Suspended

Saphnelo for Systemic Lupus Erythematosus

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Study Aim

This study observes the occurrence of adverse reactions in people with systemic lupus erythematosus who are taking Saphnelo, focusing on safety concerns like infections and allergic reactions.

What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Autoimmune Diseases+2

+ Connective Tissue Diseases

+ Immune System Diseases

1 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: December 2021
See protocol details

Summary

Principal SponsorAstraZeneca
Last updated: March 20, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 21, 2021

Actual date on which the first participant was enrolled.

This study aims to gather information about the long-term safety and effectiveness of a medicine called Anifrolumab in patients with systemic lupus erythematosus (SLE), a condition where the immune system attacks healthy tissue. The study focuses on patients who do not respond well to existing treatments. This is important because it can help determine if Anifrolumab is a safe and effective option for these patients in real-life settings, potentially providing a new avenue for managing their condition. Participants in the study will receive Anifrolumab through an intravenous infusion, which means the medicine will be delivered directly into their bloodstream. The study will monitor the occurrence of adverse drug reactions (ADRs), which are unwanted effects from the medication. Specifically, it looks at the likelihood of issues such as herpes zoster, serious infections, allergic reactions, cancer, and hepatitis B virus reactivation. Understanding these risks is crucial to ensure the treatment's safety for long-term use.

Official TitleSaphnelo for Intravenous Infusion 300 mg Specific Use Result Study All Patient Investigation in Patients With Systemic Lupus Erythematosus
NCT05141201
Principal SponsorAstraZeneca
Last updated: March 20, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1620 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Autoimmune DiseasesConnective Tissue DiseasesImmune System DiseasesLupus Erythematosus, SystemicSkin and Connective Tissue Diseases

Criteria

1 inclusion criteria required to participate
patients with systemic lupus erythematosus insufficiently responding to currently available treatment

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 47 locations

Suspended

Research Site

Aichi, JapanOpen Research Site in Google Maps
Suspended

Research Site

Akita, Japan
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Research Site

Aomori, Japan
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Research Site

Chiba, Japan
Suspended47 Study Centers