An Efficacy and Safety Study of Intravenous Anifrolumab to Treat Systemic Lupus Erythematosus in Pediatric Participants
Start Date
3/14/2024
Completion Date
1/9/2030
Summary
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)
Detailed Description
This study aims to characterize the pharmacokinetics, pharmacodynamics, efficacy, and safety of anifrolumab solution for infusion compared with placebo solution for infusion in pediatric participants with severe active systemic lupus erythematosus who are on background standard of care therapy. The study duration for a participant will be approximately 116 weeks, which includes: * Screening period of up to 30 days. * Part A consists of a four-week, double-blind, placebo-controlled, randomised, pharmacokinetic period. * Part B is a double-blind, placebo-controlled, randomised, safety/efficacy period lasting 48 weeks (for rollover participants from Part A) or 52 weeks (for de novo participants). * Part C is a 52-week open-label extension period. * Part D is a safety follow-up period. One safety visit at 12 weeks post last dose.
Eligibility Criteria
Age Range: 5 years to 17 years
Interventions
Anifrolumab
Placebo
Conditions
Locations
Research Site
Phoenix, Arizona 85016
United States
Research Site
Los Angeles, California 90027
United States
Research Site
Washington D.C., District of Columbia 20010
United States
Research Site
Chicago, Illinois 60611
United States
Research Site
Chicago, Illinois 60637
United States
Research Site
New Orleans, Louisiana 70118
United States
Research Site
Bethesda, Maryland 20889
United States
Research Site
Saint Paul, Minnesota 55125
United States
Research Site
New Hyde Park, New York 11042
United States
Research Site
New York, New York 10032
United States
Research Site
The Bronx, New York 10467
United States
Research Site
Valhalla, New York 10595
United States
Research Site
Durham, North Carolina 27710
United States
Research Site
Cincinnati, Ohio 45229
United States
Research Site
Cleveland, Ohio 44109
United States
Research Site
Columbus, Ohio 43203
United States
Research Site
Portland, Oregon 97227
United States
Research Site
Philadelphia, Pennsylvania 19104
United States
Research Site
Greenville, South Carolina 29605
United States
Research Site
El Paso, Texas 79902
United States
Research Site
Houston, Texas 77030
United States
Research Site
Salt Lake City, Utah 84108
United States
Research Site
Buenos Aires, C1270
Argentina
Research Site
Córdoba, 5000
Argentina
Research Site
Rosario, S2000PBJ
Argentina
Research Site
San Miguel de Tucumán, T4000AXL
Argentina
Research Site
Belo Horizonte, 30130-100
Brazil
Research Site
Porto Alegre, 90035-903
Brazil
Research Site
Ribeirão Preto, 14048-900
Brazil
Research Site
São Paulo, 04024-002
Brazil
Research Site
São Paulo, 05403 000
Brazil
Research Site
Calgary, British Columbia T2N 4N1
Canada
Research Site
Vancouver, British Columbia V6H 3N1
Canada
Research Site
Toronto, Ontario M5G 1X8
Canada
Research Site
Beijing, 100020
China
Research Site
Beijing, 100032
China
Research Site
Beijing, 100730
China
Research Site
Changchun, 130021
China
Research Site
Changsha, 410007
China
Research Site
Nanjing, 210008
China
Research Site
Shanghai, 201102
China
Research Site
Suzhou, 215002
China
Research Site
Wenzhou, 325027
China
Research Site
Zhengzhou, 450018
China
Research Site
Barranquilla, 01800
Colombia
Research Site
Medellín, 050034
Colombia
Research Site
Bordeaux, 33076
France
Research Site
Bron, 69677
France
Research Site
Le Kremlin-Bicêtre, 94275
France
Research Site
Lille, 59037
France
Research Site
Toulouse, 31300
France
Research Site
Berlin, D-13353
Germany
Research Site
Freiburg im Breisgau, 79106
Germany
Research Site
Sankt Augustin, 53757
Germany
Research Site
Genova, 16148
Italy
Research Site
Milan, 20122
Italy
Research Site
Milan, 20122
Italy
Research Site
Padova, 35128
Italy
Research Site
Roma, 00165
Italy
Research Site
Bunkyō City, 113-8519
Japan
Research Site
Bunkyō City, 113-8603
Japan
Research Site
Chiba, 266-0007
Japan
Research Site
Fuchu-shi, 183-8561
Japan
Research Site
Kawasaki-shi, 216-8511
Japan
Research Site
Kobe, 650-0047
Japan
Research Site
Obu-shi, 474-8710
Japan
Research Site
Shinjuku-ku, 162-8666
Japan
Research Site
Yokohama, 232 8555
Japan
Research Site
Yokohama, 236-0004
Japan
Research Site
Atizapán de Zaragoza, 52937
Mexico
Research Site
Guadalajara, 44620
Mexico
Research Site
Mérida, 97070
Mexico
Research Site
México, 06720
Mexico
Research Site
Monterrey, 64460
Mexico
Research Site
Lodź, 91-738
Poland
Research Site
Warsaw, 02-637
Poland
Research Site
Wroclaw, 52-114
Poland
Research Site
Lisbon, 1169-045
Portugal
Research Site
Lisbon, 1649-035
Portugal
Research Site
Porto, 4200-319
Portugal
Research Site
Cape Town, 7700
South Africa
Research Site
Esplugues de Llobregat, 8950
Spain
Research Site
Madrid, 28009
Spain
Research Site
Madrid, 28034
Spain
Research Site
Madrid, 28046
Spain
Research Site
Málaga, 29011
Spain
Research Site
Santiago de Compostela, 15706
Spain
Research Site
Valencia, 46026
Spain
Research Site
Ankara, 06230
Turkey (Türkiye)
Research Site
Istanbul, 34098
Turkey (Türkiye)
Research Site
Kayseri, 38039
Turkey (Türkiye)
Research Site
Umraniye, 34760
Turkey (Türkiye)
Research Site
Birmingham, B4 6NH
United Kingdom
Research Site
Bristol, BS2 8BJ
United Kingdom
Research Site
Liverpool, L12 2AP
United Kingdom
Research Site
London, NW1 2PG
United Kingdom
Research Site
London, WC1N 3JH
United Kingdom
Research Site
Manchester, M13 9WL
United Kingdom
Research Site
Southampton, SO16 6YD
United Kingdom