Phase
Condition
Lupus
Cutaneous Lupus Erythematosus
Systemic Lupus Erythematosus
Treatment
Placebo
Anifrolumab
Clinical Study ID
Ages 5-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant's parent/caregiver/legally authorized representative and participant (ifrequired per local country regulation) capable of giving signed informed consent,which includes compliance with the requirements and restrictions listed in the ICFand in this protocol. Informed assent is to be provided by the participant per localcountry regulation.
Diagnosis of SLE according to the 2019 European League Against Rheumatism/AmericanCollege of Rheumatology (EULAR/ACR) criteria for at least 3 months prior to signingthe ICF.
Participant should meet all of following tuberculosis (TB) criteria:
A. No signs or symptoms of active TB B. No medical history or past physical examinations suggestive of active TB C. No recent contact with a person with active TB or if there has been such contact, referral to a TB specialist for evaluation and initiation of treatment for latent TB, if warranted, prior to the first administration of study intervention in accordance with local SoC D. No history of latent TB without documented completion of treatment prior to initial screening visit
Female participants of childbearing potential must have a negative serum pregnancytest at screening and negative urine pregnancy test at randomization.
Female participants of childbearing and male participants must adhere to thecontraception methods.
Exclusion
Exclusion Criteria:
Known diagnosis of an IFN-mediated autoinflammatory interferonopathy.
History of, or current diagnosis of, clinically significant non-SLE-relatedvasculitides.
In participants aged 11 years and above: history or evidence of suicidal ideation.
History of any non-SLE disease that has required treatment with oral or parenteralcorticosteroids for more than a total of 2 weeks within the last 24 weeks prior tosigning the ICF.
Any positive result on screening for human immunodeficiency virus.
Active hepatitis B surface antigen OR hepatitis B core antibody (HBcAb), hepatitis Cvirus (HCV) antibody and detectable HCV ribonucleic acid (RNA) or any active orrecent case of Herpes Zoster infection.
Any clinical cytomegalovirus or Epstein-Barr virus infection that has not completelyresolved within 12 weeks prior to signing the ICF.
History of severe COVID-19 infection requiring hospitalization, intensive care unitcare, or assisted ventilation or any prior COVID-19 infection with unresolvedsequelae. Any mild/asymptomatic COVID-19 infection (laboratory confirmed orsuspected based on clinical symptoms).
Prior use of anifrolumab.
Prior treatment with directly acting cytotoxic B-cell depleting therapeutics (eg,rituximab) < 26 weeks prior to ICF signature.
Blood transfusion or receipt of blood products except albumin within 4 weeks priorto signing the ICF.
Study Design
Study Description
Connect with a study center
Research Site
Buenos Aires, C1270
ArgentinaSite Not Available
Research Site
Buenos Aires 3435910, C1270
ArgentinaSite Not Available
Research Site
Córdoba, 5000
ArgentinaActive - Recruiting
Research Site
Córdoba 3860259, 5000
ArgentinaSite Not Available
Research Site
Rosario, S2000PBJ
ArgentinaActive - Recruiting
Research Site
Rosario 3838583, S2000PBJ
ArgentinaSite Not Available
Research Site
San Miguel de Tucumán, T4000AXL
ArgentinaSite Not Available
Research Site
San Miguel de Tucumán 3836873, T4000AXL
ArgentinaSite Not Available
Research Site
Botucatu, 18610-070
BrazilSite Not Available
Research Site
Botucatu 3469136, 18610-070
BrazilSite Not Available
Research Site
Curitiba, 80030-110
BrazilSite Not Available
Research Site
Curitiba 3464975, 80030-110
BrazilSite Not Available
Research Site
Porto Alegre, 90035-903
BrazilActive - Recruiting
Research Site
Porto Alegre 3452925, 90035-903
BrazilSite Not Available
Research Site
Ribeirão Preto, 14048-900
BrazilActive - Recruiting
Research Site
Ribeirão Preto 3451328, 14048-900
