Efficacy and Safety of Frexalimab (SAR441344) in the Treatment of Systemic Lupus Erythematosus
Launched by SANOFI · Sep 1, 2021
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment called Frexalimab (SAR441344) for adults aged 18 to 70 who have an active condition known as Systemic Lupus Erythematosus (SLE). The trial will compare Frexalimab to a placebo (a dummy treatment with no active ingredient) to see how well it works and how safe it is for patients. Participants will be involved in the study for a total of 36 weeks, with the treatment period lasting 24 weeks and visits scheduled every two weeks.
To take part in this trial, individuals must have been diagnosed with SLE for at least six months and meet certain health criteria, such as having specific blood test results and disease symptoms. However, people with certain other health issues, like severe kidney problems or infections, cannot participate. If eligible, participants will receive careful monitoring and support throughout the study, helping researchers learn more about this potential new treatment for SLE.
Gender
ALL
Eligibility 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.
About Sanofi
Sanofi is a global healthcare leader dedicated to empowering life through innovation in pharmaceuticals and vaccines. With a strong commitment to research and development, Sanofi focuses on addressing complex health challenges across various therapeutic areas, including diabetes, oncology, immunology, and rare diseases. The company leverages advanced science and technology to develop transformative therapies that improve patient outcomes. Through collaborative partnerships and a patient-centric approach, Sanofi strives to enhance global health and deliver sustainable solutions that meet the evolving needs of healthcare systems and communities worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Milano, , Italy
Monterrey, Nuevo León, Mexico
Gyula, , Hungary
Monterrey, , Mexico
Sao Paulo, São Paulo, Brazil
Heraklion, , Greece
San Miguel De Tucuman, Tucumán, Argentina
Santiago, Reg Metropolitana De Santiago, Chile
Osorno, Los Lagos, Chile
Madrid, Madrid, Comunidad De, Spain
Roma, Lazio, Italy
Caba, Buenos Aires, Argentina
Santiago, Reg Metropolitana De Santiago, Chile
Birmingham, Alabama, United States
Thousand Oaks, California, United States
Debary, Florida, United States
Austin, Texas, United States
Talca, Maule, Chile
Moscow, , Russian Federation
Moscow, , Russian Federation
Kyiv, , Ukraine
Caba, Buenos Aires, Argentina
Birmingham, Alabama, United States
Thousand Oaks, California, United States
Debary, Florida, United States
Memphis, Tennessee, United States
Austin, Texas, United States
Houston, Texas, United States
Berazategui, Buenos Aires, Argentina
Caba, Buenos Aires, Argentina
Buenos Aires, , Argentina
San Miguel De Tucuman, , Argentina
Athens, , Greece
Athens, , Greece
Thassaloniki, , Greece
Benito Juarez, , Mexico
Yucatan, , Mexico
Moscow, , Russian Federation
Moscow, , Russian Federation
Moscow, , Russian Federation
Ryazan, , Russian Federation
Saint Petersburg, , Russian Federation
Barcelona, , Spain
Ankara, , Turkey
Denizli, , Turkey
Kyiv, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Poltava, , Ukraine
Vinnytsia, , Ukraine
Napoli, , Italy
Quatre Bornes, , Mauritius
Mexico, , Mexico
Barcelona / Sabadell, Catalunya [Cataluña], Spain
Syracuse, New York, United States
Curitiba, Paraná, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Sao Paulo, São Paulo, Brazil
São José Do Rio Preto, São Paulo, Brazil
Thessaloníki, , Greece
Székesfehérvár, , Hungary
\\Ciudad De México, Ciudad De Mexico, Mexico
Firenze, , Italy
Chihuahua, , Mexico
Veracruz, , Mexico
New York, New York, United States
Sao Paulo, São Paulo, Brazil
Heraklion, , Greece
Madrid, Madrid, Comunidad De, Spain
Santiago, Reg Metropolitana De Santiago, Chile
Roma, Lazio, Italy
Buenos Aires, , Argentina
Birmingham, Alabama, United States
Thousand Oaks, California, United States
Debary, Florida, United States
New York, New York, United States
Oklahoma City, Oklahoma, United States
Memphis, Tennessee, United States
Austin, Texas, United States
Houston, Texas, United States
Berazategui, Buenos Aires, Argentina
Caba, Buenos Aires, Argentina
Caba, Buenos Aires, Argentina
Caba, Buenos Aires, Argentina
San Miguel De Tucuman, , Argentina
Curitiba, Paraná, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Sao Jose Do Rio Preto, São Paulo, Brazil
