Recruiting
Phase 3

Anifrolumab

Sponsor:

AstraZeneca

Code:

NCT07691970

Conditions

Systemic Sclerosis Cutaneous Lupus E Myopathies Systemic Lupus Erythematosus

Eligibility Criteria

Sex: All

Age: 5 - 70+

Healthy Volunteers: Not accepted

Interventions

Anifrolumab

Anifrolumab

Anifrolumab

Study Details

Brief 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.

Conditions

Systemic Sclerosis Cutaneous Lupus E Myopathies Systemic Lupus Erythematosus

Study ID

NCT07691970

Start date

Aug 31, 2026

Status verified date

Sep, 2026

Completion date

Dec 30, 2032

Anticipated

Primary completion date

Dec 30, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

1072 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Anifrolumab

Anifrolumab pre-filled syringe

Anifrolumab

Anifrolumab solution for injection in pre-filled pen

Anifrolumab

Anifrolumab concentrate for solution for infusion

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 and Locations

Central contacts

AstraZeneca Clinical Study Information Center

+1877-240-9479information.center@astrazeneca.com

Locations

Research Site

Recruiting

Los Angeles, California, United States, 90045

More Information

Sponsor

AstraZeneca

Last update posted

Oct 2, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-03. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-10-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.