Find Systemic Lupus Erythematosus (SLE) Clinical Trials Near You
A Phase III, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety of IV Anifrolumab in Pediatric Participants 5 to < 18 Years of Age With Moderate to Severe Active Systemic Lupus Erythematosus While on Background Standard of Care Therapy
Status: Recruiting
Location: See all (97) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 3
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)
Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 17
Healthy Volunteers: f
View:
• Participant's parent/caregiver/legally authorized representative and participant (if required per local country regulation) capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. Informed assent is to be provided by the participant per local country regulation.
• Diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) criteria for at least 3 months prior to signing the 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 pregnancy test at screening and negative urine pregnancy test at randomization.
• Female participants of childbearing and male participants must adhere to the contraception methods.
Locations
United States
Arizona
Research Site
RECRUITING
Phoenix
California
Research Site
RECRUITING
Los Angeles
Washington, D.c.
Research Site
RECRUITING
Washington D.c.
Illinois
Research Site
RECRUITING
Chicago
Research Site
RECRUITING
Chicago
Louisiana
Research Site
NOT_YET_RECRUITING
New Orleans
Maryland
Research Site
WITHDRAWN
Bethesda
Minnesota
Research Site
RECRUITING
Saint Paul
North Carolina
Research Site
RECRUITING
Durham
New York
Research Site
RECRUITING
New Hyde Park
Research Site
RECRUITING
New York
Research Site
RECRUITING
The Bronx
Research Site
RECRUITING
Valhalla
Ohio
Research Site
RECRUITING
Cincinnati
Research Site
RECRUITING
Cleveland
Research Site
RECRUITING
Columbus
Oregon
Research Site
RECRUITING
Portland
Pennsylvania
Research Site
RECRUITING
Philadelphia
South Carolina
Research Site
WITHDRAWN
Greenville
Texas
Research Site
RECRUITING
El Paso
Research Site
RECRUITING
Houston
Utah
Research Site
RECRUITING
Salt Lake City
Other Locations
Argentina
Research Site
WITHDRAWN
Buenos Aires
Research Site
RECRUITING
Córdoba
Research Site
RECRUITING
Rosario
Research Site
NOT_YET_RECRUITING
San Miguel De Tucumán
Brazil
Research Site
RECRUITING
Porto Alegre
Research Site
RECRUITING
Ribeirão Preto
Research Site
RECRUITING
São Paulo
Research Site
RECRUITING
São Paulo
Canada
Research Site
NOT_YET_RECRUITING
Calgary
Research Site
RECRUITING
Toronto
Research Site
RECRUITING
Vancouver
China
Research Site
RECRUITING
Beijing
Research Site
WITHDRAWN
Beijing
Research Site
RECRUITING
Changchun
Research Site
RECRUITING
Changsha
Research Site
NOT_YET_RECRUITING
Nanjing
Research Site
RECRUITING
Shanghai
Research Site
RECRUITING
Suzhou
Research Site
RECRUITING
Wenzhou
Research Site
RECRUITING
Zhengzhou
Colombia
Research Site
RECRUITING
Barranquilla
Research Site
WITHDRAWN
Medellín
France
Research Site
RECRUITING
Bordeaux
Research Site
RECRUITING
Bron
Research Site
RECRUITING
Le Kremlin-bicêtre
Research Site
RECRUITING
Lille
Research Site
RECRUITING
Toulouse
Germany
Research Site
RECRUITING
Berlin
Research Site
RECRUITING
Freiburg Im Breisgau
Research Site
RECRUITING
Sankt Augustin
Italy
Research Site
RECRUITING
Genova
Research Site
RECRUITING
Milan
Research Site
NOT_YET_RECRUITING
Milan
Research Site
RECRUITING
Padova
Research Site
RECRUITING
Roma
Japan
Research Site
RECRUITING
Bunkyō City
Research Site
RECRUITING
Bunkyō City
Research Site
RECRUITING
Chiba
Research Site
RECRUITING
Fuchu-shi
Research Site
RECRUITING
Kawasaki-shi
Research Site
RECRUITING
Kobe
Research Site
RECRUITING
Obu-shi
Research Site
RECRUITING
Shinjuku-ku
Research Site
RECRUITING
Yokohama
Research Site
RECRUITING
Yokohama
Mexico
Research Site
NOT_YET_RECRUITING
Atizapán De Zaragoza
Research Site
RECRUITING
Guadalajara
Research Site
RECRUITING
Mérida
Research Site
RECRUITING
México
Research Site
RECRUITING
Monterrey
Poland
Research Site
RECRUITING
Lodź
Research Site
RECRUITING
Warsaw
Research Site
RECRUITING
Wroclaw
Portugal
Research Site
WITHDRAWN
Lisbon
Research Site
WITHDRAWN
Lisbon
Research Site
WITHDRAWN
Porto
South Africa
Research Site
WITHDRAWN
Cape Town
Spain
Research Site
RECRUITING
Esplugues De Llobregat
Research Site
RECRUITING
Madrid
Research Site
NOT_YET_RECRUITING
Madrid
Research Site
RECRUITING
Madrid
Research Site
RECRUITING
Málaga
Research Site
NOT_YET_RECRUITING
Santiago De Compostela
Research Site
RECRUITING
Valencia
Turkey
Research Site
RECRUITING
Ankara
Research Site
RECRUITING
Istanbul
Research Site
RECRUITING
Kayseri
Research Site
RECRUITING
Umraniye
United Kingdom
Research Site
RECRUITING
Birmingham
Research Site
RECRUITING
Bristol
Research Site
RECRUITING
Liverpool
Research Site
RECRUITING
London
Research Site
RECRUITING
London
Research Site
RECRUITING
Manchester
Research Site
RECRUITING
Southampton
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date:2024-03-14
Estimated Completion Date:2030-01-09
Participants
Target number of participants:100
Treatments
Experimental: Anifrolumab
Randomized participants will receive anifrolumab via intravenous (IV) infusion every 4 weeks
Placebo_comparator: Placebo
Randomized participants will receive matching placebo via IV infusion