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Monoclonal Antibodies

Anifrolumab for Lupus (SLE 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at week 52

Awards & highlights

SLE 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.Check my eligibility

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.See study design

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.

SLE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with lupus according to the 2019 EULAR/ACR criteria.

SLE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at week 52

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

+5 more

Other outcome measures

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

Herpes zoster

Sinusitis

Cough

Headache

Back pain

Arthralgia

Nausea

Pneumonia

Angioedema

Hypoaesthesia

Cervical dysplasia

Acute coronary syndrome

Chilaiditi's syndrome

Hypersensitivity

Appendicitis

Diverticulitis

Gastroenteritis viral

Lip squamous cell carcinoma

Fall

Nephrolithiasis

Traumatic fracture

Blood creatinine increased

Osteonecrosis

Systemic lupus erythematosus

100%

80%

60%

40%

20%

Study treatment Arm

Anifrolumab 300 mg

Placebo

SLE 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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,278 Previous Clinical Trials

288,615,084 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there numerous sites across the United States conducting this clinical study?

"Currently, this investigation is being conducted at a total of 71 sites. These are spread out in various cities including Philadelphia, Los Angeles, and Toronto along with another 71 locations. Opting for the site closest to you could reduce your need for extensive travel during participation."

Answered by AI

What is the current number of participants being admitted to this clinical study?

"Yes, data on clinicaltrials.gov indicates that this research is actively seeking volunteers. The trial was initially shared on March 14th, 2024, with the most recent update made on April 26th, 2024. A total of 100 participants are sought from a network of 71 sites."

Answered by AI

Is there an age restriction for participation in this study?

"Eligible candidates for this study should range from 5 to 17 years old. There are a total of 27 investigations focusing on individuals under 18 and 146 targeting those over the age of 65."

Answered by AI

Are there any available positions for participants in this research study?

"Indeed, information from clinicaltrials.gov indicates that this investigation is presently seeking volunteers. The trial was initially registered on March 14th, 2024, and most recently revised on April 26th of the same year. Across a network of 71 sites, the study aims to enroll a total of 100 participants."

Answered by AI

What is the level of safety associated with Anifrolumab for individuals?

"According to Power's assessment, the safety rating for Anifrolumab is graded as 3 due to its Phase 3 trial status, indicating a foundation of efficacy data and extensive safety data accumulation."

Answered by AI

Which individuals are eligible to participate in this clinical trial?

"Participants should not display any signs or symptoms of active tuberculosis, nor show any history indicative of such conditions during medical evaluations. Recent contact with individuals having active TB necessitates evaluation by a TB specialist before starting"

Answered by AI

What are the primary goals and objectives of this medical study?

"The primary objective of this study is to assess the response rate based on British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) criteria by Day 29. Secondary endpoints include evaluating participants' responses according to Systemic Lupus Erythematosus Responder Index (SRI-4), which considers a significant reduction in SLE disease activity and organ involvement compared to baseline, as well as changes in complement components and CH50 levels through Week 52. Additionally, the study aims to analyze the percentage reduction from baseline in oral corticosteroid use over 52 weeks between pediatric patients receiving Anifrolumab"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "An Efficacy and Safety Study of Intravenous Anifrolumab to Treat Systemic Lupus Erythematosus in Pediatric Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05835310.

All > Systemic Lupus Erythematosus > Lupus