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
- Conditions
- Systemic Lupus Erythematosus
- Registration Number
- JPRN-jRCT2071210076
- Lead Sponsor
- Hibi Kazushige
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 36
1. 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.
7. 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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method