Pediatric Lupus

Clinical Trial 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
Trial Status Open to Enrollment
Start Date 10/31/2023
Location Randall Children's Hospital at Legacy Emanuel
Trial Type Pediatric Rheumatology
Specific Condition Lupus Erythematosus
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, randomized, pharmacokinetic period.
• Part B is a double-blind, placebo-controlled, randomized, 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 Eligibility Criteria:  
• Diagnosis of SLE for at least 3 months prior to signing consent
• At Screening, participant must have moderate to severe active SLE disease
• No signs or symptoms of active tuberculosis
 
IRB Number 10888
Notes https://clinicaltrials.gov/search?cond=Lupus%20Erythematosus,%20Systemic&term=D3461C00030&viewType=Card
Principal Investigator Daniel Kingsbury, MD
Contact Name Brenna Bogle
Contact Phone 503-413-3508
Contact Fax 503-413-3543
Contact E-Mail bbogle@lhs.org