Multinational, Interventional, 52-week, Open-label, Single-arm Study to Evaluate the Treatment Outcomes of Anifrolumab 120 mg Subcutaneous Once Weekly in Immunosuppressant-naïve and Biologic-naïve Systemic Lupus Erythematosus (SUNFLOWER)

AstraZeneca

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.

Description

In this study, approximately 275 participants will be enrolled and the study duration will be up to approximately 69 weeks, including: A Screening Period lasting up to 35 days and A 52-week treatment period. Also, participants not continuing treatment with any preparation of anifrolumab after Week 52 will have additional safety follow up 12 weeks after last dose of anifrolumab. Anifrolumab will be administered SC via an aPFS during the 52-week Study. The study population will comprise participants taking antimalarial with or without GCs (there is a recruitment cap of 50% of patients not on GC…

Eligibility

Age range: 18–70 years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: 1. Males or females aged 18 to 70 years of age. 2. Participants who have a diagnosis of SLE confirmed by a rheumatologist. 3. ANA-positive per the Central Lab at screening: (a) ANA (b) Anti-dsDNA (c) Anti-Smith (anti-Sm) 4. Must be on the standard therapy regimen: antimalarials with or without OCSs 5. Must have at screening and baseline: 1. Clinical SLEDAI-2K ≥ 4 points OR 2. Clinical SLEDAI-2K \< 4 with GC dose ≥ 7.5 mg/day (prednisone equivalent) 6. Should have no evidence of current active infection, (e.g., pneumonia, tuberculosis \[TB\]) or previous TB 7. Sh…

Interventions

Drug
Anifrolumab
Patients will receive Anifrolumab subcutaneous

Locations (73)

Research Site
Anniston, Alabama
Research Site
Phoenix, Arizona
Research Site
Fontana, California
Research Site
La Palma, California
Research Site
Menifee, California
Research Site
San Leandro, California