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RECRUITING

NCT07691970

PHASE3

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

Sponsor: AstraZeneca

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

5 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

1072

Start Date

2026-08-31

Completion Date

2032-12-30

Last Updated

2026-10-02

Healthy Volunteers

Conditions

Systemic Sclerosis Cutaneous Lupus E Myopathies Systemic Lupus Erythematosus

Interventions

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

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.

Locations (128)

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Phoenix, Arizona, United States

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Los Angeles, California, United States

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San Francisco, California, United States

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Boca Raton, Florida, United States

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Fort Lauderdale, Florida, United States

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Chicago, Illinois, United States

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Ann Arbor, Michigan, United States

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Rochester, Minnesota, United States

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Omaha, Nebraska, United States

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New York, New York, United States

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Charlotte, North Carolina, United States

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Cleveland, Ohio, United States

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Portland, Oregon, United States

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Charleston, South Carolina, United States

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Roanoke, Virginia, United States

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Quilmes, Argentina

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San Miguel, Argentina

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Melbourne, Australia

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Mitcham, Australia

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Graz, Austria

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Graz, Austria

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Linz, Austria

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Vienna, Austria

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Ghent, Belgium

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Rio de Janeiro, Brazil

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Salvador, Brazil

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Santa Efigênia, Brazil

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São Paulo, Brazil

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Plovdiv, Bulgaria

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Sofia, Bulgaria

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Sofia, Bulgaria

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Québec, Canada

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Santiago, Chile

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Beijing, China

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Chongqing, China

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Guangzhou, China

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Jinan, China

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Lanzhou, China

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Shanghai, China

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Shenzhen, China

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Shenzhen, China

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Bogotá, Colombia

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Prague, Czechia

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Bordeaux, France

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Paris, France

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Paris, France

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Strasbourg, France

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Toulouse, France

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Dresden, Germany

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Essen, Germany

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Kiel, Germany

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Mainz, Germany

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Marburg, Germany

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Tübingen, Germany

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Chaïdári, Greece

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Hyderabad, India

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Kolkata, India

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New Delhi, India

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Pune, India

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Haifa, Israel

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Kfar Saba, Israel

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Brescia, Italy

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Cona, Italy

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Florence, Italy

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Milan, Italy

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Milan, Italy

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Roma, Italy

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Roma, Italy

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Kanazawa, Japan

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Maebashi, Japan

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Nagoya, Japan

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Sapporo, Japan

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Yokohama, Japan

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Guadalajara, Mexico

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Guadalajara, Mexico

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San Luis Potosí City, Mexico

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Rotterdam, Netherlands

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Iloilo City, Philippines

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Lipa City, Philippines

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Manila, Philippines

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Bydgoszcz, Poland

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Katowice, Poland

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Kielce, Poland

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Krakow, Poland

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Ossy, Poland

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Warsaw, Poland

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Braga, Portugal

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Lisbon, Portugal

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Porto, Portugal

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Bucharest, Romania

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Cluj-Napoca, Romania

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Iași, Romania

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Belgrade, Serbia

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Kragujevac, Serbia

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Košice, Slovakia

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Piešťany, Slovakia

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Johannesburg, South Africa

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Seoul, South Korea

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Seoul, South Korea

Research Site

Seoul, South Korea

And 28 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (128)