Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus (NCT04877691) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus
United States, Argentina, Bulgaria367 participantsStarted 2021-06-08
Plain-language summary
The purpose of this study is evaluating the efficacy and safety of SC antifrolumab in adult patients with moderate -to-severe SLE despite receiving standard therapy
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients who have a diagnosis of pediatric or adult SLE according to the ACR 1997 revised criteria for ≥ 24 weeks prior to signing the ICF
. To be eligible a patient must have SLEDAI-2K ≥ 6 points and "Clinical" SLEDAI-2K score ≥4 points at screening
. BILAG2004 with at least 1 of the following:
. BILAG2004 level A disease in ≥ 1 organ system
. BILAG2004 level B disease in ≥ 2 organ systems
. Physician's Global Assessment (PGA) score ≥ 1.0 on a 0 to 3 VAS at Screening
. Antinuclear antibody, and/or Anti-dsDNA and/oranti-Smith positive at Screening,
. Must be on stable background standard therapy with DMARD, glucocorticoids or anti-malarials alone or in combinations.
Exclusion criteria
. Active severe or unstable neuropsychiatric SLE
. Active severe SLE-driven renal disease
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response
. 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.
0. History of recurrent infection requiring hospitalization and IV antibiotics (eg, 3 or more of the same type of infection over the previous 52 weeks).
1. 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.
2. At Screening, confirmed positive test for hepatitis B serology and positive test for hepatitis C antibody
3. Any severe case herpes zoster infection at any time prior to Week 0 (Day 1),
4. Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years of randomization.