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

Conditions

• Systemic Sclerosis Cutaneous Lupus E Myopathies Systemic Lupus Erythematosus

Eligibility Criteria

Sex

ALL

Age

5 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Anifrolumab — COMBINATION_PRODUCT
  Anifrolumab pre-filled syringe
• Anifrolumab — COMBINATION_PRODUCT
  Anifrolumab solution for injection in pre-filled pen
• Anifrolumab — DRUG
  Anifrolumab concentrate for solution for infusion

Study Details

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.

Key Dates

First listed

Jul 9, 2026

Start date

Sep 1, 2026

Status verified

Jun 2026

Primary completion

Dec 31, 2032

Completion

Dec 31, 2032

Study Design

Enrollment

1,072 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

SAEs and Non-Serious AEs [ Time Frame: From first dose administered and until 12 weeks after the last dose of Anifrolumab ]

Central Contacts

• AstraZeneca Clinical Study Information Center
  +1877-240-9479
  [email protected]

Locations (6)

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