BrazilSite Not Available
Research Site
Sao Paulo, 04024-002
BrazilSite Not Available
Research Site
São Paulo, 05403 000
BrazilActive - Recruiting
Research Site
São Paulo 3448439, 05403 000
BrazilSite Not Available
Research Site
Calgary 5913490, Alberta 5883102 T3M1M4
CanadaSite Not Available
Research Site
Calgary, British Columbia T2N 4N1
CanadaSite Not Available
Research Site
Vancouver, British Columbia V6H 3N1
CanadaActive - Recruiting
Research Site
Vancouver 6173331, British Columbia 5909050 V6H 3N1
CanadaSite Not Available
Research Site
Toronto, Ontario M5G 1X8
CanadaActive - Recruiting
Research Site
Toronto 6167865, Ontario 6093943 M5G 1X8
CanadaSite Not Available
Research Site
Beijing, 100032
ChinaSite Not Available
Research Site
Beijing 1816670, 100730
ChinaSite Not Available
Research Site
Changchun, 130021
ChinaActive - Recruiting
Research Site
Changchun 2038180, 130021
ChinaSite Not Available
Research Site
Changsha, 410007
ChinaActive - Recruiting
Research Site
Changsha 1815577, 410007
ChinaSite Not Available
Research Site
Nanjing, 210008
ChinaSite Not Available
Research Site
Shanghai, 201102
ChinaActive - Recruiting
Research Site
Shanghai 1796236, 201102
ChinaSite Not Available
Research Site
Suzhou, 215002
ChinaActive - Recruiting
Research Site
Suzhou 1886760, 215002
ChinaSite Not Available
Research Site
Wenzhou, 325027
ChinaActive - Recruiting
Research Site
Wenzhou 1791388, 325027
ChinaSite Not Available
Research Site
Zhengzhou, 450018
ChinaActive - Recruiting
Research Site
Zhengzhou 1784658, 450018
ChinaSite Not Available
Research Site
Barranquilla, 01800
ColombiaActive - Recruiting
Research Site
Barranquilla 3689147, 01800
ColombiaSite Not Available
Research Site
Medellin, 050034
ColombiaSite Not Available
Research Site
Medellín, 050034
ColombiaSite Not Available
Research Site
Medellín 3674962, 050034
ColombiaSite Not Available
Research Site
Bordeaux, 33076
FranceActive - Recruiting
Research Site
Bordeaux 3031582, 33076
FranceSite Not Available
Research Site
Bordeaux Cedex, 33076
FranceSite Not Available
Research Site
Bron, 69677
FranceActive - Recruiting
Research Site
Bron 3029931, 69677
FranceSite Not Available
Research Site
LILLE Cedex, 59037
FranceSite Not Available
Research Site
Le Kremlin Bicetre, 94275
FranceSite Not Available
Research Site
Le Kremlin-Bicêtre, 94275
FranceActive - Recruiting
Research Site
Le Kremlin-Bicêtre 3003737, 94275
FranceSite Not Available
Research Site
Lille, 59037
FranceActive - Recruiting
Research Site
Lille 2998324, 59037
FranceSite Not Available
Research Site
Toulouse, 31300
FranceActive - Recruiting
Research Site
Toulouse 2972315, 31300
FranceSite Not Available
Research Site
Berlin, D-13353
GermanyActive - Recruiting
Research Site
Berlin 2950159, D-13353
GermanySite Not Available
Research Site
Freiburg, 79106
GermanySite Not Available
Research Site
Freiburg im Breisgau, 79106
GermanyActive - Recruiting
Research Site
Freiburg im Breisgau 2925177, 79106
GermanySite Not Available
Research Site
Sankt Augustin, 53757
GermanyActive - Recruiting
Research Site
Sankt Augustin 2841648, 53757
GermanySite Not Available
Research Site
Genova, 16148
ItalyActive - Recruiting
Research Site
Genova 8969657, 16148
ItalySite Not Available
Research Site
Milan, 20122
ItalySite Not Available
Research Site
Milan 6951411, 20122
ItalySite Not Available
Research Site
Milano, 20122
ItalySite Not Available
Research Site
Padova, 35128
ItalyActive - Recruiting
Research Site
Padua 3171728, 35128
ItalySite Not Available
Research Site
Roma, 00165
ItalyActive - Recruiting
Research Site
Roma 8957247, 00165
ItalySite Not Available
Research Site
Bunkyo-ku, 113-8519
JapanSite Not Available
Research Site
Bunkyō City, 113-8519
JapanActive - Recruiting
Research Site
Bunkyō City 11790632, 113-8603
JapanSite Not Available
Research Site
Chiba, 266-0007
JapanActive - Recruiting
Research Site
Chiba 2113015, 266-0007
JapanSite Not Available
Research Site
Fuchu-shi, 183-8561
JapanActive - Recruiting
