Rollover Study for Participants Who Have Completed a Previous Clinical Study With Anifrolumab (Saphnelo) and Clinically Benefited From Continued Treatment (ROSY-S)

ROSY-S: Rollover Study for Participants Who Have Completed a Previous Study With Anifrolumab (Saphnelo) and Are Assessed by the Investigator to Clinically Benefit From Continued Treatment

The purpose of this study is to provide continued access to anifrolumab to eligible participants who are continuing to derive clinical benefit from treatment at the end of a parent clinical study, as assessed by the Investigator, while monitoring safety and tolerability.

Study details include:

• Participants can transition in ROSY-S once they complete their participation in the parent study and should have received at least one dose of anifrolumab in the parent study. Participants with a treatment gap from parent studies and/or who are on compassionate use are eligible to rollover to ROSY-S study.
• The earliest that the Enrolment Visit may occur is at the time of the last visit of the parent study (ie, completion of the parent study's final safety follow-up visit). All required assessments from the safety follow-up visit of the parent study must be completed before the Enrolment Visit of ROSY-S study.
• The participants will continue to receive anifrolumab the same way they received it in the parent trial
• A participant is considered to have completed the study when they meet one of the discontinuation criteria.
• Safety will be monitored throughout the study. Both serious and nonserious AEs will be collected up to 12 weeks after the last dose of anifrolumab and will be reported as part of the primary safety endpoint.

Study Overview

• Status: Not yet recruiting
• Conditions: Systemic Sclerosis Cutaneous Lupus E Myopathies Systemic Lupus Erythematosus
• Intervention / Treatment: Combination product: Anifrolumab; Combination product: Anifrolumab; Drug: Anifrolumab

• Study Type: Interventional
• Enrollment (Estimated): 1072
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: +1877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• Austria
  • Graz, Austria, 8036
    • Research Site
  • Graz, Austria, 8010
    • Research Site
• Belgium
  • Ghent, Belgium, 9000
    • Research Site
• Brazil
  • Salvador, Brazil, 40150-150
    • Research Site
• Bulgaria
  • Sofia, Bulgaria, 1618
    • Research Site
• France
  • Bordeaux, France, 33076
    • Research Site
  • Strasbourg, France, 67200
    • Research Site
  • Toulouse, France, 31300
    • Research Site
• Greece
  • Chaïdári, Greece, 124 62
    • Research Site
• India
  • Kolkata, India, 700020
    • Research Site
• Israel
  • Haifa, Israel, 31048
    • Research Site
• Italy
  • Milan, Italy, 20122
    • Research Site
• Japan
  • Sapporo, Japan, 060-8648
    • Research Site
• Philippines
  • Iloilo City, Philippines, 5000
    • Research Site
  • Lipa City, Philippines, 4217
    • Research Site
• Poland
  • Bydgoszcz, Poland, 85-168
    • Research Site
  • Kielce, Poland, 25-316
    • Research Site
  • Krakow, Poland, 30-040
    • Research Site
• Romania
  • Iași, Romania, 700661
    • Research Site
• Serbia
  • Kragujevac, Serbia, 34000
    • Research Site
• Slovakia
  • Piešťany, Slovakia, 92101
    • Research Site
• South Korea
  • Seoul, South Korea, 6591
    • Research Site
• Spain
  • Barcelona, Spain, 8041
    • Research Site
  • Granada, Spain, 18014
    • Research Site
  • Madrid, Spain, 28034
    • Research Site
  • Madrid, Spain, 28041
    • Research Site
  • Valencia, Spain, 46014
    • Research Site
• Taiwan
  • Kaohsiung City, Taiwan, 83301
    • Research Site
  • Taichung, Taiwan, 404327
    • Research Site
• Thailand
  • Bangkok, Thailand, 10700
    • Research Site
  • Khon Kaen, Thailand, 40002
    • Research Site
• Turkey (Türkiye)
  • Fatih-Istanbul, Turkey (Türkiye), 34098
    • Research Site
• United Kingdom
  • London, United Kingdom, SE5 9RS
    • Research Site
  • Newcastle upon Tyne, United Kingdom, NE7 7DN
    • Research Site
  • Sheffield, United Kingdom, S10 2JF
    • Research Site
• United States
  • California
    • Los Angeles, California, United States, 90045
      • Research Site
  • Florida
    • Fort Lauderdale, Florida, United States, 33309
      • Research Site
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Research Site
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Research Site
  • New York
    • New York, New York, United States, 10029
      • Research Site
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants are eligible to be included in the study only if all of the following criteria apply:

