Actively Recruiting
A Study to Evaluate the Treatment Outcomes of Subcutaneous Anifrolumab in Immunosuppressant-naïve and Biologic-naïve Systemic Lupus Erythematosus
Led by AstraZeneca · Updated on 2026-05-05
245
Participants Needed
73
Research Sites
145 weeks
Total Duration
On this page
Sponsors
A
AstraZeneca
Lead Sponsor
I
ICON plc
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of the SUNFLOWER study is to describe clinical outcomes, including DORIS remission, achieved following the initiation of anifrolumab 120 mg SC once weekly (QW) as add-on therapy to an anti-malarial, with or without GC; in patients not in LLDAS at enrolment. Patients will be naïve to any prior conventional immunosuppressant including prior biologic therapy at enrolment. The study will also employ a tapering protocol for a systematic approach to GC tapering, seeking to understand better the proportion of patients in remission who can successfully withdraw chronic GC completely.
CONDITIONS
Official Title
A Study to Evaluate the Treatment Outcomes of Subcutaneous Anifrolumab in Immunosuppressant-naïve and Biologic-naïve Systemic Lupus Erythematosus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged 18 to 70 years of age.
- Diagnosis of systemic lupus erythematosus (SLE) confirmed by a rheumatologist.
- Positive ANA, anti-dsDNA, or anti-Smith antibody per central lab screening.
- Currently on antimalarial therapy with or without oral corticosteroids (OCSs).
- Clinical SLEDAI-2K score of 4 or more OR SLEDAI-2K less than 4 with glucocorticoid dose of 7.5 mg/day or higher.
- No evidence of active infection or previous tuberculosis.
- No evidence of malignancy or clinically significant abnormalities unless due to SLE.
- No current or prior active tuberculosis.
- Body weight 40 kg or more.
- Negative pregnancy test for females during screening.
- Normal HPV test result within 2 years prior to study start.
- Willing and able to complete all study evaluations and patient-reported outcomes.
- Agree to avoid other experimental treatments during the study.
You will not qualify if you...
- History or current diagnosis of significant non-SLE vasculitis syndrome.
- Antiphospholipid antibody syndrome on stable anticoagulant therapy only if not the main SLE feature.
- Serious thrombotic events or unexplained pregnancy loss within 1 year before screening.
- History of catastrophic antiphospholipid syndrome or saddle embolism.
- Three or more unexplained consecutive pregnancy losses.
- History of suicidal ideation or behavior within specified recent periods.
- Active severe or unstable neuropsychiatric SLE insufficiently controlled by standard therapy.
- Active severe SLE-driven renal disease insufficiently controlled by standard therapy.
- Current diagnosis of catastrophic antiphospholipid syndrome.
- History of recurrent infections requiring hospitalization and IV antibiotics.
- Known primary immunodeficiency, splenectomy, or conditions predisposing to infection.
- Positive HIV test at screening.
- Positive hepatitis B test.
- Recent clinical CMV or EBV infection not fully resolved.
- Opportunistic infection requiring hospitalization or IV treatment within 3 years.
- Clinically significant chronic infections within 8 weeks before consent.
- Severe or recurrent herpes zoster.
- History of malignancy except certain skin and cervical cancers treated successfully.
- Prior use of SLE therapies other than antimalarials and glucocorticoids.
- Allergy or anaphylaxis to study drug components or human gamma globulin therapies.
- Receipt of live or attenuated vaccine within 8 weeks before consent.
- Blood transfusion except albumin.
- Use of more than two investigational SLE products since diagnosis.
- Use of investigational products within 4 weeks or 5 half-lives before consent.
- Enrollment in another clinical study with an intervention.
- Abnormal lab results as specified in protocol.
- Other autoimmune diseases or SLE overlap syndromes.
- Non-SLE illnesses likely needing systemic glucocorticoids during study.
- Conditions interfering with study outcomes or participant safety.
- Lactating, breastfeeding, pregnant, or planning pregnancy during study and follow-up.
- Recent pregnancy or childbirth within 4 weeks before consent.
- Current or recent substance abuse.
