Last updated 15 days ago
Efficacy and Safety of Frexalimab (SAR441344) in the Treatment of Systemic Lupus Erythematosus
116 patients around the world
Available in Argentina, Chile, United States
Sanofi
7Research sites
116Patients around the world
This study is for people with
Lupus
Systemic lupus erythematosus
Requirements for the patient
To 70 Years
All Gender
Medical requirements
- 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 criteriaPositive antinuclear antibody (ANA) (titer ≥1:80) during screeningPositivity for at least one serological characteristicTotal 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 screeningContraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Primary diagnosis of a rheumatic disease besides SLE or an inflammatory joint or skin disease other than SLE that could confound the disease activity assessmentsActive and severe lupus nephritisActive severe or unstable neuropsychiatric SLE including but not limited to seizures, psychosis, acute confusional state, transverse myelitis, central nervous system vasculitis and optic neuritisKnown or suspected drug-induced lupusHistory, clinical evidence, suspicion or significant risk, for thromboembolic events, as well as myocardial infarction, stroke, and/or antiphospholipid syndrome and any participants requiring antithrombotic treatmentHistory or current hypogammaglobulinemiaSerious systemic viral, bacterial or fungal infectionParticipants with a history of invasive opportunistic infections, such as, but not limited to histoplasmosis, listeriosis, coccidioidomycosis, candidiasis, pneumocystis jirovecii, and aspergillosis, regardless of resolutionEvidence of active or untreated latent tuberculosis as documented by medical history (eg, chest Xrays) and examination, and tuberculosis testingHigh dose of steroids, or a change in dose within 4 weeks prior to randomizationHigh dose of antimalarial, or a change in dose within 12 weeks prior to randomizationHigh dose of immunosuppressants or a change in dose within 12 weeks prior to randomizationUse of cyclophosphamide within 3 months prior to screeningPrevious parenteral (IV), intramuscular (IM), or intra-articular steroid administration within 4 weeks prior to randomizationParticipants likely to require multiple courses of oral corticosteroid (OCS) during the study for chronic diseases other than SLEAdministration 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
Sites
Sala de Primeros Auxilios Alberto Mignaburu - Berazategui, Prov Buenos Aires
Recruiting
Clínica Adventista Belgrano - CABA - Buenos Aires
Recruiting
DOM Centro de Reumatología - CABA
Recruiting
STAT Research - CABA
Centro de Investigaciones Médicas Tucumán
Recruiting
Fundación CIDEA - Buenos Aires
Centro Paulista de Investigação Clínica - CEPIC
Recruiting
StudyAPATURA
SponsorSanofi
Study typeInterventional
Conditions
Systemic lupus erythematosus
Requirements
To 70 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05039840
