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NCT07691970 · ClinicalTrials.gov registry record · Phase 3
Rollover Study for Participants Who Have Completed a Previous Clinical Study With Anifrolumab (Saphnelo) and Clinically Benefited From Continued Treatment
A Phase 3 study, sponsored by AstraZeneca.
- Not yet
- Registry status
- Phase 3
- Development phase
- 1,072
- Enrollment target
NCT07691970 is a Phase 3 study that has not yet begun recruiting, run by AstraZeneca. The registered enrollment target is 1,072 participants.
The verdict
NCT07691970, a Phase 3 study, has not yet begun recruiting, sponsored by AstraZeneca.
- NOT YET RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,072 participants
- Enrollment target
Study 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.
Interventions
- DRUG Anifrolumab
- COMBINATION_PRODUCT Anifrolumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,072 participants |
| Start Date | 2026-09-01 |
| Est. Completion | 2032-12-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07691970
The ClinicalTrials.gov registry entry for NCT07691970 describes a study currently listed as not yet recruiting, categorized as Phase 3. The registered enrollment target is 1,072 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Anifrolumab is the first listed.
NCT07691970 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07691970 about?
NCT07691970 is a clinical study titled "Rollover Study for Participants Who Have Completed a Previous Clinical Study With Anifrolumab (Saphnelo) and Clinically Benefited From Continued Treatment". 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: * P...
What is the current status of trial NCT07691970?
This trial is currently not yet recruiting. It is a Phase 3 study. The enrollment target is 1,072 participants. The study started on 2026-09-01. Estimated completion is 2032-12-31.
What interventions are being tested in trial NCT07691970?
The interventions under investigation include: Anifrolumab (DRUG), Anifrolumab (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT07691970?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
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