- Major surgery within 8 weeks before consent or planned during study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 73 locations
1
Research Site
Anniston, Alabama, United States, 36207
Withdrawn
2
Research Site
Phoenix, Arizona, United States, 85032
Not Yet Recruiting
3
Research Site
Fontana, California, United States, 92335
Not Yet Recruiting
4
Research Site
La Palma, California, United States, 90623
Not Yet Recruiting
5
Research Site
Menifee, California, United States, 92586
Actively Recruiting
6
Research Site
San Leandro, California, United States, 94578
Not Yet Recruiting
7
Research Site
Temecula, California, United States, 92592
Actively Recruiting
8
Research Site
Miami, Florida, United States, 33145
Not Yet Recruiting
9
Research Site
Miami, Florida, United States, 33180
Suspended
10
Research Site
Willowbrook, Illinois, United States, 60527
Not Yet Recruiting
11
Research Site
New Albany, Indiana, United States, 47150
Not Yet Recruiting
12
Research Site
Kansas City, Missouri, United States, 64151
Not Yet Recruiting
13
Research Site
Oklahoma City, Oklahoma, United States, 73116
Actively Recruiting
14
Research Site
Memphis, Tennessee, United States, 38104
Not Yet Recruiting
15
Research Site
Memphis, Tennessee, United States, 38119
Actively Recruiting
16
Research Site
Austin, Texas, United States, 78745
Not Yet Recruiting
17
Research Site
Baytown, Texas, United States, 77521
Not Yet Recruiting
18
Research Site
Colleyville, Texas, United States, 76034
Not Yet Recruiting
19
Research Site
Edinburg, Texas, United States, 78550
Not Yet Recruiting
20
Research Site
Houston, Texas, United States, 77054
Not Yet Recruiting
21
Research Site
Spokane, Washington, United States, 99204
Not Yet Recruiting
22
Research Site
Calgary, Alberta, Canada, T2T 5C7
Not Yet Recruiting
23
Research Site
Winnipeg, Manitoba, Canada, R3A 1M4
Not Yet Recruiting
24
Research Site
Hamilton, Ontario, Canada, L8N 3Z5
Not Yet Recruiting
25
Research Site
Toronto, Canada, M5T 2S8
Not Yet Recruiting
26
Research Site
Clermont-Ferrand, France, 63000
Not Yet Recruiting
27
Research Site
Paris, France, 75012
Not Yet Recruiting
28
Research Site
Paris, France, 75013
Not Yet Recruiting
29
Research Site
Vandœuvre-lès-Nancy, France, 54511
Not Yet Recruiting
30
Research Site
Hamburg, Germany, 22763
Not Yet Recruiting
31
Research Site
Mainz, Germany, 55131
Not Yet Recruiting
32
Research Site
München, Germany, 80336
Not Yet Recruiting
33
Research Site
Brescia, Italy, 25123
Not Yet Recruiting
34
Research Site
Catania, Italy, 95123
Not Yet Recruiting
35
Research Site
Ferrara, Italy, 44121
Not Yet Recruiting
36
Research Site
Florence, Italy, 50141
Not Yet Recruiting
37
Research Site
Milan, Italy, 20122
Suspended
38
Research Site
Milan, Italy, 20122
Not Yet Recruiting
39
Research Site
Padova, Italy, 35128
Not Yet Recruiting
40
Research Site
Pisa, Italy, 56124
Not Yet Recruiting
41
Research Site
Roma, Italy, 00161
Not Yet Recruiting
42
Research Site
Roma, Italy, 00168
Suspended
43
Research Site
Rozzano, Italy, 20089
Not Yet Recruiting
44
Research Site
Udine, Italy, 33100
Not Yet Recruiting
45
Research Site
Culiacán, Mexico, 80000
Not Yet Recruiting
46
Research Site
Durango, Mexico, 34080
Not Yet Recruiting
47
Research Site
Guadalajara, Mexico, 44160
Not Yet Recruiting
48
Research Site
Guadalajara, Mexico, 44650
Not Yet Recruiting
49
Research Site
Guadalajara, Mexico, 44690
Suspended
50
Research Site
México, Mexico, 03100
Not Yet Recruiting
51
Research Site
México, Mexico, 14080
Not Yet Recruiting
52
Research Site
Bydgoszcz, Poland, 85-065
Not Yet Recruiting
53
Research Site
Krakow, Poland, 30-688
Not Yet Recruiting
54
Research Site
Lodz, Poland, 90-368
Not Yet Recruiting
55
Research Site
Lublin, Poland, 20-607
Not Yet Recruiting
56
Research Site
Nadarzyn, Poland, 05-830
Not Yet Recruiting
57
Research Site
Nowa Sól, Poland, 67-100
Not Yet Recruiting
58
Research Site
Poznan, Poland, 60-693
Not Yet Recruiting
59
Research Site
Poznan, Poland, 61-397
Not Yet Recruiting
60
Research Site
Warsaw, Poland, 05-077
Not Yet Recruiting
61
Research Site
Wroclaw, Poland, 53-673
Not Yet Recruiting
62
Research Site
Córdoba, Spain, 14004
Suspended
63
Research Site
Galdakao, Spain, 48960
Not Yet Recruiting
64
Research Site
Madrid, Spain, 28034
Not Yet Recruiting
65
Research Site
Madrid, Spain, 28046
Not Yet Recruiting
66
Research Site
Sabadell, Spain, 08208
Not Yet Recruiting
67
Research Site
Santander, Spain, 39008
Not Yet Recruiting
68
Research Site
Valencia, Spain, 46026
Not Yet Recruiting
69
Research Site
Kaohsiung City, Taiwan, 813414
Not Yet Recruiting
70
Research Site
Kaohsiung City, Taiwan, 833
Not Yet Recruiting
71
Research Site
Taichung, Taiwan, 40705
Not Yet Recruiting
72
Research Site
Tainan, Taiwan, 70403
Not Yet Recruiting
73
Research Site
Taoyuan, Taiwan, 33305
Not Yet Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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