Anifrolumab Trial for Systemic Lupus Erythematosus (SLE)

Anifrolumab Trial for Systemic Lupus Erythematosus (SLE)

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This study is now recruiting. Learn more about enrolling here.

Description
The purpose of this study is to find out if the study drug, Anifrolumab, is effective and safe for pediatric participants with moderate to severe active systemic lupus erythematosus (SLE) while on background standard of care therapy. Researchers will also be testing how the body processes a drug by measuring how quickly the drug is absorbed by the body, how quickly it is broken down by the body, and how long it remains in the body (pharmacokinetics). Subjects will be asked to come into the Rheumatology clinic for blood, hepatitis/HIV, urine, and pregnancy testing, physical exam, an electrocardiogram (ECG), questionnaire completion, medical record review, corticosteroid use, and administration of study drug. Anifrolumab is administered as an infusion every 4 weeks over the course of the study. 

Eligibility and criteria
IRB Number:
23-021254
Eligible age range:
5 years - 18 years
Clinical trial phase:
Phase III
Official title:
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

What to expect

The study will consist of 4 parts: Part A is for only 16 participants who will randomly receive the study drug or placebo and will have 6 visits over 4 weeks; Part B for 100 participants which may also include Part A participants who will randomly receive the study drug or placebo and will have 14 visits over 52 weeks; Part C for all participants who complete Part B and will receive the study drug for up to 52 weeks; Part C for 12 weeks of safety follow up after the last dose of study drug.

Related specialties
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