For Healthcare Professionals

Anifrolumab Asian PhIII Efficacy Study for Systemic Lupus Erythematosus (SLE)

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About the study

The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment regimen of anifrolumab versus placebo in Asian participants with active systemic lupus erythematosus (SLE).
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. Aged 18 to 70 years.
  2. Body weight ≥ 40 kg.
  3. Confirmed diagnosis of SLE(1997 ACR revised criteria) for ≥ 24 weeks.
  4. Must be receiving at least one of the following SOC regimens at screening:
  5. oral prednisone monotherapy: ≥ 7.5 mg/day and ≤ 40 mg/day, stable for > 2 weeks;
  6. Immunosuppressant(s) with or without OCS: antimalarials, AZA, MMF, MTX, mizoribine permitted; stable for ≥ 8 weeks; maximum dose required;
  7. Oral prednisone plus immunosuppressant: start date, stability and maximum dose required.
  8. At least one of these antibodies positive: ANA, anti-dsDNA and anti-Smith.
  9. SLEDAI-2K score ≥ 6 points at screening and "Clinical" SLEDAI-2K score ≥4 points at both screening and Day1(randomisation), and BILAG with at least 1 level A organ system or 2 level B organ system, and PGA score ≥ 1.0 at screening.
  10. Chest imaging shows no clinically significant abnormalities (unless due to SLE).
  11. No evidence or medical history of active TB, indeterminate TB should be referred to a TB specialist.
  12. All participants should use effective contraception methods as protocol requests.
  13. Any negative SARS-CoV-2 RT-PCR test result at screening and no known or suspected COVID-19 infection or exposure within 2 weeks prior to screening and between screening and randomisation visits. Key

EXCLUSION CRITERIA

  1. History or current diagnose of clinically significant non-SLE related vasculitis, severe or unstable neuropsychiatric SLE, active severe SLE-driven renal disease, catastrophic anti-phospholipid syndrome, inflammatory joint or skin disease other than SLE, non-SLE disease that has required treatment of certain dosage of corticosteroid.
  2. History or evidence of suicidal ideation or suicidal behavior.
  3. History or current diagnose of MTCD or overlap syndrome, unless overlap with RA or MTCD which has developed into SLE.
  4. History of recurrent infection requiring hospitalization and IV antibiotics, or opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years of randomization, or clinically significant chronic infection within 3 months, or recent infection still under treatment.
  5. History of immunodeficient condition, HIV positive included.
  6. Confirmed HBsAg positive, or HBcAb positive and HBV DNA detectable, or hepatitis C antibody positive.
  7. History of severe case of herpes zoster.
  8. Herpes zoster, CMV or EB infection which has not completely resolved within 12 weeks before screening.
  9. Acute COVID-19 infection or history of severe COVID-19.
  10. History of cancer, apart from cured squamous or basal cell carcinoma and cervical cancer in situ.
  11. Women participants with abnormal pap smear results.
  12. Prior receipt of anifrolumab ,or any commercially available biologic agent, or protein kinase inhibitor or any investigational product within 5 half-lives, including B cell-depleting therapy, belimumab, JAK or BTK inhibitor.
  13. Known history of allergy to any component of the IP formulation or protein related products.
  14. Receipt of any of the following:
  15. Intramuscular or IV glucocorticosteroids within 6 weeks;
  16. Any live or attenuated vaccine within 8 weeks;
  17. Any restricted medication listed in protocol;
  18. Blood transfusion within 4 weeks. 15 Regular use of > 1 NSAID within 2 weeks or receipt of fluctuating doses of a NSAID within 2 weeks.
  19. Certain laboratory test results requirements. 17. Concurrent enrolment in another clinical study. 18. History or current alcohol, drug or chemical abuse within 1 year. 19. Major surgery within 8 weeks or planned elective major surgery.
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 1-877-240-9479Email iconEmail Study Center

Study’s details


Contition

Active Systemic Lupus Erythematosus

Age

18+

Phase

Phase 3

Participants needed

328

Est. Completion Date

Jun 2025

Treatment type

Interventional


Sponsor

AstraZeneca

ClinicalTrials.gov identifier

NCT04931563

Study number

D3468C00003

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