A Phase 2 interventional study of Anifrolumab + APFS in Systemic Lupus Erythematosus, sponsored by AstraZeneca. Recruiting at 39 sites in 10 countries. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment
The purpose of this study is to characterize the pharmacokinetics (PK), pharmacodynamics (PD), and safety of subcutaneous (SC) anifrolumab in pediatric participants with moderate to severe systemic lupus erythematosus (SLE) while on background standard of care (SoC) therapy.
This is an open-label, multicenter study.
The study includes -
The study intervention (anifrolumab) will be administered subcutaneously using an accessorized pre-filled syringe (APFS) in 2 cohorts.
1,207 studies on the registry are indexed under Lupus Erythematosus, Systemic; 405 are open to participants now.
This study's planned enrollment of 24 is below the median of 52 across 876 interventional studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with body weight \> 40 kg will receive anifrolumab as an injection in APFS.
Combination Product: Anifrolumab + APFS
Participants with body weight ≥ 15 to ≤ 40 kg will receive anifrolumab as an injection in APFS.
Combination Product: Anifrolumab + APFS
Drug page: Anifrolumab
Anifrolumab will be administered as a SC injection using an APFS.
Also known as: MEDI-546, SAPHNELO™
Maximum observed serum (peak) concentration (Cmax)
To characterize PK (Cmax) of anifrolumab in pediatric participants with SLE following SC administration.
Time frame: Cohort 1: From Day 1 to Day 8; Cohort 2: From Day 1 to Day 11
Area under the serum concentration-time curve (AUC)
To characterize PK (AUC) of anifrolumab in pediatric participants with SLE following SC administration.
Time frame: Cohort 1: From Day 1 to Day 8; Cohort 2: From Day 1 to Day 11
Time to maximum plasma concentration (tmax)
To characterize PK (tmax) of anifrolumab in pediatric participants with SLE following SC administration.
Time frame: Cohort 1: From Day 1 to Day 8; Cohort 2: From Day 1 to Day 11
Apparent total body clearance of drug from plasma (CL/F)
To characterize PK (CL/F) of anifrolumab in pediatric participants with SLE following SC administration.
Time frame: Cohort 1: From Day 1 to Day 8; Cohort 2: From Day 1 to Day 11
Trough drug concentration at steady state (Ctrough,ss)
To characterize PK (Ctrough,ss) of anifrolumab in pediatric participants with SLE following SC administration.
Time frame: At Week 12
Suppression of type I IFN 21-gene signature
To characterize PD of anifrolumab in pediatric participants with SLE following SC administration.
Time frame: At Week 12 and 52
Change from baseline in anti-double-stranded deoxyribonucleic acid (dsDNA) antibodies
To characterize PD of anifrolumab in pediatric participants with SLE following SC administration.
Time frame: At Week 12 and 52
Change from baseline in complement component 3 (C3) levels
To characterize PD of anifrolumab in pediatric participants with SLE following SC administration.
Time frame: At Week 12 and 52
Change from baseline in complement component 4 (C4) levels
To characterize PD of anifrolumab in pediatric participants with SLE following SC administration.
Time frame: At Week 12 and 52
Change from baseline in total hemolytic complement (CH50) levels
To characterize PD of anifrolumab in pediatric participants with SLE following SC administration.
Time frame: At Week 12 and 52
Number and percentage of participants who develop anti drug antibody (ADA) against anifrolumab
To evaluate the immunogenicity of anifrolumab in pediatric participants with SLE following SC administration.
Time frame: From Day 1 to Week 52
Number with participants with adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs)
To evaluate the safety and tolerability of anifrolumab in pediatric participants with SLE following SC administration.
Time frame: Up to follow-up visit (12 weeks post last dose of study intervention) (approximately 64 weeks)
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Supporting information: Study protocol, Statistical analysis plan
Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Sep 2030, 48 months after the start.
Of 67 industry-sponsored phase 2 interventional studies under Lupus Erythematosus, Systemic, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 48. This study's planned 48 months is above that.
Counting every sponsor, half of 95 studies reached it within 36 months; a quarter within 27 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Anifrolumab
Lupus Erythematosus, Systemic →