Home › Trials › NCT05039840

Evaluating Frexalimab for treating Systemic Lupus Erythematosus

Efficacy and Safety of SAR441344 in the Treatment of Systemic Lupus Erythematosus: A Randomized, Double Blind, Placebo-controlled, Phase 2, Proof of Concept Study

Phase 2 Interventional Sanofi · NCT05039840

This study is testing if a new treatment called Frexalimab can help people with active Systemic Lupus Erythematosus feel better compared to a placebo.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment116 (estimated)
Ages18 Years to 70 Years
SexAll
SponsorSanofi Industry-sponsored
Drugs / interventionscyclophosphamide
Locations71 sites (Birmingham, Alabama and 70 other locations)
Trial IDNCT05039840 on ClinicalTrials.gov

What this trial studies

This clinical trial is a multinational, randomized, placebo-controlled, double-blind study assessing the efficacy and safety of Frexalimab (SAR441344) in patients aged 18 to 70 with active Systemic Lupus Erythematosus (SLE). Participants will be treated for 24 weeks with either Frexalimab or a placebo, with visits scheduled every two weeks over a total study duration of 36 weeks. The study aims to determine how well Frexalimab works compared to a placebo in managing SLE symptoms.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with a confirmed diagnosis of active Systemic Lupus Erythematosus.

Not a fit: Patients with mild SLE or those not meeting the specific inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from Systemic Lupus Erythematosus.

How similar studies have performed: Other studies have shown promise in similar approaches for treating SLE, but the specific efficacy of Frexalimab is being evaluated for the first time in this context.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Birmingham, Alabama and 70 other locations

+21 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Systemic Lupus Erythematosus
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.