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

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

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

- 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 6 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 pregnancy test at Screening.
- Female participants of childbearing and non-childbearing potential and male participants must adhere to the contraception methods.
- At screening, negative SARS-CoV-2 RT-PCR or rapid antigen test result and no known or suspected COVID-19 infection or exposure between screening and randomization visits.

Exclusion Criteria

- Known diagnosis of an IFN-mediated autoinflammatory interferonopathy.
- History of, or current diagnosis of, clinically significant non-SLE-related vasculitides.
- In participants aged 11 years and above: history or evidence of suicidal ideation.
- History of any non-SLE disease that has required treatment with oral or parenteral corticosteroids for more than a total of 2 weeks within the last 24 weeks prior to signing the ICF.
- Any positive result on Screening for human immunodeficiency virus.
- Active hepatitis B surface antigen OR hepatitis B core antibody (HBcAb), hepatitis C virus (HCV) antibody and detectable HCV ribonucleic acid (RNA) or any severe case of Herpes Zoster infection.
- Any clinical cytomegalovirus or Epstein-Barr virus infection that has not completely resolved within 12 weeks prior to signing the ICF.
- History of severe COVID-19 infection requiring hospitalization, intensive care unit care, or assisted ventilation or any prior COVID-19 infection with unresolved sequelae. Any mild/asymptomatic COVID-19 infection (laboratory confirmed or suspected based on clinical symptoms).
- Prior use of Anifrolumab.
- Prior treatment with directly acting cytotoxic B-cell depleting therapeutics (eg, rituximab) < 26 weeks prior to ICF signature.
- Blood transfusion or receipt of blood products except albumin within 4 weeks prior to signing the ICF.

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Arms	Assigned Interventions
Experimental: Anifrolumab Randomized participants will receive a single dose of Anifrolumab via IV infusion every 4 weeks	Biological/Vaccine: Anifrolumab Participants will receive a single dose of Anifrolumab via IV infusion. Other Name: (MEDI-546)
Placebo Comparator: Placebo Randomized participants will receive matching placebo via IV infusion	Drug: Placebo Participants will receive matching placebo via IV infusion

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]