NCT07431775Not yet recruiting
Saphnelo Use in Females of Child-bearing Potential
A Non-Interventional Descriptive Multi-Country Study of Saphnelo™ (Anifrolumab-fnia) Utilization in Females of Reproductive Potential
Source: ClinicalTrials.gov · Last updated 25 Feb 2026
Brief summary (registry, in English)
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by substantial clinical burden-including organ damage, increased morbidity, and mortality-that often presents in young adulthood and disproportionately affects female patients. SAPHNELO™ (anifrolumab-fnia), a fully human IgG1 κ monoclonal antibody, is a novel therapeutic option approved for add-on treatment of moderate-to-severe SLE in the United States (US) on 30 July 2021 and in the European Union on 14 February 2022. To fulfill US Food and Drug Administration (FDA) post-marketing requirements for the evaluation of anifrolumab safety in pregnancy, additional evidence is needed to better understand the real-world drug utilization of anifrolumab in female patients of reproductive potential.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 26000000 (estimated)
- First submitted
- 12 Jan 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 31 Mar 2032
- Lead sponsor
- AstraZeneca
- Diseases
- Lupus (SLE)
- NCT number
- NCT07431775
What you commit to
- Study type: Observational
- Planned participants: 26000000
- From 1 Oct 2026 to the primary completion date, 31 Mar 2032
- 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
- (Primary Objective 1a only) Evidence of prior anifrolumab use in all available data prior to the index date through 1 day prior to the index date
- Patients will be included in the secondary objective cohort if they satisfy the following inclusion and exclusion criteria:
- Evidence of prior anifrolumab use in all available data prior the index date through 1 day prior to the index date.
Who the study is looking for
- Observability (enrollment or activity) in the data source for at least one day during the patient identification period within that calendar year (set earliest qualifying date as "index date" for primary objectives)
- Female sex at index date
- Age ≥15 and ≤50 years at index date
- Receipt of anifrolumab therapy during the patient identification period (identify earliest record of anifrolumab in this period and set as "index date" for secondary objectives).
- Female sex at index date.
- Age ≥15 and ≤50 years at index date.
- ≥180 days of continuous observability (e.g., enrollment or activity) in the dataset prior to and including the index date.
- (For Secondary Objective 3 only) SLE diagnosis, defined as having at least one unique health care encounter record with an International Classification of Diseases, 10th Revision (ICD-10) code of M32\* (excluding M32.0: drug-induced SLE) within the 180-day baseline period prior to and including the index date.
Criteria the registry did not label
- Patients will be included in the primary objective cohort for a given calendar year interval, if they satisfy the following inclusion and exclusion criteria within that year:
Age in the registry: 15 years to 50 years · Sex: Female · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.