Rollover Study for Participants Who Have Completed a Previous Clinical Study With Anifrolumab (Saphnelo) and Clinically Benefited From Continued Treatment
Public ClinicalTrials.gov record NCT07691970. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07691970
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,072 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 5 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2026 (Actual)
- Primary completion
- Dec 30, 2032 (Estimated)
- Completion
- Dec 30, 2032 (Estimated)
- Last update posted
- Oct 2, 2026
2026 – 2032
United States locations
- U.S. sites
- 15
- U.S. states
- 13
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Phoenix | Arizona | 85028 | Not yet recruiting |
| Research Site | Los Angeles | California | 90045 | Recruiting |
| Research Site | San Francisco | California | 94115 | Not yet recruiting |
| Research Site | Boca Raton | Florida | 33486 | Not yet recruiting |
| Research Site | Fort Lauderdale | Florida | 33309 | Not yet recruiting |
| Research Site | Chicago | Illinois | 60611 | Not yet recruiting |
| Research Site | Ann Arbor | Michigan | 48109 | Not yet recruiting |
| Research Site | Rochester | Minnesota | 55905 | Not yet recruiting |
| Research Site | Omaha | Nebraska | 68114 | Not yet recruiting |
| Research Site | New York | New York | 10029 | Not yet recruiting |
| Research Site | Charlotte | North Carolina | 28202 | Not yet recruiting |
| Research Site | Cleveland | Ohio | 44195 | Not yet recruiting |
| Research Site | Portland | Oregon | 97239 | Not yet recruiting |
| Research Site | Charleston | South Carolina | 29425 | Not yet recruiting |
| Research Site | Roanoke | Virginia | 24016 | Not yet recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 113 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07691970, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 2, 2026 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07691970 live on ClinicalTrials.gov.