Anifrolumab for Continued Treatment Access

(ROSY-S Trial)

Not yet recruiting at 38 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
Age: Any Age
Sex: Any
Trial Phase: Phase 3
Sponsor: AstraZeneca
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for people who have finished a previous clinical study with anifrolumab (Saphnelo), received at least one dose, and are still benefiting from the treatment. They must complete all required safety checks from their prior study before joining.

Inclusion Criteria

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
I finished the parent study and received at least one dose of anifrolumab.
Contraceptive use by participants should be consistent with local regulations and continue from study enrolment up to 16 weeks after the last dose of study treatment
See 2 more

Exclusion Criteria

I have had an allergic reaction to anifrolumab or its ingredients.
I plan to get a live or weakened live vaccine.
Local access to approved and commercially available reimbursed drug for the defined indication as permitted by local regulation
See 7 more

What Are the Treatments Tested in This Trial?

Interventions

  • Anifrolumab

Trial Overview

The study allows eligible participants to keep receiving anifrolumab as they did in their earlier trial, while closely monitoring for any side effects or safety concerns over time.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: AnifrolumabExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology