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Monoclonal Antibodies

Belimumab for Early Lupus

Phase 4

Recruiting

Led By Cynthia Aranow, MD

Research Sponsored by Northwell Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of SLE per current ACR classification criteria

Concomitant treatment with hydroxychloroquine unless documented inability to tolerate

Must not have

Previous exposure to disease-modifying drugs such as azathioprine, mycophenolate mofetil, cyclophosphamide, or cyclosporine

Previous exposure to biologic therapies including rituximab, belimumab or other agents that have been investigated for SLE

Timeline

Screening 3 weeks

Treatment Varies

Follow Up year 2

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial will study the effects of the drug belimumab on patients with early lupus. Half the patients will receive the drug, while the other half will receive a placebo. The trial will last two years.

Who is the study for?

This trial is for individuals diagnosed with early lupus (within the last 2 years), who have mild to moderate disease activity. Participants must be ANA and anti-ds DNA antibody positive, on stable medication doses, able to consent, and use birth control if of reproductive potential. Exclusions include severe organ dysfunction, certain infections or immunodeficiencies, recent drug abuse, pregnancy/lactation, psychiatric disorders affecting participation.

What is being tested?

The study tests Belimumab's effects on patients with early lupus over two years. In year one, participants are randomly assigned to receive either Belimumab or a placebo. In the second year, those initially given Belimumab may continue it or switch to a placebo. The focus is on clinical outcomes and immune system responses.

What are the potential side effects?

While not specified here, common side effects of Belimumab can include nausea, diarrhea, fever; some may experience infusion reactions like pain or swelling at injection site. Serious but rare risks involve allergic reactions and possible impact on mental health such as depression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with lupus according to ACR criteria.

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I am taking hydroxychloroquine or cannot tolerate it.

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I have tested positive for anti-ds DNA antibodies.

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My ANA test result is positive with a high level.

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I was diagnosed with lupus less than 2 years ago.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have taken drugs like azathioprine or cyclophosphamide before.

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I have been treated with medications like rituximab or belimumab for lupus.

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I have a history of serious, recurring infections.

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I have not received a live vaccine in the last 30 days or while on belimumab.

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I do not have active kidney or nervous system disease.

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I have not taken high doses of steroids in the last 4 weeks.

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My kidney function is low, with a creatinine clearance of 25ml/min or less.

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I am on medication for a long-term infection like TB or herpes.

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I do not have serious heart or lung conditions.

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I was hospitalized for an infection within the last 60 days.

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I've needed steroids twice or more in the last year for my health conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ year 2

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~year 2

This trial's timeline: 3 weeks for screening, Varies for treatment, and year 2 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Frequency of anergic autoreactive naïve B cells

Secondary study objectives

Cardiovascular biomarkers

Complement levels

Damage

+20 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Belimumab/PlaceboExperimental Treatment1 Intervention

Subjects in this arm will receive 200mg belimumab for self administration subcutaneously weekly for 1 year and then placebo injections subcutaneously for 1 year.

Group II: BelimumabActive Control1 Intervention

Subjects in this arm will receive 200mg belimumab for self administration subcutaneously weekly for 2 years

Group III: PlaceboPlacebo Group1 Intervention

Subjects in this arm will receive placebo for self administration subcutaneously weekly for 2 years

0 / 16Eligibility criteria met