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Monoclonal Antibodies

Anifrolumab for Lupus (BLOSSOM Trial)

Phase 3
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) criteria.
Be younger than 18 years old
Must not have
Prior use of Anifrolumab.
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 52
Awards & highlights
Pivotal Trial

Summary

This trial aims to understand how well and how safe Anifrolumab works in children with moderate to severe active Systemic Lupus Erythematosus (SLE).

Who is the study for?
This trial is for children with moderate to severe active Systemic Lupus Erythematosus (SLE). Participants need consent from a parent or guardian, must meet specific SLE criteria, have no signs of active tuberculosis (TB), and girls able to have babies must not be pregnant and agree to use birth control. A negative COVID-19 test is also required.
What is being tested?
The study tests the effectiveness and safety of Anifrolumab given through an IV compared to a placebo in treating pediatric SLE. It will assess how the drug moves through and affects the body, as well as its ability to improve symptoms.
What are the potential side effects?
While specific side effects are not listed here, Anifrolumab may cause reactions at the infusion site, increase infection risk, trigger immune system responses or cause other common medication-related side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with lupus according to the 2019 EULAR/ACR criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have previously been treated with Anifrolumab.
Select...
I have active hepatitis B, hepatitis C, or a severe case of Herpes Zoster.
Select...
I have had a severe COVID-19 infection or still have health issues from it.
Select...
I have been diagnosed with a genetic form of lupus.
Select...
I have or had a significant blood vessel inflammation not related to lupus.
Select...
I have used steroids for more than 2 weeks in the last 6 months for a condition other than lupus.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Part A - Area under the serum concentration curve (AUC)
Part A - Area under the serum concentration-time curve at steady-state (AUCss)
Part A - Average serum concentration at steady-state (Css, avg)
+4 more
Secondary study objectives
Number of participants who are Pediatric Rheumatology International Trials Organization/American College of Rheumatology (PRINTO/ACR) childhood-onset systemic lupus erythematosus (cSLE) responders (yes/no)
Part - B Change from baseline through Week 52 in Anifrolumab serum concentration
Part - B Change from baseline through Week 52 in anti-dsDNA antibodies
+6 more
Other study objectives
All parts - Number of participants reporting suicidal ideation and/or suicidal behavior as per Columbia Suicide Severity Rating Scale (C-SSRS)
All parts - Number of participants with adverse events

Side effects data

From 2018 Phase 3 trial • 373 Patients • NCT02446899
23%
Upper respiratory tract infection
16%
Nasopharyngitis
14%
Infusion related reaction
13%
Bronchitis
12%
Urinary tract infection
7%
Herpes zoster
7%
Sinusitis
6%
Cough
6%
Headache
6%
Back pain
6%
Arthralgia
4%
Nausea
2%
Pneumonia
1%
Lip squamous cell carcinoma
1%
Cervical dysplasia
1%
Angioedema
1%
Hypoaesthesia
1%
Acute coronary syndrome
1%
Chilaiditi's syndrome
1%
Hypersensitivity
1%
Appendicitis
1%
Diverticulitis
1%
Gastroenteritis viral
1%
Fall
1%
Nephrolithiasis
1%
Traumatic fracture
1%
Blood creatinine increased
1%
Osteonecrosis
1%
Systemic lupus erythematosus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Anifrolumab 300 mg
Placebo

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AnifrolumabExperimental Treatment1 Intervention
Randomized participants will receive a single dose of Anifrolumab via IV infusion every 4 weeks
Group II: PlaceboPlacebo Group1 Intervention
Randomized participants will receive matching placebo via IV infusion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Anifrolumab
2015
Completed Phase 3
~1990

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,397 Previous Clinical Trials
289,121,603 Total Patients Enrolled
~67 spots leftby Jul 2029
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
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