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Not recruiting
Phase 2

Frexalimab

Sponsor:

Sanofi

Code:

NCT05039840

Conditions

Systemic Lupus Erythematosus

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

SAR441344 IV

SAR441344 SC

Placebo IV

Placebo SC

Study Details

Brief summary:

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

Conditions

Systemic Lupus Erythematosus

Study ID

NCT05039840

Start date

Nov 10, 2021

Status verified date

Mar, 2026

Completion date

Oct 2, 2026

Anticipated

Primary completion date

Jul 10, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

116 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Frexalimab

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

placebo comparator: Placebo

Placebo IV loading dose followed by SC, 24 weeks

Interventions

SAR441344 IV

Pharmaceutical form: solution Route of administration: Intravenous infusion

SAR441344 SC

Pharmaceutical form: solution Route of administration: subcutaneous injection

Placebo IV

Pharmaceutical form: solution Route of administration: Intravenous infusion

Placebo SC

Pharmaceutical form: solution Route of administration: subcutaneous injection

Primary outcome measure

  • Percentage of participants who achieved a Systemic Lupus Erythematosus Responder Index (SRI-4) response at Week 24. [ Time Frame: At Week 24 ]

Central Contacts and Locations

Central contacts

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

800-633-1610contact-us@sanofi.com

Locations

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Chandler- Site Number : 8400026

Recruiting

Chandler, Arizona, United States, 85225

Arizona Arthritis & Rheumatology Associates - South Vineyard Avenue- Site Number : 8400022

Recruiting

Mesa, Arizona, United States, 85210

Arizona Arthritis & Rheumatology Research - Sun City- Site Number : 8400027

Recruiting

Sun City, Arizona, United States, 85351

AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Tucson Southeast- Site Number : 8400023

Recruiting

Tucson, Arizona, United States, 85748

Saint John's Physician Partners- Site Number : 8400015

Recruiting

Santa Monica, California, United States, 90404

More Information

Sponsor

Sanofi

Last update posted

Mar 20, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Sanofi on 2026-03-20. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.