RecruitingNCT07630714Updated Sep 22, 2026

A Study to Investigate Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous Anifrolumab in Pediatric Participants 5 to < 18 Years of Age With Systemic Lupus Erythematosus

A Phase 2 interventional study of Anifrolumab + APFS in Systemic Lupus Erythematosus, sponsored by AstraZeneca. Recruiting at 32 sites in 10 countries. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 24
Allocation: Non-randomized
Ages: 5 Years to 17 Years
Sex: All

Study summary

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.

Read the detailed description

This is an open-label, multicenter study.

The study includes -

Screening Period of up to 35 days
Period A (12-week, open-label treatment period)
Period B (a possible 12-week dosing regimen adjustment period, if required)
Treatment Extension Period (up-to-40-week, optional)
Period C (a 12-week safety follow-up period)

The study intervention (anifrolumab) will be administered subcutaneously using an accessorized pre-filled syringe (APFS) in 2 cohorts.

Conditions studied

Systemic Lupus Erythematosus

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Keywords

Human immunoglobulin (Ig) G1κ monoclonal antibody (mAb) directed against subunit 1 of the type I interferon (IFN) receptor
Accessorized pre-filled syringe
Pharmacokinetics
Pharmacodynamics

Who can participate

Ages eligible: 5 Years to 17 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Diagnosis of SLE.
Must be receiving at least one of the following SoC regimens for ≥ 4 weeks: oral glucocorticoids (≤1.0 mg/kg/day or ≤ 40 mg/day prednisone equivalent), antimalarials (hydroxychloroquine, chloroquine, or quinacrine), or a single permitted immunosuppressant (azathioprine, mycophenolate mofetil/mycophenolic acid, methotrexate, mizoribine, or tacrolimus) within specified dose limits.
Participant must have moderate to severe active SLE disease defined as Systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) ≥ 6 total points.
Body weight ≥ 15 kg.
Participants must agree to follow study specific contraception requirements as per local regulations.

Exclusion criteria

Exclusion Criteria:

Known diagnosis of an IFN mediated autoinflammatory interferonopathy.
History of, or current diagnosis of, clinically significant non-SLE related vasculitides.
Active, severe SLE-driven renal disease with significant proteinuria.
Active severe or unstable neuropsychiatric SLE including but not limited to aseptic meningitis; cerebral vasculitis; myelopathy; demyelination syndromes (ascending, transverse, acute inflammatory demyelinating polyradiculopathy); acute confusional state; impaired level of consciousness; psychosis; acute stroke or stroke syndrome; cranial neuropathy; status epilepticus; cerebellar ataxia; and mononeuritis multiplex.
In participants ≥ 11 years of age, a history or evidence of suicidal ideation (severity of 4 [active: method and intent, but no plan] or 5 [active: method, intent, and plan]) within the past 6 months; or any suicidal behavior within the past 12 months or recurrent suicidal behavior in the lifetime of the participant based on an assessment with the Columbia suicide severity rating scale (C-SSRS).
History of, or current diagnosis of, catastrophic antiphospholipid syndrome (APS).
History of recurrent or opportunistic infection requiring hospitalization and intravenous (IV) antibiotics.
Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection, or a positive result for human immunodeficiency virus (HIV) infection.
Active hepatitis B and C infection.
Any active or recent herpes zoster (HZ) infection that has not completely resolved within 12 weeks prior to study entry or that emerges between screening and Day 1.
Any history of severe or recurrent HZ, including non-cutaneous HZ, herpes encephalitis, ophthalmic herpes, or 2 or more prior HZ episodes.
Any cytomegalovirus (CMV) or Epstein Barr virus (EBV) infection that has not completely resolved.
History of cancer.
Prior receipt of anifrolumab.
Prior treatment with directly acting cytotoxic B-cell depleting therapeutics.
A known history of allergy or reaction to any component of the study intervention formulation or history of anaphylaxis to any human gamma globulin therapy, human proteins, or monoclonal antibodies (mAbs).

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Sequential assignment
Masking: None (open label)
Enrollment: 24 participants (estimated)

Study arms

Experimental
Cohort 1 (body weight > 40 kg)
Participants with body weight \> 40 kg will receive anifrolumab as an injection in APFS.
Combination Product: Anifrolumab + APFS
Experimental
Cohort 2 (body weight ≥ 15 to ≤ 40 kg)
Participants with body weight ≥ 15 to ≤ 40 kg will receive anifrolumab as an injection in APFS.
Combination Product: Anifrolumab + APFS

Interventions

Combination productAnifrolumab + APFS
Anifrolumab will be administered as a SC injection using an APFS.
Also known as: MEDI-546, SAPHNELO™

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Other outcomes

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)

Study locations

2 of 32 sites recruiting

Research Site
Parkville, VIC 3052, Australia
Not yet recruiting
Research Site
Westmead, 2145, Australia
Not yet recruiting
Research Site
Brussels, 1200, Belgium
Not yet recruiting
Research Site
Ghent, 9000, Belgium
Not yet recruiting
Research Site
Leuven, 3000, Belgium
Not yet recruiting
Research Site
Liège, 4000, Belgium
Not yet recruiting
Research Site
Santiago, 8320000, Chile
Not yet recruiting
Research Site
Haifa, 31096, Israel
Not yet recruiting
Research Site
Kfar Saba, 4428164, Israel
Not yet recruiting
Research Site
Petah Tikva, 4920235, Israel
Not yet recruiting
Research Site
Ramat Gan, 5265601, Israel
Not yet recruiting
Research Site
Ginowan-shi, 901-2725, Japan
Not yet recruiting
Research Site
Kagoshima, 890-8520, Japan
Not yet recruiting
Research Site
Kanazawa, 920-8641, Japan
Not yet recruiting
Research Site
Niigata, 951-8520, Japan
Not yet recruiting
Research Site
Amsterdam, 1105 AZ, Netherlands
Not yet recruiting
Research Site
Rotterdam, 3015 GD, Netherlands
Not yet recruiting
Research Site
Utrecht, 3584 CX, Netherlands
Not yet recruiting
Research Site
Lima, 27, Peru
Not yet recruiting
Research Site
Lima, 33, Peru
Not yet recruiting
Research Site
Lima, LIMA 1, Peru
Not yet recruiting
Research Site
Lima, LIMA 31, Peru
Not yet recruiting
Research Site
Cebu City, 6000, Philippines
Not yet recruiting
Research Site
Dagupan, 2400, Philippines
Not yet recruiting
Research Site
Manila, 1000, Philippines
Not yet recruiting
Research Site
Manila, 1008, Philippines
Not yet recruiting
Research Site
Lisbon, 1169-045, Portugal
Not yet recruiting
Research Site
Lisbon, 1649-035, Portugal
Not yet recruiting
Research Site
Porto, 4050-519, Portugal
Not yet recruiting
Research Site
Porto, 4200-319, Portugal
Not yet recruiting
Research Site
Belgrade, 11070, Serbia
Recruiting
Research Site
Niš, 18000, Serbia
Recruiting

References and documents

Individual participant data

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, Sap

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT07630714
Lead sponsor: AstraZeneca
Responsible party: Sponsor
First posted: Jun 5, 2026
Start date: Aug 31, 2026
Primary completion: Sep 2, 2030 (estimated)
Completion: Sep 5, 2031 (estimated)
Last update: Sep 22, 2026

Study contacts

AstraZeneca Clinical Study Information Center

Contact

information.center@astrazeneca.com

1-877-240-9479

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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