Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Clinical Trial Phase 3 study, sponsored by AstraZeneca.
NCT07691970 is a Phase 3 study that has not yet begun recruiting, run by AstraZeneca. The registered enrollment target is 1,072 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (39% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Safety will be evaluated by monitoring and assessing SAEs and Non-Serious AEs as reported throughout the study and until 12 weeks after the last dose of anifrolumab
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 |
What is known before NCT07691970 opens enrollment
NCT07691970 is an interventional study that assigns participants to a tested intervention. Its 1,072 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (39% higher).
The record links to 0 conditions, and to 2 interventions - of which Anifrolumab is the first listed.
NCT07691970 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07691970's enrollment target sits among peer trials
1,072 272nd of 2000 higher than 1,729 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06751043 · 1,072 participants · NA
Preoperative Fasting vs. Not Fasting in Critically Ill Patients
- NCT06159673 · 1,074 participants · Phase 2
ACP-204 in Adults With Alzheimer's Disease Psychosis
- NCT06658808 · 1,075 participants · NA
Efficacy-Implementation Study for PC CARES in Rural Alaska
- NCT07084883 · 1,076 participants
Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI