Actively Recruiting
An Efficacy and Safety Study of Intravenous Anifrolumab to Treat Systemic Lupus Erythematosus in Pediatric Participants
Led by AstraZeneca · Updated on 2026-05-06
100
Participants Needed
98
Research Sites
303 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), Efficacy, and Safety of Anifrolumab in Children with Moderate to Severe Active Systemic Lupus Erythematosus (SLE)
CONDITIONS
Official Title
An Efficacy and Safety Study of Intravenous Anifrolumab to Treat Systemic Lupus Erythematosus in Pediatric Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Parent or legal guardian and participant able to give informed consent/assent as required
- Diagnosis of systemic lupus erythematosus per 2019 criteria for at least 3 months before consent
- No signs or symptoms of active tuberculosis and no recent TB exposure without treatment
- Negative pregnancy tests for females of childbearing potential at screening and randomization
- Adherence to contraception methods by females of childbearing potential and males
You will not qualify if you...
- Diagnosis of interferon-mediated autoinflammatory interferonopathy
- History or current significant non-SLE vasculitis
- For participants 11 years and older: history or signs of suicidal ideation
- Use of corticosteroids for non-SLE disease over 2 weeks within 24 weeks before consent
- Positive HIV test
- Active hepatitis B or C infection or recent Herpes Zoster infection
- Ongoing cytomegalovirus or Epstein-Barr virus infection within 12 weeks before consent
- History of severe COVID-19 infection requiring hospitalization or unresolved symptoms
- Prior use of anifrolumab
- Treatment with B-cell depleting agents like rituximab within 26 weeks before consent
- Blood transfusion or blood products (except albumin) within 4 weeks before consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 98 locations
1
Research Site
Phoenix, Arizona, United States, 85016
Actively Recruiting
2
Research Site
Los Angeles, California, United States, 90027
Actively Recruiting
3
Research Site
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
4
Research Site
Chicago, Illinois, United States, 60611
Actively Recruiting
5
Research Site
Chicago, Illinois, United States, 60637
Actively Recruiting
6
Research Site
New Orleans, Louisiana, United States, 70118
Not Yet Recruiting
7
Research Site
Bethesda, Maryland, United States, 20889
Withdrawn
8
Research Site
Saint Paul, Minnesota, United States, 55125
Actively Recruiting
9
Research Site
New Hyde Park, New York, United States, 11042
Actively Recruiting
10
Research Site
New York, New York, United States, 10032
Actively Recruiting
11
Research Site
The Bronx, New York, United States, 10467
Actively Recruiting
12
Research Site
Valhalla, New York, United States, 10595
Actively Recruiting
13
Research Site
Durham, North Carolina, United States, 27710
Actively Recruiting
14
Research Site
Cincinnati, Ohio, United States, 45229
Actively Recruiting
15
Research Site
Cleveland, Ohio, United States, 44109
Actively Recruiting
16
Research Site
Columbus, Ohio, United States, 43203
Actively Recruiting
17
Research Site
Portland, Oregon, United States, 97227
Actively Recruiting
18
Research Site
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
19
Research Site
Greenville, South Carolina, United States, 29605
Withdrawn
20
Research Site
El Paso, Texas, United States, 79902
Actively Recruiting
21
Research Site
Houston, Texas, United States, 77030
Actively Recruiting
22
Research Site
Salt Lake City, Utah, United States, 84108
Actively Recruiting
23
Research Site
Buenos Aires, Argentina, C1270
Withdrawn
24
Research Site
Córdoba, Argentina, 5000
Actively Recruiting
25
Research Site
Rosario, Argentina, S2000PBJ
Actively Recruiting
26
Research Site
San Miguel de Tucumán, Argentina, T4000AXL
Not Yet Recruiting
27
Research Site
Porto Alegre, Brazil, 90035-903
Actively Recruiting
28
Research Site
Ribeirão Preto, Brazil, 14048-900
Actively Recruiting
29
Research Site
São Paulo, Brazil, 04024-002
Actively Recruiting
30
Research Site
São Paulo, Brazil, 05403 000
Actively Recruiting
31
Research Site
Calgary, British Columbia, Canada, T2N 4N1
Not Yet Recruiting
32
Research Site
Vancouver, British Columbia, Canada, V6H 3N1
Actively Recruiting
33
Research Site
Toronto, Ontario, Canada, M5G 1X8
Actively Recruiting
34
Research Site
Beijing, China, 100020
Withdrawn
35
Research Site
Beijing, China, 100032
Not Yet Recruiting
36
Research Site
Beijing, China, 100730
Actively Recruiting
37
Research Site
Changchun, China, 130021
Actively Recruiting
38
Research Site
Changsha, China, 410007
Actively Recruiting
39
Research Site
Nanjing, China, 210008
Not Yet Recruiting
40
Research Site
Shanghai, China, 201102
Actively Recruiting
41
Research Site
Suzhou, China, 215002
Actively Recruiting
42
Research Site
Wenzhou, China, 325027
Actively Recruiting
43
Research Site
Zhengzhou, China, 450018
Actively Recruiting
44
Research Site
Barranquilla, Colombia, 01800
Actively Recruiting
45
Research Site
Medellín, Colombia, 050034
Withdrawn
46
Research Site
Bordeaux, France, 33076
Actively Recruiting
47
Research Site
Bron, France, 69677
Actively Recruiting
48
Research Site
Le Kremlin-Bicêtre, France, 94275
Actively Recruiting
49
Research Site
Lille, France, 59037
Actively Recruiting
50
Research Site
Toulouse, France, 31300
Actively Recruiting
51
Research Site
Berlin, Germany, D-13353
Actively Recruiting
52
Research Site
Freiburg im Breisgau, Germany, 79106
Actively Recruiting
53
Research Site
Sankt Augustin, Germany, 53757
Actively Recruiting
54
Research Site
Genova, Italy, 16148
Actively Recruiting
55
Research Site
Milan, Italy, 20122
Actively Recruiting
56
Research Site
Milan, Italy, 20122
Not Yet Recruiting
57
Research Site
Padova, Italy, 35128
Actively Recruiting
58
Research Site
Roma, Italy, 00165
Actively Recruiting
59
Research Site
Bunkyō City, Japan, 113-8519
Actively Recruiting
60
Research Site
Bunkyō City, Japan, 113-8603
Actively Recruiting
61
Research Site
Chiba, Japan, 266-0007
Actively Recruiting
62
Research Site
Fuchu-shi, Japan, 183-8561
Actively Recruiting
63
Research Site
Kawasaki-shi, Japan, 216-8511
Actively Recruiting
64
Research Site
Kobe, Japan, 650-0047
Actively Recruiting
65
Research Site
Obu-shi, Japan, 474-8710
Actively Recruiting
66
Research Site
Shinjuku-ku, Japan, 162-8666
Actively Recruiting
67
Research Site
Yokohama, Japan, 232 8555
Actively Recruiting
68
Research Site
Yokohama, Japan, 236-0004
Actively Recruiting
69
Research Site
Atizapán de Zaragoza, Mexico, 52937
Not Yet Recruiting
70
Research Site
Guadalajara, Mexico, 44620
Actively Recruiting
71
Research Site
Mérida, Mexico, 97070
Actively Recruiting
72
Research Site
México, Mexico, 06720
Actively Recruiting
73
Research Site
Monterrey, Mexico, 64460
Actively Recruiting
74
Research Site
Lodź, Poland, 91-738
Actively Recruiting
75
Research Site
Warsaw, Poland, 02-637
Actively Recruiting
76
Research Site
Wroclaw, Poland, 52-114
Actively Recruiting
77
Research Site
Lisbon, Portugal, 1169-045
Withdrawn
78
Research Site
Lisbon, Portugal, 1649-035
Withdrawn
79
Research Site
Porto, Portugal, 4200-319
Withdrawn
80
Research Site
Cape Town, South Africa, 7700
Withdrawn
81
Research Site
Esplugues de Llobregat, Spain, 8950
Actively Recruiting
82
Research Site
Madrid, Spain, 28009
Actively Recruiting
83
Research Site
Madrid, Spain, 28034
Actively Recruiting
84
Research Site
Madrid, Spain, 28046
Not Yet Recruiting
85
Research Site
Málaga, Spain, 29011
Actively Recruiting
86
Research Site
Santiago de Compostela, Spain, 15706
Not Yet Recruiting
87
Research Site
Valencia, Spain, 46026
Actively Recruiting
88
Research Site
Ankara, Turkey (Türkiye), 06230
Actively Recruiting
89
Research Site
Istanbul, Turkey (Türkiye), 34098
Actively Recruiting
90
Research Site
Kayseri, Turkey (Türkiye), 38039
Actively Recruiting
91
Research Site
Umraniye, Turkey (Türkiye), 34760
Actively Recruiting
92
Research Site
Birmingham, United Kingdom, B4 6NH
Actively Recruiting
93
Research Site
Bristol, United Kingdom, BS2 8BJ
Actively Recruiting
94
Research Site
Liverpool, United Kingdom, L12 2AP
Actively Recruiting
95
Research Site
London, United Kingdom, NW1 2PG
Actively Recruiting
96
Research Site
London, United Kingdom, WC1N 3JH
Actively Recruiting
97
Research Site
Manchester, United Kingdom, M13 9WL
Actively Recruiting
98
Research Site
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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