Kita-ku, Osaka-shi Osaka Japan 530-0011
Telephone +81-6-4802-3533
Affiliation Astrazeneka K.K