Estudio de fase III, aleatorizado, doble ciego, controlad... | EligiMed

Estudio de fase III, aleatorizado, doble ciego, controlado con placebo y multicéntrico para evaluar la eficacia y la seguridad de obinutuzumab en pacientes con lupus eritematoso sistémico

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT04963296Tipo: INTERVENTIONALInicio: 26 de oct de 2021Fin estimado: 14 de mar de 2028

Resumen

Este estudio de grupos paralelos, doble ciego y controlado con placebo evaluará la eficacia y la seguridad de obinutuzumab versus placebo en participantes con lupus eritematoso sistémico (LES) activo positivo para autoanticuerpos que reciben tratamiento estándar.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) Classification Criteria \>=12 weeks prior to screening
Anti-nuclear antibody (ANA) \>=1:80, or anti-dsDNA and/or anti-Sm antibodies above the upper limit of normal (ULN), as determined by the central laboratory at screening
Low C3 or low C4 or low CH50 complement as determined by the central laboratory at screening
High disease activity at screening, based on; BILAG-2004 (Category A disease in \>=1 organ system and/or Category B disease in \>=2 organ systems), Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) (score \>=8) and Physician's Global Assessment (PGA) (score \>=1.0 on a 0 to 3 visual analogue scale \[VAS\])
High disease activity on Day 1, based on; SLEDAI-2K (score \>=8) and PGA (score \>=1.0 on a 0 to 3 VAS)
Current receipt of \>=1 of the following classes of standard therapies for the treatment of SLE at stable doses: oral corticosteroid (OCS), antimalarials, conventional immunosuppressants
The Medical Monitor may be consulted if there are any questions related to eligibility criteria

Criterios de exclusión

Pregnancy or breastfeeding
Presence of significant lupus-associated renal disease and/or renal impairment
Receipt of an excluded therapy, including any anti-CD20, anti-CD19 therapy less than 9 months prior to screening or during screening; or cyclophosphamide, tacrolimus, ciclosporin, or voclosporin during the 2 months prior to screening or during screening
Significant or uncontrolled medical disease which, in the investigator's opinion, would preclude patient participation
Known active infection of any kind or recent major episode of infection
Intolerance or contraindication to study therapies

Intervenciones

drug

Obinutuzumab

Obinutuzumab will be administered by IV infusion at a dose of 1000 mg on Day 1 and at Weeks 2, 24 and 26.

drug

Placebo

Placebo matching obinutuzumab will be administered by IV on Day 1 and at Weeks 2, 24 and 26.

drug

Acetaminophen/Paracetamol

Acetaminophen 650-1000 mg will be administered as premedication prior to infusions.

drug

Diphenhydramine hydrochloride

Diphenhydramine 50 mg will be administered as premedication prior to infusions.

drug

Methylprednisolone

Methylprednisolone 80 mg IV will be administered as premedication prior to infusions.

Ubicaciones

Organizacion Medica de Investigacion

Buenos Aires, Argentina

DOM Centro de Reumatología

Buenos Aires, Argentina

Centro de Investigaciones Médicas Tucuman

San Miguel, Argentina

Patrocinadores

PrincipalHoffmann-La Roche

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