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Systemic Lupus ErythematosusPhase 2NCT07630714

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 study testing Anifrolumab + APFS in people with Systemic Lupus Erythematosus, run by AstraZeneca at 39 sites in 10 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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 more about this study

Who is it for?
Ages 5 to 17 years
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
Anifrolumab + APFS
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
39 sitesin 10 countries
Study dates
31 Aug 2026to 5 Sep 2031
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 16Show fewer
  • 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).

Trial locations and contacts

39 sites in 10 countries. Contact the study team or a site near you to ask about taking part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

39 sites in 10 countries

Israel5 sites, 5 recruiting

  • Research Site

    Haifa, 31096

    Not yet recruiting

  • Research Site

    Kfar Saba, 4428164

    Not yet recruiting

  • Research Site

    Petah Tikva, 4920235

    Not yet recruiting

  • Research Site

    Ramat Gan, 5265601

    Not yet recruiting

  • Research Site

    Tel Aviv, 64239

    Not yet recruiting

Other trials in Israel

Japan5 sites, 5 recruiting

  • Research Site

    Ginowan-shi, 901-2725

    Not yet recruiting

  • Research Site

    Kagoshima, 890-8520

    Not yet recruiting

  • Research Site

    Kanazawa, 920-8641

    Not yet recruiting

  • Research Site

    Niigata, 951-8520

    Not yet recruiting

  • Research Site

    Setagaya-ku, 157-8535

    Not yet recruiting

Other trials in Japan

Philippines5 sites, 5 recruiting

  • Research Site

    Cebu City, 6000

    Not yet recruiting

  • Research Site

    Dagupan, 2400

    Not yet recruiting

  • Research Site

    Davao City, 8000

    Not yet recruiting

  • Research Site

    Manila, 1000

    Not yet recruiting

  • Research Site

    Manila, 1008

    Not yet recruiting

Other trials in Philippines

Australia4 sites, 4 recruiting

  • Research Site

    Nedlands, 6009

    Not yet recruiting

  • Research Site

    Parkville, VIC 3052

    Not yet recruiting

  • Research Site

    Southport, 4215

    Not yet recruiting

  • Research Site

    Westmead, 2145

    Not yet recruiting

Other trials in Australia

Belgium4 sites, 4 recruiting

  • Research Site

    Brussels, 1200

    Not yet recruiting

  • Research Site

    Ghent, 9000

    Not yet recruiting

  • Research Site

    Leuven, 3000

    Not yet recruiting

  • Research Site

    Liège, 4000

    Not yet recruiting

Other trials in Belgium

Peru4 sites, 4 recruiting

  • Research Site

    Lima, 27

    Not yet recruiting

  • Research Site

    Lima, 33

    Not yet recruiting

  • Research Site

    Lima, LIMA 1

    Not yet recruiting

  • Research Site

    Lima, LIMA 31

    Not yet recruiting

Other trials in Peru

Portugal4 sites, 4 recruiting

  • Research Site

    Lisbon, 1169-045

    Not yet recruiting

  • Research Site

    Lisbon, 1649-035

    Not yet recruiting

  • Research Site

    Porto, 4050-519

    Not yet recruiting

  • Research Site

    Porto, 4200-319

    Not yet recruiting

Other trials in Portugal

Chile3 sites, 3 recruiting

  • Research Site

    Santiago, 7501126

    Not yet recruiting

  • Research Site

    Santiago, 7650568

    Not yet recruiting

  • Research Site

    Santiago, 8320000

    Not yet recruiting

Other trials in Chile

Netherlands3 sites, 3 recruiting

  • Research Site

    Amsterdam, 1105 AZ

    Not yet recruiting

  • Research Site

    Rotterdam, 3015 GD

    Not yet recruiting

  • Research Site

    Utrecht, 3584 CX

    Not yet recruiting

Other trials in Netherlands

Serbia2 sites, 2 recruiting

  • Research Site

    Belgrade, 11070

    Recruiting

  • Research Site

    Niš, 18000

    Recruiting

Other trials in Serbia

About this study

Official title: A Multicenter, Open-Label, Phase II Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous Anifrolumab in Pediatric Participants 5 to < 18 Years of Age With Systemic Lupus Erythematosus

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.

