BridgeMD
A Study to Evaluate the Treatment Outcomes of Subcutaneous Anifrolumab in Immunosuppressant-naïve and Biologic-naïve Systemic Lupus Erythematosus
EU CTIS ID: 2025-523670-17-00
What this study is testing
To describe the attainment of DORIS remission in IS-naïve and biologic-naïve participants with Systemic Lupus Erythematous (SLE) on antimalarials with or without (glucocorticoid) GC, initiated on anifrolumab
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Males or females aged 18 to 70 years of age inclusive at the time of sigining the ICF
- 2. Participants who have a diagnosis of SLE, confirmed by a rheumatologist, for at least 3 months (≥ 12 weeks) prior to signing the ICF (SLE according to the 2019 EULAR/American College of Rheumatology (ACR) criteria)
- 3. ANA-positive as determined by a documented historical test result confirmed at Screening for Antinuclear antibody (ANA) immunofluorescent assay test (titre ≥ 1:80) or at least one of the following determined at screening: (a) ANA (b) Anti-dsDNA (c) Anti-Smith (anti-Sm)
- 4. Must be receiving the standard therapy regimen: antimalarials with or without OCSs
- 5. Must have at screening and baseline: (a) Clinical SLEDAI-2K ≥ 4 points OR (b) Clinical SLEDAI-2K < 4 with GC dose ≥ 7.5 mg/day (prednisone equivalent)
- Additional details on inclusion criteria are described in protocol section 5.1 Inclusion Criteria
You likely can't join if
- 1. History of, or current diagnosis of, a clinically significant non-SLE-related vasculitis syndrome .
- 10. Confirmed positive test for hepatitis B serology
- 11. Active hepatitis C infection
- 12. Clinical cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection that has not completely resolved within 12 weeks prior to signing the ICF
- 13. Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years of Week 0 (Day 1)
- 14. Clinically significant chronic infection within 8 weeks prior to signing the ICF
See the full eligibility criteria
- 1. Males or females aged 18 to 70 years of age inclusive at the time of sigining the ICF
- 2. Participants who have a diagnosis of SLE, confirmed by a rheumatologist, for at least 3 months (≥ 12 weeks) prior to signing the ICF (SLE according to the 2019 EULAR/American College of Rheumatology (ACR) criteria)
- 3. ANA-positive as determined by a documented historical test result confirmed at Screening for Antinuclear antibody (ANA) immunofluorescent assay test (titre ≥ 1:80) or at least one of the following determined at screening: (a) ANA (b) Anti-dsDNA (c) Anti-Smith (anti-Sm)
- 4. Must be receiving the standard therapy regimen: antimalarials with or without OCSs
- 5. Must have at screening and baseline: (a) Clinical SLEDAI-2K ≥ 4 points OR (b) Clinical SLEDAI-2K < 4 with GC dose ≥ 7.5 mg/day (prednisone equivalent)
- Additional details on inclusion criteria are described in protocol section 5.1 Inclusion Criteria
- 1. History of, or current diagnosis of, a clinically significant non-SLE-related vasculitis syndrome .
- 10. Confirmed positive test for hepatitis B serology
- 11. Active hepatitis C infection
- 12. Clinical cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection that has not completely resolved within 12 weeks prior to signing the ICF
- 13. Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years of Week 0 (Day 1)
- 14. Clinically significant chronic infection within 8 weeks prior to signing the ICF
- 15. Severe Herpes Zostet (HZ) or recurrent HZ
- 16. Malignancy. History of cancer
- 2. Subjects with antiphospholipid antibody syndrome on stable anticoagulant therapy at an effective dose are allowed if this is not the sole or the predominant feature of their SLE. Subjects with a serious thrombotic event or unexplained pregnancy loss within 1 year before the screening visit are excluded.
- 3.Subjects with a history of catastrophic antiphospholipid syndrome or saddle embolism are excluded. Subjects with a history of 3 or more unexplained consecutive pregnancy losses would also be excluded.
- 4. History or evidence of suicidal ideation (severity of 4 or 5) within the past 6 months; or any suicidal behavior within the past 12 months or recurrent suicidal behavior in the lifetime of the participant
- 5. Active severe or unstable neuropsychiatric SLE
- 6. Active severe SLE-driven renal disease where protocol-specified standard therapy is insufficient
- 7. History of, or current diagnosis of, catastrophic antiphospholipid syndrome (APS) within one year prior to signing the ICF.
- 8. History of recurrent infection requiring hospitalization and IV antibiotics
- 9. Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection, or a positive result for human immunodeficiency virus (HIV) infection confirmed by central laboratory at Screening.
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- Taiwan
- Canada
- United States
- Mexico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; Taiwan; Canada; United States; Mexico. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.