What is the mechanism of action of this treatment?

Common treatments for lupus, particularly those focusing on immune modulation, include glucocorticoids, hydroxychloroquine, and biologics such as B cell-targeted therapies and JAK inhibitors. Glucocorticoids reduce inflammation by suppressing the immune response, while hydroxychloroquine interferes with immune cell communication to decrease disease activity. Biologics, including B cell-targeted therapies, work by inhibiting specific components of the immune system that contribute to lupus pathology. JAK inhibitors block signaling pathways involved in immune activation. These treatments are essential for lupus patients as they help control symptoms, prevent organ damage, and improve quality of life.

What side effects are associated with this type of intervention?

Common treatments for Lupus, particularly those involving immune modulation such as biologic agents and B-cell targeted therapies, often come with a range of side effects. These can include infusion reactions, increased susceptibility to infections, and potential neuropsychiatric side effects. Specific agents like rituximab have been associated with serum-sickness-like reactions, infusion reactions, and in rare cases, progressive multifocal encephalopathy. Glucocorticoids, often used in combination with these therapies, can lead to hyperglycemia, bone loss, and increased infection risk. Overall, while these treatments can be effective, they require careful monitoring for adverse effects.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Lupus that focus on immune modulation. Belimumab, an immunoglobulin G1-lambda monoclonal antibody, was the first drug approved in over 50 years specifically for systemic lupus erythematosus (SLE). It works by inhibiting the activity of B-lymphocyte stimulator (BLyS), reducing the survival of B cells. Rituximab, a chimeric anti-CD20 monoclonal antibody, is also used off-label for refractory SLE, targeting B cells to reduce their activity. These treatments aim to modulate the immune system to control the disease's activity and symptoms.

What other types of research exist?

Promising novel alternatives to ESK-001 for Lupus patients include belimumab, which has confirmed efficacy and safety in SLE, and other agents such as blisibimod, sifalimumab, anifrolumab, and ustekinumab, which have shown promising results in phase II trials. Additionally, rituximab has extensive clinical experience and shows favorable responses in refractory SLE cases.

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Monoclonal Antibodies

ESK-001 for Lupus (LUMUS Trial)

Verified Trial

Phase 2

Recruiting

Research Sponsored by Alumis Inc

Eligibility Criteria Checklist

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

Must have

Azathioprine ≤200 mg/day

Mycophenolate mofetil ≤2 g/day or mycophenolic acid ≤1.44 g/day

Must not have

Active severe or unstable neuropsychiatric SLE including, but not limited to the following: aseptic meningitis; cerebral vasculitis; myelopathy; demyelination syndromes (ascending or transverse myelitis, acute inflammatory demyelinating polyradiculopathy); acute confusional state; impaired level of consciousness; psychosis; acute stroke or stroke syndrome; cranial neuropathy; new seizures; cerebellar ataxia; and mononeuritis multiplex.

Known history of a primary immunodeficiency or an underlying condition such as HIV infection or splenectomy that predisposes the patient to infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 48

Awards & highlights

Summary

This trial is testing a new medication called ESK-001 to see if it can help adults with SLE, a chronic autoimmune disease. The study will check the effectiveness and safety of ESK-001 over several months.

Who is the study for?

Adults with active Systemic Lupus Erythematosus (SLE) for at least 6 months, meeting specific disease criteria and on stable medications like Azathioprine or Methotrexate. Excluded are those with chronic infections, other autoimmune diseases that could affect results, recent use of oral anti-infectives, severe unrelated conditions, or a history of significant neuropsychiatric SLE.

What is being tested?

The trial is testing the effectiveness and safety of multiple doses of a new drug called ESK-001 against a placebo in adults with SLE. It will compare how well each treatment works and monitor any changes in the disease's activity and severity.

What are the potential side effects?

While not specified here, potential side effects may include typical drug reactions such as nausea, headaches, possible increased risk of infection due to immune system impact by ESK-001. The study aims to identify these side effects.

Eligibility Criteria

Inclusion Criteria

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

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I take 200 mg or less of Azathioprine daily.

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I am taking no more than 2g of mycophenolate mofetil or 1.44g of mycophenolic acid daily.

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I am taking methotrexate, but no more than 20 mg per week.

Exclusion Criteria

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

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I have severe or unstable brain or nerve problems due to lupus.

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I have a condition like HIV or have had my spleen removed, which makes me more prone to infections.

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I have a serious infection right now.

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I have had a severe herpes infection before.

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I have not had a shingles infection in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 48

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 48

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 48 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

To compare the effect on disease activity measured by the proportion of patients achieving British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) response at Week 48 between doses of ESK-001 and placebo

Secondary study objectives

To assess the safety and tolerability of multiple dose levels of ESK-001

To compare Fatigue measured by FACIT-F between doses of ESK-001 and placebo

To compare corticosteroid use in patients at Week 48

+9 more

Side effects data

From 2023 Phase 2 trial • 228 Patients • NCT05600036

Upper respiratory tract infection

Nasopharyngitis

Diabetes mellitus

Dermatitis acneiform

Lower limb fracture

Diarrhea

100%

80%

60%

40%

20%

Study treatment Arm

ESK-001 10mg QD

ESK-001 20mg QD

ESK-001 40mg QD

ESK-001 20mg BID

ESK-001 40mg BID

Placebo

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: ESK-001 Dose Level 3Experimental Treatment1 Intervention

ESK-001 administered as an oral tablet

Group II: ESK-001 Dose Level 2Experimental Treatment1 Intervention

ESK-001 administered as an oral tablet

Group III: ESK-001 Dose Level 1Experimental Treatment1 Intervention

ESK-001 administered as an oral tablet

Group IV: PlaceboPlacebo Group1 Intervention

Placebo administered as an oral tablet

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ESK-001

2022

Completed Phase 2

~250

0 / 8Eligibility 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, particularly those focusing on immune modulation, include glucocorticoids, hydroxychloroquine, and biologics such as B cell-targeted therapies and JAK inhibitors. Glucocorticoids reduce inflammation by suppressing the immune response, while hydroxychloroquine interferes with immune cell communication to decrease disease activity. Biologics, including B cell-targeted therapies, work by inhibiting specific components of the immune system that contribute to lupus pathology. JAK inhibitors block signaling pathways involved in immune activation. These treatments are essential for lupus patients as they help control symptoms, prevent organ damage, and improve quality of life.

[Neuropsychiatric Systemic Lupus Erythematosus].A Systems Biology-Based Investigation into the Pharmacological Mechanisms of Sheng-ma-bie-jia-tang Acting on Systemic Lupus Erythematosus by Multi-Level Data Integration.Is B Cell-Targeted Therapy Effective in Systemic Lupus Erythematosus?