  1 Participants must have completed the entirety of the parent study and should have received at least one dose of anifrolumab in the parent study.

• In the opinion of the Investigator, the potential benefit to the participant of continuing anifrolumab at the end of the parent study outweighs the risk.
• Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Participants should continue following the contraception requirements as per Appendix B from study enrolment up to 16 weeks after the last dose of study treatment.
• Capable of giving signed informed consent described in Appendix A which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
• Capable of adhering to the treatment plan related to this ROSY-S study.

Exclusion Criteria:

• Participant develops hypersensitivity to any of the components of anifrolumab.
• Female participant who is breastfeeding, pregnant, or intends to become pregnant during participation in this study.
• Currently participating in any investigational study or participated in an investigational study within 30 days prior to enrolment or within 5 half-lives of the investigational medicinal product (other than the parent study for anifrolumab) whichever is longer.
• Ongoing, unresolved AE requiring interruption of treatment at the end of the prior parent study (ie, when the parent study is either completed or closed) that in the Investigator's opinion would prevent restarting anifrolumab.
• Currently receiving or have received prohibited medication(s) as specified in parent protocols prior to signing ICF.
• Participants who are planning to use live/live-attenuated vaccines.
• Participants who are planning to use any other therapies, including B-cell therapies, that in the opinion of the Investigator could jeopardize or would compromise the participant's ability to participate in the program as determined by the Investigator.
• Participants with any medical condition (such as cancer or viral infections [hepatitis]) or psychiatric condition that, in the opinion of the Investigator, could jeopardise or would compromise the participant's ability to participate in this study as determined by the Investigator based on protocol required assessments.
• Participants who discontinued the parent study prior to completion of all study visits.
• Local access to approved and commercially available (reimbursed) drug for the defined indication as permitted by local/country regulation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anifrolumab; This is a single arm open-label study with the primary objective of providing continued access to anifrolumab to eligible participants who are continuing to derive clinical benefit from treatment and assessing long-term safety and tolerability of anifrolumab until participant meets one of the study discontinuation criteria.	Combination product: Anifrolumab; Anifrolumab pre-filled syringe; Combination product: Anifrolumab; Anifrolumab solution for injection in pre-filled pen; Drug: Anifrolumab; Anifrolumab concentrate for solution for infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SAEs and Non-Serious AEs	Safety will be evaluated by monitoring and assessing SAEs and Non-Serious AEs as reported throughout the study and until 12 weeks after the last dose of anifrolumab	From first dose administered and until 12 weeks after the last dose of Anifrolumab

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2032
• Study Completion (Estimated): December 31, 2032

Study Registration Dates

• First Submitted: June 23, 2026
• First Submitted That Met QC Criteria: July 7, 2026
• First Posted (Actual): July 9, 2026

Study Record Updates

• Last Update Posted (Actual): July 9, 2026
• Last Update Submitted That Met QC Criteria: July 7, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: anifrolumab
• Other Study ID Numbers: D346BC00004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment. "Yes" indicates that AstraZeneca is accepting requests for IPD, but this does not mean all requests will be shared.
• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability commitments in line with EFPIA/PhRMA Data Sharing Principles. For details of timelines, refer to AstraZeneca's disclosure commitment.
• IPD Sharing Access Criteria: When a request has been approved, AstraZeneca will provide access to anonymized individual patient-level data via a secure research environment (Vivli). A signed Data Usage Agreement must be in place before accessing the data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No