What side effects are associated with this type of intervention?

Common treatments for Lupus, such as biologic agents and immunosuppressants, have a range of side effects. Rituximab can cause infusion reactions, serum-sickness-like reactions, and in rare cases, progressive multifocal encephalopathy. Methotrexate may lead to gastrointestinal distress, hepatotoxicity, hematologic toxicity, and pulmonary toxicity, and it is teratogenic. Other biologics, like IL-23 inhibitors, can cause nasopharyngitis, headache, and injection site reactions. Monitoring for adverse effects is crucial during treatment.

What prior FDA approvals exist?

Belimumab is an FDA-approved biologic therapy for the treatment of systemic lupus erythematosus (SLE). It has shown a satisfactory profile in terms of efficacy, safety, and tolerability. Other biologic agents such as rituximab have been studied, but they did not demonstrate significant superiority over placebo in terms of efficacy for SLE treatment. These biologic therapies target different pathways in the immune system to help manage lupus symptoms and disease activity.

What other types of research exist?

Promising novel alternatives to Daxdilimab for Lupus patients in 2024 include: 1) Anifrolumab, a monoclonal antibody targeting the type I interferon receptor, which has shown efficacy in reducing disease activity in SLE. 2) Belimumab, a monoclonal antibody that inhibits B-lymphocyte stimulator (BLyS), approved for SLE and showing long-term benefits. 3) Voclosporin, a calcineurin inhibitor recently approved for lupus nephritis, demonstrating significant improvement in renal outcomes. These alternatives offer different mechanisms of action and have shown promising results in clinical trials.

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Monoclonal Antibodies

Daxdilimab for Lupus (RECAST SLE OLE Trial)

Phase 2

Waitlist Available

Research Sponsored by Amgen

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 0 (week 0 = day 1), week 12, week 24, week 36, week 48, week 56

Awards & highlights

No Placebo-Only Group

Summary

This trial tests daxdilimab, an injectable medication, on people with lupus to see if it is safe and can be tolerated over time. The medication works by reducing the immune system's harmful activity.

Who is the study for?

This trial is for individuals who have completed the RECAST SLE study for Systemic Lupus Erythematosus. Participants must be able to consent, use contraception if of childbearing potential, and not have any health changes that could affect the trial's safety or results.

What is being tested?

The study tests Daxdilimab's long-term safety and effectiveness in treating Systemic Lupus Erythematosus. It's an open-label extension, meaning all participants know they're receiving Daxdilimab after finishing the initial RECAST SLE study.

What are the potential side effects?

While specific side effects are not listed here, common risks may include immune system reactions, infections due to lowered immunity, infusion-related reactions, and possible impacts on liver function.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 0 (week 0 = day 1), week 12, week 24, week 36, week 48, week 56

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 0 (week 0 = day 1), week 12, week 24, week 36, week 48, week 56

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0 (week 0 = day 1), week 12, week 24, week 36, week 48, week 56 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of Participants Who Experienced AEs of Special Interest (AESI)

Number of Participants Who Experienced Serious Adverse Events (SAEs)

Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)

Secondary study objectives

Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Count

Number of Participants Expressing Anti-drug Antibodies (ADA)

Serum Concentration of Daxdilimab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: DaxdilimabExperimental Treatment1 Intervention

Daxdilimab injections over a total of 48 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Daxdilimab

Not yet FDA approved

Do I qualify?Apply below to find out

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 systemic lupus erythematosus (SLE) include hydroxychloroquine, glucocorticoids, and biologic agents like belimumab and anifrolumab. Hydroxychloroquine works by modulating the immune system and reducing inflammation, which helps control lupus symptoms and prevent flares. Glucocorticoids suppress the immune response and inflammation, providing rapid relief from severe symptoms. Biologic agents, such as belimumab, target specific components of the immune system, like B lymphocytes, to reduce disease activity. These treatments are crucial for lupus patients as they help manage symptoms, prevent organ damage, and improve quality of life by controlling the overactive immune response characteristic of lupus.

Preventing organ damage in systemic lupus erythematosus: the impact of early biological treatment.The Role of Neutrophils and Neutrophil Extracellular Traps in Vascular Damage in Systemic Lupus Erythematosus.Unmet Needs in the Pathogenesis and Treatment of Systemic Lupus Erythematosus.