Being tested
Anifrolumab + APFS
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
Medical subject headings
Lupus Erythematosus, Systemic, Mycobacterium Infections, Nontuberculous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anifrolumab + APFSCombination product

    Also called MEDI-546, SAPHNELO™

    Anifrolumab will be administered as a SC injection using an APFS.

Study groups in NCT07630714
Study groupRoleWhat they receive
Cohort 1 (body weight > 40 kg)ExperimentalParticipants with body weight > 40 kg will receive anifrolumab as an injection in APFS.
Receives: Combination Product: Anifrolumab + APFS
Cohort 2 (body weight ≥ 15 to ≤ 40 kg)ExperimentalParticipants with body weight ≥ 15 to ≤ 40 kg will receive anifrolumab as an injection in APFS.
Receives: Combination Product: Anifrolumab + APFS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum observed serum (peak) concentration (Cmax)

    To characterize PK (Cmax) of anifrolumab in pediatric participants with SLE following SC administration.

    Measured: Cohort 1: From Day 1 to Day 8; Cohort 2: From Day 1 to Day 11

  2. Area under the serum concentration-time curve (AUC)

    To characterize PK (AUC) of anifrolumab in pediatric participants with SLE following SC administration.

    Measured: Cohort 1: From Day 1 to Day 8; Cohort 2: From Day 1 to Day 11

  3. Time to maximum plasma concentration (tmax)

    To characterize PK (tmax) of anifrolumab in pediatric participants with SLE following SC administration.

    Measured: Cohort 1: From Day 1 to Day 8; Cohort 2: From Day 1 to Day 11

  4. 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.

    Measured: Cohort 1: From Day 1 to Day 8; Cohort 2: From Day 1 to Day 11

  5. Trough drug concentration at steady state (Ctrough,ss)

    To characterize PK (Ctrough,ss) of anifrolumab in pediatric participants with SLE following SC administration.

    Measured: At Week 12

Secondary outcomes (6)

  1. Suppression of type I IFN 21-gene signature

    To characterize PD of anifrolumab in pediatric participants with SLE following SC administration.

    Measured: At Week 12 and 52

  2. Change from baseline in anti-double-stranded deoxyribonucleic acid (dsDNA) antibodies

    To characterize PD of anifrolumab in pediatric participants with SLE following SC administration.

    Measured: At Week 12 and 52

  3. Change from baseline in complement component 3 (C3) levels

    To characterize PD of anifrolumab in pediatric participants with SLE following SC administration.

    Measured: At Week 12 and 52

  4. Change from baseline in complement component 4 (C4) levels

    To characterize PD of anifrolumab in pediatric participants with SLE following SC administration.

    Measured: At Week 12 and 52

  5. Change from baseline in total hemolytic complement (CH50) levels

    To characterize PD of anifrolumab in pediatric participants with SLE following SC administration.

    Measured: At Week 12 and 52

  6. 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.

    Measured: From Day 1 to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2026
  2. Study start31 Aug 2026
  3. Primary completion2 Sep 2030 (estimated)
  4. Study completion5 Sep 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07630714
Sponsor's protocol ID
D3465C00008
Other IDs
2025-524578-41-00, EMA/PE/0000246211, 2025
Status last verified
Oct 2026
First submitted
2 Jun 2026
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Anifrolumab + APFS in people with Systemic Lupus Erythematosus, run by AstraZeneca at 39 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in Israel, Japan, Philippines, Australia, Belgium and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum observed serum (peak) concentration (Cmax) (time frame: Cohort 1: From Day 1 to Day 8; Cohort 2: From Day 1 to Day 11). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07630714.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.

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