SAR441344 for Lupus

(APATURA Trial)

Recruiting in Palo Alto (17 mi)

+151 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

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

Trial Summary

What is the purpose of this trial?

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.

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.

What makes the drug SAR441344 unique for treating lupus?

SAR441344, also known as Frexalimab, is unique because it targets specific immune system components differently than other lupus treatments, potentially offering a novel approach to managing the disease. While other treatments like belimumab and anifrolumab focus on inhibiting B-cell activity or interferon pathways, SAR441344 may have a distinct mechanism of action, although specific details are not provided in the available research.

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Eligibility Criteria

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.

Trial Timeline

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

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Lone Start Arthritis & Rheumatology Associates Site Number : 8400025 Fort Worth, TX

SUNY Upstate Medical University-Site Number:8400006 Syracuse, NY

Arizona Arthritis & Rheumatology Associates Site Number : 8400027 Sun City, AZ

Saint John's Physician Partners Site Number : 8400015 Santa Monica, CA

More Trial Locations

Who Is Running the Clinical Trial?

Sanofi Lead Sponsor

References

1. England 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. [2022] Evaluate efficacy and safety of tabalumab, a human IgG4 monoclonal antibody that binds and neutralises membrane and soluble B-cell activating factor (BAFF) versus placebo plus standard of care (SoC) in patients with systemic lupus erythematosus (SLE).

2. England 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. [2022] To evaluate the effects of belimumab versus placebo, plus standard systemic lupus erythematosus (SLE) therapy, on organ domain-specific SLE disease activity.

3. New Zealand pubmed.ncbi.nlm.nih.gov

Efficacy and safety of biologic therapies for systemic lupus erythematosus treatment: systematic review and meta-analysis. [2022] The objectives of this study were to evaluate the efficacy, safety, and tolerability of biologic drugs compared with placebo for systemic lupus erythematosus (SLE) treatment.

4. England pubmed.ncbi.nlm.nih.gov

Characterisation of anifrolumab, a fully human anti-interferon receptor antagonist antibody for the treatment of systemic lupus erythematosus. [2022] We investigated the mechanistic and pharmacological properties of anifrolumab, a fully human, effector-null, anti-type I interferon (IFN) alpha receptor 1 (IFNAR1) monoclonal antibody in development for SLE.

5. England 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. [2017] To evaluate epratuzumab treatment in patients with moderately-to-severely active SLE in two international, randomized, controlled trials (ALLEVIATE-1 and -2) and an open-label extension study (SL0006).