Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.
Inclusion Criteria:
Participants eligible for inclusion in this study must meet all of the following criteria:
- Adult male and female participants aged 18 years or older at the time of screening
- Weigh at least 35 kg at screening
- Have a confirmed clinical diagnosis of SLE according to European League Against
Rheumatism/American College of Rheumatology (EULAR/ACR) Systemic Lupus Erythematosus
(SLE) classification criteria
- Have a positive anti-nuclear antibody (ANA) test result; ANA titer ≥ 1:80 at screening
visit based on central or local laboratory result
- Active LN at screening, as defined by meeting the 3 following criteria:
- Renal biopsy within 6 months prior to screening period indicating ISN/RPS class III or
IV active glomerulonephritis with or without co-existing class V features, or pure
class V membranous LN. If no biopsy was performed within 6 months prior to screening
period, a biopsy will need to be performed during the screening period after having
met all other inclusion/exclusion criteria.
- UPCR ≥ 1.0 g/g on 24h urine collection at Screening
- eGFR ≥ 25mL/min/1.73 m2. Participants with eGFR < 30 mL/min/1.73 m2 require renal
biopsy during the screening period showing sclerosis in ≤ 50% of glomeruli
- Newly diagnosed participants as well as pre-treated LN participants (including
refractory cases) can be included, as long as they are currently on, or willing to
initiate SoC induction therapy for LN using MPA
- Induction therapy, as defined by treatment including both high dose
corticosteroids and MPA, should be initiated prior to or on day of randomization
- Anti-malarial treatment at stable dosing prior to randomization is strongly
recommended, in the absence of contraindications
- Participants on azathioprine treatment at Screening must be switched to MPA prior
to randomization
- Receipt of at least one dose of pulse methylprednisolone i.v. (250 - 1000 mg per day
up to 3000 mg cumulative dose) or equivalent for treatment of current episode of
active LN within 60 days prior randomization.
- Able to communicate well with the Investigator to understand and comply with the
requirements of the study
Exclusion Criteria:
Participants meeting any of the following criteria are not eligible for inclusion in this
study:
- Severe renal impairment as defined by i.) presence of oliguria (defined as a
documented urine volume < 400 mL/24 hrs) or ii.) End-Stage Renal Disease (ESRD)
requiring dialysis or transplantation
- Sclerosis in > 50% of glomeruli on renal biopsy
- Use of other investigational drugs within 5 half-lives of enrollment, or within 30
days or until the expected pharmacodynamic effect has returned to baseline
- Prior use of any B cell depleting therapy within 36 weeks prior to randomization or if
therapy was administered < 36 weeks prior to randomization B cell count less than the
lower limit of normal or patient's own baseline value prior to having received an
earlier B cell-depleting therapy
- Prior treatment with any of the following within 12 weeks prior to randomization
- Belimumab, telitacicept, abatacept, TNF-? mAb, immunoglobulins (i.v./s.c.)
plasmapheresis
- Any other immuno-suppressants (i.v. or oral cyclophosphamide, calcineurin
inhibitors, JAK inhibitors or other kinase inhibitors)
- Thalidomide treatment and/or one of the following DMARDs: methotrexate or an
imidazole derivative (e.g., mizoribine)
- Receipt of more than 3000 mg i.v. pulse methylprednisolone (cumulative dose) within 12
weeks prior to randomization
- History of major organ transplant or hematopoietic stem cell/bone marrow transplant or
are due to receive transplantation
- Any one of the following laboratory values at screening:
- Hemoglobin levels < 8.0 g/dL (< 5 mmol/L), or < 7.0 g/dL (< 4.3 mmol/L) if
related to participant's SLE such as in active hemolytic anaemia
- Platelet count < 25 x 1000/µL
- Absolute neutrophil count (ANC) < 0.8 x 1000/µL
- Active viral, bacterial or other infections requiring systemic treatment at the time
of screening, or history of recurrent clinically significant infection
- History of known intolerance/hypersensitivity to MPA, oral corticosteroids, or any
component of the study drug(s) or its excipients
- Receipt of live/attenuated vaccine within a 4-week period prior to randomization
- History of primary or secondary immunodeficiency, including a positive HIV test result
- History of malignancy of any organ system (other than localized basal cell carcinoma
or squamous cell carcinoma of the skin or or in-situ cervical cancer), treated or
untreated, within the past 5 years, regardless of whether there is evidence of local
recurrence or metastases
- Any surgical, medical (e.g., uncontrolled hypertension, heart failure or diabetes),
psychiatric or additional physical condition that the Investigator feels may
jeopardize the participants in case of participation in this study
- Chronic infection with hepatitis B (HBV) or hepatitis C (HCV). Positive serology for
hepatitis B surface antigen (HBsAg) excludes the participant
- Evidence of active tuberculosis (TB) infection (after anti-TB treatment, participants
with history of TB may become eligible according to national local guidelines)
- Pregnant or nursing (lactating) women
- Women of child-bearing potential, defined as all women physiologically capable of
becoming pregnant, unless they are using highly effective methods of contraception
during dosing and for 6 months after stopping of investigational medication
- Sexually active male participants, who do not agree to use barrier protection during
intercourse with women of child-bearing potential while taking study treatment
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 6/27/23. Questions regarding updates should be directed to the study team contact.