NCT07688980Not yet recruitingPhase 1
Study to Characterise Pharmacokinetics (PK), Pharmacodynamics (PD), and Safety of Anifrolumab Administered Subcutaneously (SC) or Intravenously (IV)
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
Source: ClinicalTrials.gov · Last updated 7 Jul 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 92 (estimated)
- First submitted
- 30 Jun 2026
- Start date
- Oct 2026
- Primary completion date
- Apr 2029
- Lead sponsor
- AstraZeneca
- Diseases
- Lupus (SLE)
- NCT number
- NCT07688980
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 92
- From Oct 2026 to the primary completion date, Apr 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any severe case of herpes zoster infection at any time prior to Week 0 (Day 1).
Other illness
- Active severe SLE-driven renal disease.
- At Screening, confirmed positive test for hepatitis B serology or positive test for hepatitis C antibody.
- Opportunistic infection requiring hospitalisation or IV antimicrobial treatment within 3 years of randomisation
- 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.
Lab values
- 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.
Other
- Active severe or unstable neuropsychiatric SLE.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.