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NCT07430306 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Treatment Outcomes of Subcutaneous Anifrolumab in Immunosuppressant-naïve and Biologic-naïve Systemic Lupus Erythematosus
A Phase 3 study, sponsored by AstraZeneca.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 245
- Enrollment target
NCT07430306: Recruiting Phase 3 study, sponsored by AstraZeneca.
NCT07430306 is a Phase 3 study that is actively recruiting participants, run by AstraZeneca. The registered enrollment target is 245 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07430306, a Phase 3 study, is actively recruiting participants, sponsored by AstraZeneca.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 245 participants
- Enrollment target
Study Summary
The purpose of the SUNFLOWER study is to describe clinical outcomes, including DORIS remission, achieved following the initiation of anifrolumab 120 mg SC once weekly (QW) as add-on therapy to an anti-malarial, with or without GC; in patients not in LLDAS at enrolment. Patients will be naïve to any prior conventional immunosuppressant including prior biologic therapy at enrolment. The study will also employ a tapering protocol for a systematic approach to GC tapering, seeking to understand better the proportion of patients in remission who can successfully withdraw chronic GC completely.
Primary Outcome
Proportion of participants who are in DORIS remission at Week 52 will be assessed. DORIS remission is defined as Clinical SLEDAI-2K (sum of all SLEDAI-2K items except for increased deoxyribonucleic acid \[DNA\] binding and low complement) = 0; PGA \[0-3\] \< 0.5, prednisone 5 mg/day or less, and stable antimalarials, ISs, and biologics.
Interventions
- DRUG Anifrolumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 245 participants |
| Start Date | 2026-04-13 |
| Est. Completion | 2029-01-26 |
| Phase | Phase 3 |
What NCT07430306 shows while recruiting
NCT07430306 is an interventional study that assigns participants to a tested intervention. The registered 245 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 1 intervention - of which Anifrolumab is the first listed.
NCT07430306 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07430306 about?
NCT07430306 is a clinical study titled "A Study to Evaluate the Treatment Outcomes of Subcutaneous Anifrolumab in Immunosuppressant-naïve and Biologic-naïve Systemic Lupus Erythematosus". The purpose of the SUNFLOWER study is to describe clinical outcomes, including DORIS remission, achieved following the initiation of anifrolumab 120 mg SC once weekly (QW) as add-on therapy to an anti-malarial, with or without GC; in patients not in LLDAS at enrolment. Patients will be naïve to any...
What is the current status of trial NCT07430306?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 245 participants. The study started on 2026-04-13. Estimated completion is 2029-01-26.
What interventions are being tested in trial NCT07430306?
The interventions under investigation include: Anifrolumab (DRUG).
Who is sponsoring clinical trial NCT07430306?
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 NCT07430306's enrollment target sits among peer trials
245 1267th of 2000 higher than 732 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
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