A Study to Evaluate the Treatment Outcomes of Subcutaneous Anifrolumab in Immunosuppressant-naïve and Biologic-naïve Systemic Lupus Erythematosus

Part of paid clinical trials in Anniston, Alabama.

Sponsor
AstraZeneca
Study ID
NCT07430306
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Anifrolumab — DRUG
    Patients will receive Anifrolumab subcutaneous

Study Details

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.

Key Dates

Start date
Apr 13, 2026
Status verified
May 2026
Primary completion
Jan 26, 2029
Completion
Jan 26, 2029

Study Design

Enrollment
245 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Attainment of DORIS remission [ Time Frame: At Week 52 ]

Central Contacts

Locations (25)

FacilityCityStateZIPSite coordinators
Research SiteAnnistonAlabama36207-
Research SitePhoenixArizona85032-
Research SiteFontanaCalifornia92335-
Research SiteLa PalmaCalifornia90623-
Research SiteMenifeeCalifornia92586-
Research SiteSan LeandroCalifornia94578-
Research SiteTemeculaCalifornia92592-
Research SiteBrandonFlorida33511-
Research SiteMiamiFlorida33136-
Research SiteMiamiFlorida33145-
Research SiteMiamiFlorida33180-
Research SiteWillowbrookIllinois60527-
Research SiteNew AlbanyIndiana47150-
Research SiteLake CharlesLouisiana70605-
Research SiteKansas CityMissouri64151-
Research SiteOklahoma CityOklahoma73116-
Research SiteMemphisTennessee38104-
Research SiteMemphisTennessee38119-
Research SiteAustinTexas78745-
Research SiteBaytownTexas77521-
Research SiteColleyvilleTexas76034-
Research SiteEdinburgTexas78550-
Research SiteHoustonTexas77054-
Research SiteSugar LandTexas77479-
Research SiteSpokaneWashington99204-

Find similar trials in Anniston, AL

By condition
Lupus (SLE)
By specialty
RheumatologyAutoimmune disease
By research site
Research Site· Anniston, ALResearch Site· Phoenix, AZResearch Site· Fontana, CAResearch Site· La Palma, CAResearch Site· Menifee, CAResearch Site· San Leandro, CA

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