Systemic Lupus ErythematosusPhase 1NCT07688980
Study to Characterise Pharmacokinetics (PK), Pharmacodynamics (PD), and Safety of Anifrolumab Administered Subcutaneously (SC) or Intravenously (IV)
A Phase 1 study testing Anifrolumab: SC formulation via AI, Anifrolumab: IV formulation and Anifrolumab: SC formulation via aPFS in people with Systemic Lupus Erythematosus, run by AstraZeneca.
Trial summary
The purpose of this study is to assess the PK, PD, and safety of anifrolumab as SC administration or IV infusion in adult participants with systemic lupus erythematosus (SLE). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Anifrolumab: SC formulation via AI, Anifrolumab: IV formulation and Anifrolumab: SC formulation via aPFS
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2026to 14 Jun 2030
- Phase
- Phase 1
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who have a diagnosis of adult SLE according to the European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) 2019 criteria for ≥ 24 weeks prior to signing the informed consent form (ICF).
- "Clinical" Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) ≥ 4 points at Screening.
- Antinuclear antibody (ANA)-positive at Screening.
- Must be on stable background standard therapy with oral corticosteroids (OCS), antimalarials, and/or immunosuppressants alone or in combination.
Who cannot join
- Active severe or unstable neuropsychiatric SLE.
- Active severe SLE-driven renal disease.
- Known history of primary immunodeficiency, splenectomy, or any underlying condition predisposing to infection, or a positive result for Human Immunodeficiency Virus (HIV) infection confirmed by central laboratory at Screening.
- At Screening, confirmed positive test for hepatitis B serology or positive test for hepatitis C antibody.
- Any severe case of herpes zoster infection at any time prior to Week 0 (Day 1).
- Opportunistic infection requiring hospitalisation or IV antimicrobial treatment within 3 years of randomisation
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- History of cancer, apart from:
- Squamous or basal cell carcinoma of the skin treated with documented curative success ≥ 3 months prior to Day 1.
- Cervical cancer in situ treated with apparent curative success ≥ 1 year prior to Day 1.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
About this study
Official title: A Multicentre, Randomised, Open-label, Phase I Study to Characterise the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab Administered Subcutaneously or Intravenously in Participants With Systemic Lupus Erythematosus
The purpose of this study is to assess the PK, PD, and safety of anifrolumab as SC administration or IV infusion in adult participants with systemic lupus erythematosus (SLE).
Read the detailed description
This is a multicentre, randomised, phase I open-label study.
The study will comprise of the following:
- Screening period: Up to 30 days
- Two treatment periods
- Part A: Randomised SC vs IV Treatment Period: 5 weeks
- Part B: Optional Extended Treatment Period: Up to 47 weeks
- Safety follow-up period: 12 weeks after the final dose
Part A will include all participants who will be randomised into SC anifrolumab via autoinjector (AI) or IV anifrolumab.
Part B is an optional extended treatment period where participants will receive SC anifrolumab via accessorised prefilled syringe (aPFS).
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Anifrolumab: SC formulation via AI, Anifrolumab: IV formulation, Anifrolumab: SC formulation via aPFS
- Keywords
- Monoclonal antibody, Pharmacokinetics, Pharmacodynamics, Safety, Systemic lupus erythematosus
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anifrolumab: SC formulation via AICombination product
Anifrolumab will be administered subcutaneously via an AI.
Anifrolumab: IV formulationCombination product
Anifrolumab will be administered intravenously.
Anifrolumab: SC formulation via aPFSCombination product
Anifrolumab will be administered subcutaneously via an aPFS.
| Study group | Role | What they receive |
|---|---|---|
| Part A: SC | Experimental | Participants will receive SC anifrolumab administered via AI. Receives: Combination Product: Anifrolumab: SC formulation via AI |
| Part A: IV | Experimental | Participants will receive IV anifrolumab infusion. Receives: Combination Product: Anifrolumab: IV formulation |
| Part B | Experimental | Participants will receive SC anifrolumab administered via aPFS. Receives: Combination Product: Anifrolumab: SC formulation via aPFS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anifrolumab serum concentrations through Week 4
To characterise the PK exposure of SC or IV anifrolumab.