Research Site
Kawasaki-shi, 216-8511
JapanActive - Recruiting
Research Site
Kobe, 650-0047
JapanActive - Recruiting
Research Site
Kobe 1859171, 650-0047
JapanSite Not Available
Research Site
Kobe-shi, 650-0047
JapanSite Not Available
Research Site
Obu-shi, 474-8710
JapanActive - Recruiting
Research Site
Shinjuku-ku, 162-8666
JapanActive - Recruiting
Research Site
Yokohama, 236-0004
JapanActive - Recruiting
Research Site
Yokohama 1848354, 232 8555
JapanSite Not Available
Research Site
Yokohama-shi, 236-0004
JapanSite Not Available
Research Site
Atizapán de Zaragoza, 52937
MexicoSite Not Available
Research Site
Atizapán de Zaragoza 3482970, 52937
MexicoSite Not Available
Research Site
Guadalajara, 44620
MexicoActive - Recruiting
Research Site
Guadalajara 4005539, 44620
MexicoSite Not Available
Research Site
Merida, 97070
MexicoSite Not Available
Research Site
Mexico, 06720
MexicoSite Not Available
Research Site
Mexico 11095662, 06720
MexicoSite Not Available
Research Site
Monterrey, 64460
MexicoActive - Recruiting
Research Site
Monterrey 3995465, 64460
MexicoSite Not Available
Research Site
Mérida, 97070
MexicoActive - Recruiting
Research Site
Mérida 3523349, 97070
MexicoSite Not Available
Research Site
México, 06720
MexicoActive - Recruiting
Research Site
México 10248874, 06720
MexicoSite Not Available
Research Site
Toluca, 50170
MexicoSite Not Available
Research Site
Toluca 3515302, 50170
MexicoSite Not Available
Research Site
Lodź, 91-738
PolandActive - Recruiting
Research Site
Warsaw, 02-637
PolandActive - Recruiting
Research Site
Warsaw 756135, 02-637
PolandSite Not Available
Research Site
Warszawa, 02-637
PolandSite Not Available
Research Site
Wroclaw, 52-114
PolandActive - Recruiting
Research Site
Wroclaw 3081368, 52-114
PolandSite Not Available
Research Site
Lisboa, 1649-035
PortugalSite Not Available
Research Site
Lisbon, 1649-035
PortugalSite Not Available
Research Site
Lisbon 2267057, 1169-045
PortugalSite Not Available
Research Site
Porto, 4200-319
PortugalSite Not Available
Research Site
Porto 2735943, 4200-319
PortugalSite Not Available
Research Site
Cape Town, 7700
South AfricaSite Not Available
Research Site
Cape Town 3369157, 7700
South AfricaSite Not Available
Research Site
Esplugues de Llobregat, 8950
SpainActive - Recruiting
Research Site
Esplugues de Llobregat 3122826, 8950
SpainSite Not Available
Research Site
Madrid, 28046
SpainSite Not Available
Research Site
Madrid 3117735, 28009
SpainSite Not Available
Research Site
Málaga, 29011
SpainActive - Recruiting
Research Site
Málaga 2514256, 29011
SpainSite Not Available
Research Site
Santiago de Compostela, 15706
SpainSite Not Available
Research Site
Valencia, 46026
SpainActive - Recruiting
Research Site
Valencia 2509954, 46026
SpainSite Not Available
Research Site
Ankara, 06230
TurkeySite Not Available
Research Site
Istanbul, 34098
TurkeySite Not Available
Research Site
Kayseri, 38039
TurkeySite Not Available
Research Site
Umraniye, 34760
TurkeySite Not Available
Research Site
Ankara, 06230
Turkey (Türkiye)Active - Recruiting
Research Site
Ankara 323786, 06230
Turkey (Türkiye)Site Not Available
Research Site
Istanbul, 34098
Turkey (Türkiye)Active - Recruiting
Research Site
Istanbul 745044, 34098
Turkey (Türkiye)Site Not Available
Research Site
Kayseri, 38039
Turkey (Türkiye)Active - Recruiting
Research Site
Kayseri 308464, 38039
Turkey (Türkiye)Site Not Available
Research Site
Umraniye, 34760
Turkey (Türkiye)Active - Recruiting
Research Site
Umraniye 738377, 34760
Turkey (Türkiye)Site Not Available
Research Site
Birmingham, B4 6NH
United KingdomActive - Recruiting
Research Site
Birmingham 2655603, B4 6NH
United KingdomSite Not Available
Research Site
Bristol, BS2 8BJ
United KingdomActive - Recruiting
Research Site
Bristol 2654675, BS2 8BJ
United KingdomSite Not Available
Research Site
Liverpool, L12 2AP
United KingdomActive - Recruiting
Research Site
Liverpool 2644210, L12 2AP
United KingdomSite Not Available
Research Site
London, WC1N 3JH
