SAR441344 for Lupus

(APATURA Trial)

Recruiting at 159 trial locations

Overseen By Trial Transparency email recommended (Toll free number for US & Canada)

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sanofi

Must be taking: Standard of care

Must not be taking: Cyclophosphamide, High-dose steroids

Disqualifiers: Severe lupus nephritis, Neuropsychiatric SLE, Thromboembolic events, Serious infections, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 12

Duration: 24 weeks

116 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called SAR441344 for individuals with active Systemic Lupus Erythematosus (SLE). The goal is to determine if this drug manages symptoms more effectively than a placebo (a look-alike treatment with no active drug). Participants will receive either the experimental drug or a placebo for 24 weeks. Individuals who have had SLE for at least six months and experience symptoms like joint pain or skin rash might be suitable candidates. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it mentions that participants should not have high doses or recent changes in steroids, antimalarials, or immunosuppressants. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that SAR441344, also known as Frexalimab, is generally well-tolerated by patients. Earlier studies reported no serious side effects that would raise major safety concerns. This suggests the treatment might be safe for humans, although some mild side effects like headaches or mild nausea have been noted, which are common with many medications. As a Phase 2 trial, it aims to further assess the treatment's safety, indicating it has already passed initial safety tests in earlier research phases. Safety data are still being collected, but the treatment's progress through multiple trial phases suggests it is likely safe for most people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for lupus?

Frexalimab is unique because it targets a specific protein in the immune system called CD40L, which plays a key role in lupus inflammation. Unlike traditional treatments like corticosteroids and immunosuppressants that broadly dampen the immune response, Frexalimab offers a more precise approach by blocking this single protein, potentially reducing side effects. Additionally, Frexalimab is initially administered intravenously for quick action, followed by subcutaneous doses for convenience, which could improve patient adherence to treatment. Researchers are excited about its potential to provide a more targeted and effective therapy for lupus with fewer side effects.

What evidence suggests that SAR441344 might be an effective treatment for Lupus?

In this trial, participants will receive either Frexalimab, also known as SAR441344, or a placebo. Research has shown that Frexalimab might help treat active Systemic Lupus Erythematosus (SLE). This treatment targets specific proteins in the immune system believed to be involved in SLE. Early findings suggest that Frexalimab can reduce symptoms and inflammation linked to lupus, potentially managing flare-ups and improving the quality of life for people with SLE. Further studies are underway to confirm these initial results. ^{1 2 3 4 6}

Who Is on the Research Team?

Clinical Sciences & Operations

Principal Investigator

Sanofi

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am currently on a standard treatment for lupus.

I have been diagnosed with lupus for at least 6 months.

My weight is between 45 kg and 120 kg.

Exclusion Criteria

I have had serious infections like histoplasmosis or candidiasis.

I do not have active or untreated latent tuberculosis.

I do not have a serious infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Frexalimab or placebo for 24 weeks with visits every 2 weeks

24 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

8-10 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• SAR441344

Trial Overview 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.

How Is the Trial Designed?

Group I: Frexalimab Experimental Treatment 2 Interventions

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

Group II: Placebo Placebo Group 2 Interventions

Placebo IV loading dose followed by SC, 24 weeks

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Published Research Related to This Trial

Belimumab was found to be more effective than placebo in treating systemic lupus erythematosus (SLE), showing improvements in various disease activity measures, while rituximab did not demonstrate superior efficacy over placebo.

Both belimumab and rituximab exhibited satisfactory safety profiles, with no significant differences in adverse events compared to placebo, suggesting that biologic agents are promising options for SLE treatment and warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of biologic therapies for systemic lupus erythematosus treatment: systematic review and meta-analysis. Borba, HH., Wiens, A., de Souza, TT., et al.[2022]

Anifrolumab effectively reduces the surface expression of the type I interferon alpha receptor (IFNAR1) on human monocytes, leading to decreased activation of the type I interferon signaling pathway, which is crucial in systemic lupus erythematosus (SLE).

The drug inhibits the production of type I interferon and its associated inflammatory responses without exhibiting cytotoxic effects, making it a promising therapeutic option for SLE and other conditions characterized by abnormal type I interferon signaling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterisation of anifrolumab, a fully human anti-interferon receptor antagonist antibody for the treatment of systemic lupus erythematosus. Riggs, JM., Hanna, RN., Rajan, B., et al.[2022]

Epratuzumab treatment showed promising efficacy in patients with moderately-to-severely active systemic lupus erythematosus (SLE), with a response rate of 44.1% at week 12 for the 360 mg/m² dose compared to 30.0% for placebo, although the trials were prematurely discontinued due to drug supply issues.

The safety profile of epratuzumab was comparable to placebo, with no new safety concerns identified during the study, supporting its potential as a treatment option for SLE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of epratuzumab in patients with moderate/severe flaring systemic lupus erythematosus: results from two randomized, double-blind, placebo-controlled, multicentre studies (ALLEVIATE) and follow-up. Wallace, DJ., Gordon, C., Strand, V., et al.[2017]

In a phase III study involving 1164 patients with moderate-to-severe systemic lupus erythematosus (SLE), tabalumab did not show a statistically significant improvement in the primary endpoint of achieving SLE Responder Index 5 (SRI-5) response compared to placebo, with response rates of 31.8% and 29.3% respectively at week 52.

Tabalumab demonstrated biological activity by reducing anti-dsDNA antibodies and total B cells, but its safety profile was similar to that of the placebo, with no significant differences in serious adverse events or mortality rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of subcutaneous tabalumab in patients with systemic lupus erythematosus: results from ILLUMINATE-1, a 52-week, phase III, multicentre, randomised, double-blind, placebo-controlled study. Isenberg, DA., Petri, M., Kalunian, K., et al.[2022]

In a study involving 1684 autoantibody-positive patients over 52 weeks, belimumab significantly improved disease activity in key organ domains of systemic lupus erythematosus (SLE), particularly in musculoskeletal and mucocutaneous areas.

Patients receiving belimumab experienced less worsening in haematological, immunological, and renal domains compared to those on placebo, indicating its potential to enhance overall disease management in SLE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of belimumab, a B lymphocyte stimulator-specific inhibitor, on disease activity across multiple organ domains in patients with systemic lupus erythematosus: combined results from two phase III trials. Manzi, S., Sánchez-Guerrero, J., Merrill, JT., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05039840

Study Details | NCT05039840 | Efficacy and Safety of ... This is a multinational, randomized, placebo-controlled, parallel treatment, Phase 2, double-blind, 2 arm study evaluating the efficacy and safety of SAR441344

2. sanofistudies.com sanofistudies.com/cwout/CW-V9DEXS//it/it/listing/286331/efficacy-and-safety-of/

Efficacy and Safety of Frexalimab (SAR441344) in the ... This is a multinational, randomized, placebo-controlled, parallel treatment, Phase 2, double-blind, 2 arm study evaluating the efficacy and safety of SAR441344

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05039840/efficacy-and-safety-of-frexalimab-sar441344-in-the-treatment-of-systemic-lupus-erythematosus

Efficacy and Safety of Frexalimab (SAR441344) in the ... This is a multinational, randomized, placebo-controlled, parallel treatment, Phase 2, double-blind, 2 arm study evaluating the efficacy and safety of SAR441344

4. clinicaltrials.eu clinicaltrials.eu/trial/study-on-frexalimab-for-treating-active-systemic-lupus-erythematosus-in-patients/

Study on Frexalimab for Treating Active Systemic Lupus ... This clinical trial is focused on studying the effectiveness and safety of a treatment called Frexalimab (also known by its code name SAR441344)

5. sperimentazionicliniche.it sperimentazionicliniche.it/sito2021clinicmap/component/clinicmap/clinicmaps?single=NCT05039840

Efficacy and Safety of Frexalimab (SAR441344) in the ... This is a multinational, randomized, placebo-controlled, parallel treatment, Phase 2, double-blind, 2 arm study evaluating the efficacy and safety of SAR441344

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05039840?tab=history&a=34

Record History | NCT05039840 A general description of the clinical trial arm. It identifies the role of the intervention that participants receive. Types of arms include ...