Measured: Up to Week 4
Secondary outcomes (1)
Percentage change from baseline in Type I interferon (IFN) 21-gene expression PD marker
To characterise the PD of SC or IV anifrolumab.
Measured: Up to Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start30 Oct 2026 (estimated)
- Primary completion13 Apr 2029 (estimated)
- Study completion14 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07688980
- Sponsor's protocol ID
- D3466C00003
- Status last verified
- Jun 2026
- First submitted
- 30 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomised, Open-label, Phase I Study to Characterise the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab Administered Subcutaneously or Intravenously in Participants With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT07688980
- Acronym / sponsor ID
- D3466C00003
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Monoclonal antibody, Pharmacokinetics, Pharmacodynamics, Safety, Systemic lupus erythematosus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 13 Apr 2029 (estimated)
- Study completion
- 14 Jun 2030 (estimated)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the PK, PD, and safety of anifrolumab as SC administration or IV infusion in adult participants with systemic lupus erythematosus (SLE).
Detailed description
This is a multicentre, randomised, phase I open-label study.
The study will comprise of the following:
- Screening period: Up to 30 days
- Two treatment periods
- Part A: Randomised SC vs IV Treatment Period: 5 weeks
- Part B: Optional Extended Treatment Period: Up to 47 weeks
- Safety follow-up period: 12 weeks after the final dose
Part A will include all participants who will be randomised into SC anifrolumab via autoinjector (AI) or IV anifrolumab.
Part B is an optional extended treatment period where participants will receive SC anifrolumab via accessorised prefilled syringe (aPFS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A: SC | Experimental | Combination Product: Anifrolumab: SC formulation via AIParticipants will receive SC anifrolumab administered via AI. |
| Part A: IV | Experimental | Combination Product: Anifrolumab: IV formulationParticipants will receive IV anifrolumab infusion. |
| Part B | Experimental | Combination Product: Anifrolumab: SC formulation via aPFSParticipants will receive SC anifrolumab administered via aPFS. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants who have a diagnosis of adult SLE according to the European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) 2019 criteria for ≥ 24 weeks prior to signing the informed consent form (ICF).
- "Clinical" Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) ≥ 4 points at Screening.
- Antinuclear antibody (ANA)-positive at Screening.
- Must be on stable background standard therapy with oral corticosteroids (OCS), antimalarials, and/or immunosuppressants alone or in combination.
Key exclusion criteria (9 listed)
- Active severe or unstable neuropsychiatric SLE.
- Active severe SLE-driven renal disease.
- Known history of primary immunodeficiency, splenectomy, or any underlying condition predisposing to infection, or a positive result for Human Immunodeficiency Virus (HIV) infection confirmed by central laboratory at Screening.
- At Screening, confirmed positive test for hepatitis B serology or positive test for hepatitis C antibody.
- Any severe case of herpes zoster infection at any time prior to Week 0 (Day 1).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anifrolumab: SC formulation via AIAnifrolumab will be administered subcutaneously via an AI. | Combination product | Part A: SC |
| Anifrolumab: IV formulationAnifrolumab will be administered intravenously. | Combination product | Part A: IV |
| Anifrolumab: SC formulation via aPFSAnifrolumab will be administered subcutaneously via an aPFS. | Combination product | Part B |
Primary outcome
Anifrolumab serum concentrations through Week 4
Time frame: Up to Week 4
To characterise the PK exposure of SC or IV anifrolumab.
1 secondary outcome
Percentage change from baseline in Type I interferon (IFN) 21-gene expression PD marker
Time frame: Up to Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Anifrolumab: SC formulation via AI, Anifrolumab: IV formulation and Anifrolumab: SC formulation via aPFS in people with Systemic Lupus Erythematosus, run by AstraZeneca.
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 4 inclusion and 9 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: opening soon, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Anifrolumab serum concentrations through Week 4 (time frame: Up to Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jul 2026.