Phase
Condition
Cutaneous Lupus Erythematosus
Lupus
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 6 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 pregnancy test atScreening.
Female participants of childbearing and non-childbearing potential and maleparticipants must adhere to the contraception methods.
At screening, negative SARS-CoV-2 RT-PCR or rapid antigen test result and no knownor suspected COVID-19 infection or exposure between screening and randomizationvisits.
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 severe case ofHerpes 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
Córdoba, 5000
ArgentinaSite Not Available
Research Site
Rosario, S2000PBJ
ArgentinaSite Not Available
Research Site
Botucatu, 18610-070
BrazilActive - Recruiting
Research Site
Curitiba, 80030-110
BrazilActive - Recruiting
Research Site
Porto Alegre, 90035-903
BrazilActive - Recruiting
Research Site
Ribeirão Preto, 14048-900
BrazilActive - Recruiting
Research Site
Sao Paulo, 04024-002
BrazilActive - Recruiting
Research Site
São Paulo, 04037-002
BrazilSite Not Available
Research Site
Vancouver, British Columbia V6H 3N1
CanadaActive - Recruiting
Research Site
Toronto, Ontario M5G 1X8
CanadaActive - Recruiting
Research Site
Beijing, 100020
ChinaSite Not Available
Research Site
Changchun, 130021
ChinaActive - Recruiting
Research Site
Changsha, 410007
ChinaActive - Recruiting
Research Site
Shanghai, 201102
ChinaActive - Recruiting
Research Site
Suzhou, 215002
ChinaActive - Recruiting
Research Site
Wenzhou, 325027
ChinaActive - Recruiting
Research Site
Zhengzhou, 450018
ChinaActive - Recruiting
Research Site
Barranquilla, 01800
ColombiaSite Not Available
Research Site
Medellin, 050034
ColombiaSite Not Available
Research Site
Bordeaux, 33076
FranceActive - Recruiting
Research Site
Bordeaux Cedex, 33076
FranceSite Not Available
Research Site
Bron, 69677
FranceActive - Recruiting
Research Site
LILLE Cedex, 59037
FranceActive - Recruiting
Research Site
Le Kremlin Bicetre, 94275
FranceSite Not Available
Research Site
Le Kremlin-Bicêtre, 94275
FranceActive - Recruiting
Research Site
Toulouse, 31300
FranceActive - Recruiting
Research Site
Berlin, D-13353
GermanyActive - Recruiting
Research Site
Freiburg, 79106
GermanyActive - Recruiting
Research Site
Sankt Augustin, 53757
GermanyActive - Recruiting
Research Site
Genova, 16148
ItalyActive - Recruiting
Research Site
Milano, 20122
ItalyActive - Recruiting
Research Site
Padova, 35128
ItalySite Not Available
Research Site
Roma, 00165
ItalyActive - Recruiting
Research Site
Bunkyo-ku, 113-8519
JapanActive - Recruiting
Research Site
Chiba, 266-0007
JapanActive - Recruiting
Research Site
Fuchu-shi, 183-8561
JapanActive - Recruiting
Research Site
Kawasaki-shi, 216-8511
JapanActive - Recruiting
Research Site
Kobe-shi, 650-0047
JapanActive - Recruiting
Research Site
Obu-shi, 474-8710
JapanActive - Recruiting
Research Site
Shinjuku-ku, 162-8666
JapanActive - Recruiting
Research Site
Yokohama-shi, 236-0004
JapanActive - Recruiting
Research Site
Guadalajara, 44620
MexicoSite Not Available
Research Site
Merida, 97070
MexicoActive - Recruiting
Research Site
Mexico, 06720
MexicoSite Not Available
Research Site
Monterrey, 64460
MexicoSite Not Available
Research Site
Toluca, 50170
MexicoSite Not Available
Research Site
Lodź, 91-738
PolandActive - Recruiting
Research Site
Warszawa, 02-637
PolandActive - Recruiting
Research Site
Wroclaw, 52-114
PolandActive - Recruiting
Research Site
Lisboa, 1649-035
PortugalSuspended
Research Site
Porto, 4200-319
PortugalSuspended
Research Site
Cape Town, 7700
South AfricaSite Not Available
Research Site
Esplugues de Llobregat, 8950
SpainActive - Recruiting
Research Site
Madrid, 28009
SpainActive - Recruiting
Research Site
Málaga, 29011
SpainActive - Recruiting
Research Site
Valencia, 46026
SpainActive - Recruiting
Research Site
Ankara, 06230
TurkeyActive - Recruiting
Research Site
Istanbul, 34098
TurkeyActive - Recruiting
Research Site
Kayseri, 38039
TurkeyActive - Recruiting
Research Site
Umraniye, 34760
TurkeyActive - Recruiting
Research Site
Birmingham, B4 6NH
United KingdomSite Not Available
Research Site
Bristol, BS2 8BJ
United KingdomSite Not Available
Research Site
Liverpool, L12 2AP
United KingdomActive - Recruiting
Research Site
London, WC1N 3JH
United KingdomActive - Recruiting
Research Site
Manchester, M13 9WL
United KingdomSite Not Available
Research Site
Southampton, SO16 6YD
United KingdomActive - Recruiting
Research Site
Phoenix, Arizona 85016
United StatesActive - Recruiting
Research Site
Los Angeles, California 90027
United StatesActive - Recruiting
Research Site
Washington, District of Columbia 20010
United StatesSite Not Available
Research Site
Chicago, Illinois 60637
United StatesActive - Recruiting
Research Site
Bethesda, Maryland 20889
United StatesSite Not Available
Research Site
Saint Paul, Minnesota 55125
United StatesActive - Recruiting
Research Site
Bronx, New York 10467
United StatesActive - Recruiting
Research Site
New Hyde Park, New York 11042
United StatesActive - Recruiting
Research Site
New York, New York 10032
United StatesActive - Recruiting
Research Site
Valhalla, New York 10595
United StatesActive - Recruiting
Research Site
Durham, North Carolina 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 StatesSite Not Available
Research Site
Portland, Oregon 97227
United StatesActive - Recruiting
Research Site
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
Research Site
Greenville, South Carolina 29605
United StatesSite Not Available
Research Site
El Paso, Texas 79902
United StatesActive - Recruiting
Research Site
Houston, Texas 77030
United StatesActive - Recruiting
Research Site
Salt Lake City, Utah 84108
United StatesActive - Recruiting
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