Is NCT07430306 recruiting in Menifee, CA?

Yes, NCT07430306 is currently recruiting participants at its Menifee, CA location. This systemic lupus erythematosus clinical trial is actively enrolling qualified participants.

How do I join the systemic lupus erythematosus clinical trial in Menifee?

To join this clinical trial in Menifee, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Menifee clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Systemic Lupus Erythematosus Clinical Trial in Menifee, CA

About This Systemic Lupus Erythematosus Study in Menifee

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.

Sponsor: AstraZeneca

Who Can Participate

Inclusion Criteria

Males or females aged 18 to 70 years of age.

Participants who have a diagnosis of SLE confirmed by a rheumatologist.

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

Must be on the standard therapy regimen: antimalarials with or without OCSs

Must have at screening and baseline:

Clinical SLEDAI-2K ≥ 4 points OR

Clinical SLEDAI-2K \< 4 with GC dose ≥ 7.5 mg/day (prednisone equivalent)

Should have no evidence of current active infection, (e.g., pneumonia, tuberculosis \[TB\]) or previous TB

Should have no evidence of malignancy; and clinically significant abnormalities (unless due to SLE).

No medical history or signs or symptoms of active TB prior to or during Screening.

Body weight ≥ 40.0 kg

Negative pregnancy test for females during screening

Normal HPV test result within 2 years prior to Week 0 (Day 1).

Willing and able to participate in all required study evaluations and procedures including completion of PROs.

Willing to not use any other forms of experimental treatment during the study.

Exclusion Criteria

Subjects with history of, or current diagnosis of, a clinically significant non-SLE related vasculitis syndrome.

Subjects with antiphospholipid antibody syndrome on stable anticoagulant therapy at an effective dose (e.g., if on warfarin, an international normalized ratio \[INR\] target 2 to 3 or as appropriate for the clinical situation) are only allowed if this is not the sole or the predominant feature of their SLE.

Subjects with a serious thrombotic event (e.g., pulmonary embolism stroke, deep vein thrombosis) or unexplained pregnancy loss within 1 year before the screening visit are excluded.

Subjects with a history of catastrophic antiphospholipid syndrome or saddle embolism.

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

History or evidence of suicidal ideation within the past 6 months; or any suicidal behavior within the past 12 months or recurrent suicidal behavior in the lifetime of the participant based on an assessment with the Columbia Suicide Severity Rating Scale (C SSRS) at Screening.

Active severe or unstable neuropsychiatric SLE including, but not limited to aseptic meningitis, cerebral vasculitis, myelopathy, demyelination syndromes (ascending, transverse, acute inflammatory demyelinating polyradiculopathy), acute confusional state, impaired level of consciousness, psychosis, acute stroke or stroke syndrome, cranial neuropathy, status epilepticus, cerebellar ataxia, lupus headache and mononeuritis multiplex, where, protocol-specified standard therapy is insufficient.

Active severe SLE-driven renal disease where, protocol-specified standard therapy is insufficient.

Current diagnosis of, catastrophic antiphospholipid syndrome (APS).

History of recurrent infection requiring hospitalization and IV antibiotics (e.g., 3 or more of the same type of infection over the previous 52 weeks).

Known History of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection, or a positive result for HIV at Screening.

Confirmed positive test for hepatitis B.

Any clinical cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection that has not completely resolved within 12 weeks prior to signing the ICF.

Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years of Week 0 (Day 1).

Clinically significant chronic infection (e.g., osteomyelitis, bronchiectasis, etc.) within 8 weeks prior to signing the ICF (chronic nail infections are allowed).

Severe HZ or recurrent HZ.

Malignancy. History of cancer, apart from: (a) Squamous or basal cell carcinoma of the skin treated with documented success of curative therapy ≥ 3 months prior to Week 0 (Day 1). (a) Cervical cancer in situ treated with apparent success with curative therapy ≥ 1 year prior to Week 0 (Day 1).

Received any SLE-related therapies other than antimalarials and GCs.

History of allergy or reaction to any component of the study intervention formulation or history of anaphylaxis to any human gamma globulin therapy.

History of an anaphylactic reaction to human proteins or mAbs.

Received any live or attenuated vaccine within 8 weeks prior to signing the ICF.

Blood transfusion or receipt of blood products except albumin.

Received more than 2 investigational products for the SLE since time of diagnosis.

Received any investigational product (small molecule or biologic agent) within 4 weeks or 5 half-lives prior to signing of the ICF, whichever is greater.

Concurrent enrollment in another clinical study with a study intervention.

Subjects with any abnormal lab result as specified in the protocol.

Subjects with other autoimmune diseases (e.g., multiple sclerosis, psoriasis, IBD, etc.).

Subjects with SLE overlap syndromes such as scleroderma and mixed connective tissue disease.

Subject with non-SLE concomitant illness, as determined by medical judgment, who is likely to require additional systemic glucocorticosteroid therapy during the study (e.g., asthma).

Any condition would interfere with treatment outcomes of the study intervention or put participant at safety risk.

Lactating, breastfeeding, or pregnant females or females who intend to become pregnant or begin breastfeeding anytime from initiation of Screening until 16 weeks following last dose of study intervention.

Spontaneous or induced abortion, still or live birth, or pregnancy ≤ 4 weeks prior to signing the ICF.

Current alcohol, drug or chemical abuse, or a history of such abuse within 1 year before Week 0 (Day 1).

Major surgery within 8 weeks before signing the ICF or elective major surgery planned during the study period.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Menifee?

Yes, this clinical trial (NCT07430306) has an active research site in Menifee, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Systemic Lupus Erythematosus Treatment Options in Menifee, CA

If you're searching for systemic lupus erythematosus treatment options in Menifee, CA, this clinical trial (NCT07430306) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Menifee research site is actively enrolling participants for this clinical trial. You'll receive care from experienced systemic lupus erythematosus specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all systemic lupus erythematosus clinical trials near you to find additional studies recruiting in your area.

Systemic Lupus Erythematosus Clinical Trial in Menifee, CA

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