SAPHNELO Systemic Lupus Erythematosus Japan Post-Marketin... | NCT05141201

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 21, 2021Actual

Primary Completion Date

Mar 31, 2027Estimated

Completion Date

Mar 31, 2027Estimated

First Submitted Date

Nov 19, 2021

First Submission Date that Met QC Criteria

Nov 19, 2021

First Posted Date

Dec 2, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 16, 2026

Last Update Posted Date

Jun 17, 2026Actual

Description Module

Brief Summary

To collect information on and evaluate the long-term safety and effectiveness of Anifrolumab in patients with systemic lupus erythematosus in the real-world post-marketing setting.

Detailed Description

The objective of the Specific Use Result Study is to collect information on and evaluate the long-term safety and effectiveness of Anifrolumab in patients with systemic lupus erythematosus insufficiently responding to currently available treatment in the real-world post-marketing setting.

This investigation will be conducted to support the application for re-examination specified in Article 14-4 of the Pharmaceutical Affairs Law.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,620Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of ADRs	Incidence of ADRs related to Anifrolimab. Safety specification: Herpes zoster, serious infections, anaphylaxis, malignancy and reactivation of hepatitis B virus	from the baseline to 52 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with systemic lupus erythematosus insufficiently responding to currently available treatment -

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients with systemic lupus erythematosus insufficiently responding to currently available treatment

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Aichi			Japan
Research Site

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluatedas 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.

Types

Not provided

Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Access Criteria

When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level datain an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access.For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

URL

https://astrazenecagroup-dt.pharmacm.com/DT/Home

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases