Anifrolumab for Lupus

(SUNFLOWER Trial)

Recruiting at 56 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AstraZeneca

Must be taking: Antimalarials

Must not be taking: Immunosuppressants, Biologics

Disqualifiers: Vasculitis, Thrombotic events, APS, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

245 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

ANA-positive per the Central Lab at screening: ANA, Anti-dsDNA, Anti-Smith (anti-Sm)

I have no signs of cancer or major health issues, unless caused by my lupus.

Negative pregnancy test for females during screening

Exclusion Criteria

Subjects with a serious thrombotic event or unexplained pregnancy loss within 1 year before the screening visit

Subjects with a history of catastrophic antiphospholipid syndrome or saddle embolism

Subjects with a history of 3 or more unexplained consecutive pregnancy losses

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

5 weeks

Treatment

Participants receive anifrolumab 120 mg subcutaneously once weekly for 52 weeks

52 weeks

Weekly visits for dosing

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Safety follow-up after last dose

What Are the Treatments Tested in This Trial?

Interventions

• Anifrolumab

How Is the Trial Designed?

Group I: Anifrolumab Experimental Treatment 1 Intervention

Participants will receive dose A of anifrolumab on X dosing schedule beginning on Day 1 for a maximum of 52 -week during the study

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

ICON plc

Industry Sponsor

Trials

88

Recruited

28,900+

Dr. Steve Cutler

ICON plc

Chief Executive Officer since 2017

PhD from the University of Sydney, MBA from the University of Birmingham

Dr. Greg Licholai

ICON plc

Chief Medical Officer since 2023

Degrees from Harvard Business School, Yale School of Medicine, Columbia University, and Boston College