Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Anifrolumab for Systemic Sclerosis Cutaneous Lupus E Myopathies Systemic Lupus Erythematosus

This study wants 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 whether it is safe and how hard side effects are to live with. 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.

Official registry: https://clinicaltrials.gov/study/NCT07691970 · AstraZeneca · enrollment listed as 1,072

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Anifrolumab, Anifrolumab, or Anifrolumab. The registry lists allocation as randomized. This study wants 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 whether it is safe and how hard side effects are to live with.

They plan to enroll about 1,072 people at 142 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: Anifrolumab, Anifrolumab, Anifrolumab

Primary outcome (registry wording): SAEs and Non-Serious AEs

Who it is for (from inclusion criteria)

  • Ages 5 Years to 80 Years
  • 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
  • Capable of adhering to the treatment plan related to this ROSY-S study

Public study contact (from the registry)

AstraZeneca Clinical Study Information Center

+1877-240-9479

information.center@astrazeneca.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

142 listed

+ 121 sites outside the US on the same record

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FAQ about this NCT record

Is NCT07691970 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07691970?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07691970?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary