Adults 18 to 70, any sex, with Active Systemic Lupus Erythematosus. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Exposure-adjusted Incidence Rates (EAIRs) of Adverse Events of Special Interest (AESIs)Primary· Up to a maximum of 1114 days
The event rate per 100 participant years was defined as the number of participants with an event divided by the sum of exposure time during the LTE study (including follow-up) in days for all participants in the analysis set multiplied by 365.25 days/year multiplied by 100. The exposure in a time period for each participant was calculated as end of period - start of period + 1. EAIRs of AESIs are presented as event rate per 100 participant years.
The following AESIs were pre-defined:
* Non-opportunistic serious infections
* Opportunistic infections
* Anaphylaxis
* Malignancy
* Herpes zoster
EAIRs of Serious Adverse Events (SAEs)Primary· Up to a maximum of 1114 days
EAIRs of SAEs are presented as event rate per 100 participant years.
An SAE was an AE occurring during any study phase that fulfils 1 or more of the following criteria:
* Results in death
* Is immediately life-threatening
* Requires in-patient hospitalisation or prolongation of existing hospitalisation
* Results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions
* Is a congenital abnormality or birth defect
* Is an important medical event that may jeopardise the participant or may require medical intervention to preven
Time frame: Day 1 up to until follow-up visit 2 (Week 164).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
NCT07431775 — Saphnelo Use in Females of Child-bearing Potential
· not yet recruiting
NCT07430306 — A Study to Evaluate the Treatment Outcomes of Subcutaneous Anifrolumab in Immunosuppressant-naïve and Biologic-naïve Sys
· Phase 3
· not yet recruiting
NCT07000110 — Anifrolumab Malignancy and Serious Infections Study
· recruiting
NCT06594068 — Prospective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users
· Phase 4
· recruiting
NCT07330245 — Achievement of LLDAS5 in Patients With Systemic Lupus Erythematosus Treated With Anifrolumab.
· recruiting
Other AstraZeneca trials
Trials by the same sponsor.
NCT06998095 — Tezepelumab (Tezspire) Regulatory Postmarketing Surveillance in Korea
· not yet recruiting
NCT07431775 — Saphnelo Use in Females of Child-bearing Potential
· not yet recruiting
NCT07516184 — Explore the Diagnostic Value of Bronchodilation Test With Portable Oscillometry in Asthma Diagnosis
· NA
· not yet recruiting
NCT07279935 — Osimertinib Combined With Chemotherapy in Patients Who Had Distant Recurrence After Adjuvant Osimertinib for EGFRm Resec
· Phase 4
· not yet recruiting
NCT07279948 — A Single-arm Observational Study to Characterize the Demographic, Clinical Features and Outcomes of a Brazilian Cohort o
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
Last refreshed: 13 January 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02794285.