What side effects are associated with this type of intervention?

Common treatments for Systemic Lupus Erythematosus (SLE) that target immune pathways, such as immunosuppressive drugs and biologics, often have a range of side effects. These can include mild to moderate adverse events like fatigue, nausea, joint pain, and headaches. More serious side effects may include increased susceptibility to infections, infusion-related reactions, and potential organ toxicity. For example, treatments like CDP7657 have reported serious adverse events such as herpes zoster infection and infusion reactions. It is important for patients to discuss these potential risks with their healthcare provider to manage and mitigate side effects effectively.

What prior FDA approvals exist?

Belimumab is a notable FDA-approved drug for the treatment of Systemic Lupus Erythematosus (SLE), targeting the B-lymphocyte stimulator (BLyS) pathway to reduce disease activity. Other treatments that modulate the immune system include hydroxychloroquine, corticosteroids, and immunosuppressive agents like azathioprine and mycophenolate mofetil. These therapies aim to control the overactive immune response characteristic of SLE.

What other types of research exist?

Promising novel alternatives to SAR441344 for SLE treatment include anifrolumab, a monoclonal antibody targeting the type I interferon receptor, and belimumab, a monoclonal antibody that inhibits B-lymphocyte stimulator (BLyS). Both therapies modulate immune pathways implicated in SLE and have shown efficacy in clinical trials.

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SAR441344 for Lupus (APATURA Trial)

Phase 2

Recruiting

Research Sponsored by Sanofi

Eligibility Criteria Checklist

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

Must have

Diagnosis of SLE for at least 6 months prior to screening by fulfilling the Revised Criteria for Classification of SLE according to the 1997 Update of the 1982 ACR criteria

Body weight within 45 kg to 120 kg (inclusive) at screening

Must not have

Previous parenteral (IV), intramuscular (IM), or intra-articular steroid administration within 4 weeks prior to randomization

Evidence of active or untreated latent tuberculosis as documented by medical history (eg, chest X-rays) and examination, and tuberculosis testing

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at week 24

Summary

This trial is testing a new drug called SAR441344 to see if it can help adults aged 18-70 with active Systemic Lupus Erythematosus (SLE). The drug aims to reduce symptoms by calming the immune system.

Who is the study for?

Adults aged 18-70 with active Systemic Lupus Erythematosus (SLE) can join this trial. They must have been diagnosed at least 6 months ago, be on standard SLE care, and meet certain disease activity levels. Participants need to weigh between 45-120 kg and use approved contraception methods. Those with drug-induced lupus, other major diseases that could affect the study, recent high-dose steroids or immunosuppressants, serious infections or a history of severe lupus complications cannot participate.

What is being tested?

The trial is testing SAR441344's effectiveness in treating SLE against a placebo. It's given either intravenously (IV) or subcutaneously (SC). Over 36 weeks, participants will receive treatment for half that time and visit the clinic every two weeks to compare how well SAR441344 works compared to no active treatment.

What are the potential side effects?

While specific side effects are not listed here, clinical trials like this one typically monitor for any adverse reactions related to the immune system due to the nature of treatments being tested for autoimmune conditions like SLE.

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 for at least 6 months.

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My weight is between 45 kg and 120 kg.

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My lupus severity score is 6 or more, with symptoms including arthritis and rash.

Exclusion Criteria

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

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I haven't had steroid injections or IVs in the last 4 weeks.

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I do not have active or untreated latent tuberculosis.

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I do not have a serious infection.

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

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I have had serious infections like histoplasmosis or candidiasis.

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I haven't taken high doses of immunosuppressants or changed my dose in the last 3 months.

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I have severe kidney inflammation due to lupus.

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I have a history of or currently have low levels of antibodies.

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I have not used cyclophosphamide in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 24 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Percentage of participants who achieved a Systemic Lupus Erythematosus Responder Index (SRI-4) response at Week 24.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: FrexalimabExperimental Treatment2 Interventions

Frexalimab intravenous (IV) loading dose followed by subcutaneous (SC) doses, 24 weeks

Group II: PlaceboPlacebo Group2 Interventions

Placebo IV loading dose followed by SC, 24 weeks

0 / 12Eligibility 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 target various immune pathways to control the overactive immune system. Biologics like belimumab inhibit B-lymphocyte stimulator (BLyS) to reduce B cell activity and autoantibody production. Immunosuppressants such as azathioprine and mycophenolate mofetil limit immune cell proliferation, decreasing inflammation and autoimmunity. Corticosteroids like prednisone suppress the overall immune response to reduce inflammation. These mechanisms are vital for Lupus patients as they help manage disease activity and prevent organ damage.

[Neuropsychiatric Systemic Lupus Erythematosus].The 2018 pipeline of targeted therapies under clinical development for Systemic Lupus Erythematosus: a systematic review of trials.New Trials in Lupus and where Are we Going.