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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 70 Years
Gender	All

More 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05039840
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Sanofi
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Clinical Sciences & Operations
Principal Investigator Affiliation	Sanofi
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Argentina, Brazil, Chile, Georgia, Greece, Hungary, Italy, Mauritius, Mexico, Puerto Rico, Russia, Spain, Switzerland, Turkey (Türkiye), Ukraine, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Systemic Lupus Erythematosus
Study Website:	View Trial Website

Arms & Interventions

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

Drug: - SAR441344 IV

Pharmaceutical form: solution Route of administration: Intravenous infusion

Drug: - SAR441344 SC

Pharmaceutical form: solution Route of administration: subcutaneous injection

Drug: - Placebo IV

Pharmaceutical form: solution Route of administration: Intravenous infusion

Drug: - Placebo SC

Pharmaceutical form: solution Route of administration: subcutaneous injection

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Birmingham 4049979, Alabama 4829764

Status

Completed

Address

Achieve Clinical Research- Site Number : 8400003

Birmingham 4049979, Alabama 4829764, 35216

Site Contact

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