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Tests treatment safety and results for Systemic Lupus Erythematosus
Official title An Efficacy and Safety Study of Intravenous Anifrolumab to Treat Systemic Lupus Erythematosus in Pediatric Participants
ClinicalTrials.gov ID: NCT05835310
What this study is testing
What is Anifrolumab?
Anifrolumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for systemic lupus erythematosus.
Also referred to as (MEDI-546).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), Efficacy, and Safety of Anifrolumab in Children with Moderate to Severe Active Systemic Lupus Erythematosus (SLE)
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 17
You may be able to join if
- Participant's parent/caregiver/legally authorized representative and participant (if required per local country regulation) capable of giving signed...
- Diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) criteria for at least 3 months...
- At Screening, participant must have moderate to severe active SLE disease, as adjudicated by the Central Adjudication Committee, defined as: (a)...
- Participant should meet all of following tuberculosis (TB) criteria: A. No signs or symptoms of active TB B. No medical history or past physical...
- Female participants of childbearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy test at...
You likely can't join if
- 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...
- 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)...
See the full eligibility 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...
- Diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) criteria for at least 3 months prior to signing the ICF.
- At Screening, participant must have moderate to severe active SLE disease, as adjudicated by the Central Adjudication Committee, defined as: (a) SLEDAI-2K activity of: (i) ≥ 6 points with at least 4 points (≥ 4 points)...
- 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...
- Female participants of childbearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy test at randomization.
- Female participants of childbearing and male participants must adhere to the contraception methods.
- 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 active or recent 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Los Angeles, California, United States
- Washington D.C., District of Columbia, United States
- Chicago, Illinois, United States
- New Orleans, Louisiana, United States
- Bethesda, Maryland, United States
- Saint Paul, Minnesota, United States
- New Hyde Park, New York, United States
- New York, New York, United States
- The Bronx, New York, United States
- Valhalla, New York, United States
- Durham, North Carolina, United States
- Cincinnati, Ohio, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Greenville, South Carolina, United States
- El Paso, Texas, United States
- Houston, Texas, United States
+ 68 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 5 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Los Angeles, California, United States; Washington D.C., District of Columbia, United States; Chicago, Illinois, United States; New Orleans, Louisiana, United States; Bethesda, Maryland, United States and 82 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.