Efficacy and Safety of Frexalimab (SAR441344) in the Treatment of Systemic Lupus Erythematosus

Research Study for Systemic Lupus Erythematosus

Recruiting
18 years - 70 years
All
Phase 2
116 participants needed
5 Locations

Study Overview

This is a multinational, randomized, placebo-controlled, parallel treatment, Phase 2, double-blind, 2 arm study evaluating the efficacy and safety of SAR441344 in comparison with placebo in the treatment of participants aged 18 to 70 years with active Systemic Lupus Erythematosus (SLE). Study details include:

  • Study duration: 36 weeks
  • Treatment duration: 24 weeks
  • Visit frequency: every 2 weeks

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Systemic Lupus Erythematosus
  • Age: 18 years - 70 years
  • Gender: All

Inclusion Criteria:

  • 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
  • Positive antinuclear antibody (ANA) (titer ≥1:80) during screening
  • Positivity for at least one serological characteristic
  • Total hSELENA-SLEDAI score ≥6 (including points attributed from arthritis and rash) during screening and at least 4 points from clinical features at randomization as confirmed by a Sponsor-selected independent reviewer(s)
  • At least 1 BILAG A score or 2 BILAG B scores during screening as confirmed by a Sponsor-selected independent reviewer(s)
  • Receiving at least one of the standard of care (SOC) for SLE (combination is possible)
  • Body weight within 45 kg to 120 kg (inclusive) at screening
  • Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria:

  • Primary diagnosis of a rheumatic disease besides SLE or an inflammatory joint or skin disease other than SLE that could confound the disease activity assessments
  • Active and severe lupus nephritis
  • Active severe or unstable neuropsychiatric SLE including but not limited to seizures, psychosis, acute confusional state, transverse myelitis, central nervous system vasculitis and optic neuritis
  • Known or suspected drug-induced lupus
  • History, clinical evidence, suspicion or significant risk, for thromboembolic events, as well as myocardial infarction, stroke, and/or antiphospholipid syndrome and any participants requiring antithrombotic treatment
  • History or current hypogammaglobulinemia
  • Serious systemic viral, bacterial or fungal infection
  • Participants with a history of invasive opportunistic infections, such as, but not limited to histoplasmosis, listeriosis, coccidioidomycosis, candidiasis, pneumocystis jirovecii, and aspergillosis, regardless of resolution
  • Evidence of active or untreated latent tuberculosis as documented by medical history (eg, chest Xrays) and examination, and tuberculosis testing
  • High dose of steroids, or a change in dose within 4 weeks prior to randomization
  • High dose of antimalarial, or a change in dose within 12 weeks prior to randomization
  • High dose of immunosuppressants or a change in dose within 12 weeks prior to randomization
  • Use of cyclophosphamide within 3 months prior to screening
  • Previous parenteral (IV), intramuscular (IM), or intra-articular steroid administration within 4 weeks prior to randomization
  • Participants likely to require multiple courses of oral corticosteroid (OCS) during the study for chronic diseases other than SLE
  • Administration of any live (attenuated) vaccine within 3 months prior to randomization (eg, varicella zoster vaccine, oral polio, rabies)
  • Administration of any non-live vaccine (eg, seasonal influenza, COVID-19) within 4 weeks prior to randomization

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Updated on 31 Jan 2025. Study ID: NCT05039840

This study investigates an investigational medication for adults aged 18 to 70 with active Systemic Lupus Erythematosus (SLE). SLE is a chronic autoimmune disease where the immune system attacks its own tissues, causing inflammation and damage. The study compares the investigational medication with a placebo to evaluate its safety and effectiveness.

Participants will be randomly assigned to one of two study arms. One arm will receive the investigational medication, and the other will receive a placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine. The study is double-blind, meaning neither the participants nor the researchers will know who is receiving the investigational medication or the placebo.

  • Who can participate: Adults aged 18 to 70 with a confirmed diagnosis of Systemic Lupus Erythematosus (SLE) for at least 6 months can participate. Key eligibility includes a positive antinuclear antibody test and specific clinical scores. Participants must be on standard SLE treatments and meet weight criteria.
  • Study details: Participants will be randomly assigned to receive either the investigational medication or a placebo. The study is double-blind, meaning neither participants nor researchers will know who receives which treatment.
  • Study Timelines and Visits: The study will last 36 weeks. The study requires 18 visits.

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What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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