What side effects are associated with this type of intervention?

Common treatments for Lupus, particularly monoclonal antibodies like Antifrolumab, include Belimumab and Rituximab. The known side effects of these treatments can include infusion reactions (such as rash, pruritus, and urticaria), increased risk of infections (e.g., pneumonia, cellulitis), and potential for serious adverse effects like hypersensitivity reactions. Additionally, patients may experience mild to moderate injection site reactions, and there is a small risk of neurocognitive symptoms. Monitoring for these side effects is crucial to manage and mitigate risks effectively.

What prior FDA approvals exist?

The FDA has approved several biologic therapies for the treatment of systemic lupus erythematosus (SLE). One notable example is Belimumab, a monoclonal antibody that inhibits B-lymphocyte stimulator (BLyS) and has shown efficacy, safety, and tolerability in clinical trials. Another biologic therapy, Rituximab, targets CD20 on B cells but has not demonstrated superiority over placebo in terms of efficacy for SLE. These treatments, like Anifrolumab, represent targeted approaches to modulating the immune system in lupus patients.

What other types of research exist?

Promising novel alternatives to Antifrolumab for Lupus patients include Belimumab (a monoclonal antibody targeting B-lymphocyte stimulator), Rituximab (a monoclonal antibody targeting CD20 on B cells), and Anifrolumab (another monoclonal antibody targeting type I interferon receptor). Additionally, therapies like Voclosporin (a calcineurin inhibitor) and novel JAK inhibitors are also being explored for their potential benefits in treating Lupus.

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Monoclonal Antibodies

Subcutaneous Anifrolumab for Lupus (Tulip SC Trial)

Phase 3

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

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

Must have

BILAG2004 level A disease in ≥ 1 organ system

BILAG2004 level B disease in ≥ 2 organ systems

Must not have

Active severe SLE-driven renal disease

Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years of randomization.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years 4 months

Awards & highlights

Pivotal Trial

Summary

This trial is testing an injectable medication called anifrolumab in adults with moderate-to-severe lupus who haven't fully responded to standard treatments. Anifrolumab works by reducing the immune system's attack on the body to help lessen lupus symptoms. It has been approved for the treatment of moderate to severe systemic lupus erythematosus (SLE) based on evidence from various studies.

Who is the study for?

Adults with moderate-to-severe Systemic Lupus Erythematosus (SLE) who've had it for at least 24 weeks and are on stable SLE medications can join. They need a certain level of disease activity and positive tests for specific lupus antibodies. People with severe, unstable SLE, recent serious infections or hospitalizations, immune deficiencies including HIV, hepatitis B or C, certain cancers, or those treated with high-dose steroids recently cannot participate.

What is being tested?

The trial is testing Anifrolumab given under the skin to see if it's effective and safe in adults with SLE who aren't getting better with standard treatments. Participants will either receive Anifrolumab or a placebo without knowing which one they're getting to compare results fairly.

What are the potential side effects?

Anifrolumab may cause reactions where the injection was given, increase the risk of common infections like colds or urinary tract infections, and possibly lead to more serious issues such as pneumonia. Some people might feel tiredness or have allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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My lupus is severely affecting at least one organ.

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My lupus affects at least two organ systems moderately.

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I have severe lupus affecting at least one organ.

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My lupus affects at least one major organ or two other organs, and I have positive lupus antibodies.

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My blood test showed positive for specific autoimmune markers.

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My lupus affects at least two organ systems moderately.

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I have been diagnosed with erythematosus.

Exclusion Criteria

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

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I have severe kidney problems due to lupus.

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I have not been hospitalized for an infection needing IV treatment in the last 3 years.

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I've been hospitalized 3+ times for the same infection in the last year.

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I have severe or unstable mental health issues due to lupus.

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I haven't taken steroids for more than 2 weeks in the last 6 months, except for SLE.

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I have never had a severe case of shingles.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years 4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years 4 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response

Secondary study objectives

Annualized flare rate

BICLA response with maintained low (or reduced) use of oral corticosteroid (OCS)

Maintained oral corticosteroid (OCS) reduction among patients with baseline OCS ≥10 mg/day.

+3 more

Other study objectives

Adverse Event Overview

Awards & Highlights

Pivotal Trial

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

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: AnifrolumabExperimental Treatment1 Intervention

Solution for injection in aPFS

Group II: PlaceboPlacebo Group1 Intervention

Solution for injection in aPFS

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for lupus, such as hydroxychloroquine, glucocorticoids, and immunosuppressive agents, work by modulating the immune system to reduce inflammation and prevent organ damage. Hydroxychloroquine interferes with antigen presentation and cytokine production, while glucocorticoids suppress overall immune activity. Immunosuppressive agents like azathioprine inhibit DNA synthesis, reducing the proliferation of immune cells. Anifrolumab, a monoclonal antibody targeting the type I interferon receptor, blocks the activity of interferons, which are proteins that play a key role in the inflammatory process of lupus. This targeted approach is significant for lupus patients as it offers a more precise method to control disease activity and potentially reduce side effects compared to broader immunosuppressive therapies.

Preventing organ damage in systemic lupus erythematosus: the impact of early biological treatment.[Neuropsychiatric Systemic Lupus Erythematosus].