Sao Paulo, São Paulo, Brazil
Osorno, Los Lagos, Chile
Talca, Maule, Chile
Santiago, Reg Metropolitana De Santiago, Chile
Athens, , Greece
Athens, , Greece
Larissa, , Greece
Thassaloniki, , Greece
Gyula, , Hungary
Székesfehérvár, , Hungary
Firenze, , Italy
Milano, , Italy
Napoli, , Italy
Quatre Bornes, , Mauritius
\\Ciudad De México, Ciudad De Mexico, Mexico
México, D.F., México, Mexico
Monterrey, Nuevo León, Mexico
Benito Juarez, , Mexico
Chihuahua, , Mexico
Chihuahua, , Mexico
Mexico, , Mexico
Veracruz, , Mexico
Yucatan, , Mexico
Moscow, , Russian Federation
Barcelona / Sabadell, Castilla Y León, Spain
Ankara, , Turkey
Denizli, , Turkey
Kyiv, , Ukraine
Kyiv, , Ukraine
Poltava, , Ukraine
Benito Juárez, Ciudad De Mexico, Mexico
Benito Juarez, Ciudad De México, Mexico
Kyiv, , Ukraine
Kyiv, , Ukraine
San Juan, , Puerto Rico
Ankara, , Turkey
Ciudad Autonoma Bs As, , Argentina
Sanford, Florida, United States
St. Gallen, , Switzerland
Simi Valley, California, United States
Lubbock, Texas, United States
Fort Worth, Texas, United States
Irving, Texas, United States
Colleyville, Texas, United States
Chandler, Arizona, United States
Mesa, Arizona, United States
Tucson, Arizona, United States
Plantation, Florida, United States
West Long Branch, New Jersey, United States
Sun City, Arizona, United States
Santa Monica, California, United States
Santa Fe, New Mexico, United States
New York, New York, United States
Tbilisi, , Georgia
Tbilisi, , Georgia
Tbilisi, , Georgia
Napoli, Campania, Italy
Roma, Lazio, Italy
Milan, Lombardia, Italy
San Miguel De Tucuman, , Argentina
Birmingham, Alabama, United States
Chandler, Arizona, United States
Mesa, Arizona, United States
Sun City, Arizona, United States
Tucson, Arizona, United States
Santa Monica, California, United States
Simi Valley, California, United States
Debary, Florida, United States
Plantation, Florida, United States
Sanford, Florida, United States
West Long Branch, New Jersey, United States
Santa Fe, New Mexico, United States
New York, New York, United States
Oklahoma City, Oklahoma, United States
Memphis, Tennessee, United States
Austin, Texas, United States
Colleyville, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Irving, Texas, United States
Lubbock, Texas, United States
Caba, , Argentina
Curitiba, Paraná, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Sao Jose Do Rio Preto, São Paulo, Brazil
Sao Paulo, São Paulo, Brazil
Sao Paulo, São Paulo, Brazil
Talca, Maule, Chile
Tbilisi, , Georgia
Mexico, Ciudad De Mexico, Mexico
San Juan, , Puerto Rico
Thessaloniki, , Greece
Athens, , Greece
Sabadell, Castilla Y León, Spain
Birmingham, Alabama, United States
Chandler, Arizona, United States
Mesa, Arizona, United States
Sun City, Arizona, United States
Debary, Florida, United States
Plantation, Florida, United States
New York, New York, United States
Memphis, Tennessee, United States
Austin, Texas, United States
Colleyville, Texas, United States
Lubbock, Texas, United States
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
San Miguel De Tucumán, , Argentina
Curitiba, Paraná, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
São José Do Rio Preto, São Paulo, Brazil
São Paulo, , Brazil
São Paulo, , Brazil
Santiago, Reg Metropolitana De Santiago, Chile
Tbilisi, , Georgia
Tbilisi, , Georgia
Athens, , Greece
Heraklion, , Greece
Larissa, , Greece
Vacoas Phoenix, , Mauritius
Mexico City, Ciudad De Mexico, Mexico
Chihuahua, , Mexico
Mexico City, , Mexico
Mérida, , Mexico
San Juan, , Puerto Rico
Ankara, , Turkey
Oklahoma City, Oklahoma, United States
Napoli, Campania, Italy
Chihuahua, , Mexico
Valladolid, , Spain
Tucson, Arizona, United States
Simi Valley, California, United States
Irving, Texas, United States
Berazategui, Buenos Aires, Argentina
Mexico City, Ciudad De Mexico, Mexico
Valencia, , Spain
West Long Branch, New Jersey, United States
Caserta, Campania, Italy
Valladolid, , Spain
New York, New York, United States
San Miguel De Tucumán, Tucumán, Argentina
Milan, Milano, Italy
Caserta, , Italy
Roma, , Italy
Mérida, Yucatán, Mexico
Madrid, , Spain
Monterrey, , Mexico
Curitiba, , Brazil
São José Do Rio Preto, , Brazil
Sabadell, , Spain
Naples, Napoli, Italy
Veracruz, , Mexico
Patients applied
Trial Officials
Clinical Sciences & Operations
Study Director
Sanofi
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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