United KingdomActive - Recruiting
Research Site
London 2643743, NW1 2PG
United KingdomSite Not Available
Research Site
Manchester, M13 9WL
United KingdomActive - Recruiting
Research Site
Manchester 2643123, M13 9WL
United KingdomSite Not Available
Research Site
Southampton, SO16 6YD
United KingdomActive - Recruiting
Research Site
Southampton 2637487, SO16 6YD
United KingdomSite Not Available
Research Site
Phoenix, Arizona 85016
United StatesActive - Recruiting
Research Site
Phoenix 5308655, Arizona 5551752 85016
United StatesSite Not Available
Research Site
Los Angeles, California 90027
United StatesActive - Recruiting
Research Site
Los Angeles 5368361, California 5332921 90027
United StatesSite Not Available
Research Site
Washington, District of Columbia 20010
United StatesSite Not Available
Research Site
Washington D.C., District of Columbia 20010
United StatesActive - Recruiting
Research Site
Washington D.C. 4140963, District of Columbia 4138106 20010
United StatesSite Not Available
Research Site
Chicago, Illinois 60611
United StatesActive - Recruiting
Research Site
Chicago 4887398, Illinois 4896861 60637
United StatesSite Not Available
Research Site
New Orleans, Louisiana 70118
United StatesSite Not Available
Research Site
New Orleans 4335045, Louisiana 4331987 70118
United StatesSite Not Available
Research Site
Bethesda, Maryland 20889
United StatesSite Not Available
Research Site
Bethesda 4348599, Maryland 4361885 20889
United StatesSite Not Available
Research Site
Saint Paul, Minnesota 55125
United StatesActive - Recruiting
Research Site
Saint Paul 5045360, Minnesota 5037779 55125
United StatesSite Not Available
Research Site
Bronx, New York 10467
United StatesSite Not Available
Research Site
New Hyde Park, New York 11042
United StatesActive - Recruiting
Research Site
New York, New York 10032
United StatesActive - Recruiting
Research Site
The Bronx, New York 10467
United StatesActive - Recruiting
Research Site
Valhalla, New York 10595
United StatesActive - Recruiting
Research Site
New Hyde Park 5128514, New York 5128638 11042
United StatesSite Not Available
Research Site
New York 5128581, New York 5128638 10032
United StatesSite Not Available
Research Site
The Bronx 5110266, New York 5128638 10467
United StatesSite Not Available
Research Site
Valhalla 5142090, New York 5128638 10595
United StatesSite Not Available
Research Site
Durham, North Carolina 27710
United StatesActive - Recruiting
Research Site
Durham 4464368, North Carolina 4482348 27710
United StatesSite Not Available
Research Site
Cincinnati, Ohio 45229
United StatesActive - Recruiting
Research Site
Cleveland, Ohio 44109
United StatesActive - Recruiting
Research Site
Columbus, Ohio 43203
United StatesActive - Recruiting
Research Site
Cincinnati 4508722, Ohio 5165418 45229
United StatesSite Not Available
Research Site
Cleveland 5150529, Ohio 5165418 44109
United StatesSite Not Available
Research Site
Columbus 4509177, Ohio 5165418 43203
United StatesSite Not Available
Research Site
Portland, Oregon 97227
United StatesActive - Recruiting
Research Site
Portland 5746545, Oregon 5744337 97227
United StatesSite Not Available
Research Site
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
Research Site
Philadelphia 4560349, Pennsylvania 6254927 19104
United StatesSite Not Available
Research Site
Greenville, South Carolina 29605
United StatesSite Not Available
Research Site
Greenville 4580543, South Carolina 4597040 29605
United StatesSite Not Available
Research Site
El Paso, Texas 79902
United StatesActive - Recruiting
Research Site
Houston, Texas 77030
United StatesActive - Recruiting
Research Site
El Paso 5520993, Texas 4736286 79902
United StatesSite Not Available
Research Site
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available
Research Site
Salt Lake City, Utah 84108
United StatesActive - Recruiting
Research Site
Salt Lake City 5780993, Utah 5549030 84108
United StatesSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.