An Efficacy and Safety Study of Intravenous Anifrolumab to Treat Systemic Lupus Erythematosus in Pediatric Participants - BLOSSOM

Study identifier:D3461C00030

ClinicalTrials.gov identifier:NCT05835310

EudraCT identifier:N/A

CTIS identifier:2022-502289-25-00

Recruiting

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 (SLE) While on Background Standard of Care Therapy

Medical condition

Systemic Lupus Erythematosus

Phase

Phase 3

Healthy volunteers

No

Study drug

Placebo

Sex

All

Estimated Enrollment

100

Study type

Interventional

Age

5 Years - 17 Years

Date

Study Start Date: 14 Mar 2024
Estimated Primary Completion Date: 25 Jul 2029
Estimated Study Completion Date: 21 May 2030

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Oct 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria