M2951 is an investigational drug under evaluation for treatment of autoimmune and inflammatory disorders. The purpose of the study was to assess the Safety and Efficacy of M2951 in participants with Systemic Lupus Erythematosus (SLE).

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Eligible male and female participants, aged 18 to 75 years
Must have diagnosis of SLE with either the Systemic Lupus International Collaborating Clinics (SLICC) criteria for SLE, or at least four of the 11 American College of Rheumatology (ACR) classification criteria for SLE, of at least six months duration prior to Screening
SLEDAI-2K total score greater than or equal to (\>=) 6 (including clinical SLEDAI greater than or equal to (\>=) 4) at Screening Visit
And be positive for anti-double-stranded Deoxyribonucleic Acid (DNA) and/or anti-nuclear antibody (ANA greater than or equal to (\>=) 1:80) and/or anti-Smith (anti-Sm) antibody at the time of Screening

Criterios de exclusión

Participants are not eligible for this study if they have active, clinically significant interstitial lung disease or pulmonary arterial hypertension
Proteinuria (urine protein to creatinine ratio \[UPCR\] \> 4 mg/mg)
Acutely worsened renal function
Central nervous system SLE
Or within two weeks prior to Screening or during Screening: use of oral corticosteroids greater than (\>) 30 mg daily prednisone equivalent
Use of injectable corticosteroids, or change in dose of corticosteroids.

Intervenciones

drug

Placebo

Participants received placebo matched to M2951 orally for 52 weeks.

drug

M2951

Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.

drug

M2951

Participants received 75 mg of M2951 orally QD for 52 weeks.

drug

M2951

Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.

drug

M2951

Participants who had received Placebo or M2951 (25 mg QD, 75 mg QD or 50 mg BID) during DBPC period were switched to receive 50 mg M2951 orally BID in LTE period for 104 weeks.

Ubicaciones

Instituto de Investigaciones Clinicas

Mar del Plata, Buenos Aires, Argentina

Instituto de Investigaciones Clinicas Quilmes

Quilmes, Buenos Aires, Argentina

Centro Integral de Reumatologia

San Miguel de Tucumán, Tucumán Province, Argentina

Centro Medico Privado de Reumatologia

San Miguel de Tucumán, Tucumán Province, Argentina