A Phase II, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of GDC-0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus

CompletadoFase 2ClinicalTrials.gov

ID: NCT02908100Tipo: INTERVENTIONALInicio: 19 de ene de 2017Fin estimado: 16 de jul de 2019

Traducción no disponible, mostrando original

Resumen

This is a study to evaluate the safety and efficacy of GDC-0853 in combination with standard of care therapy in participants with moderate to severe active systemic lupus erythematosus (SLE).

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Fulfillment of SLE classification criteria according to either American College of Rheumatology (ACR) or Systemic Lupus International Collaborating Clinics (SLICC) criteria at any time prior to or at screening
At least one serologic marker of SLE at screening as follows: positive antinuclear antibody (ANA) test by immunofluorescent assay with titer \>/= 1:80; or positive anti-double-stranded DNA (anti-dsDNA) antibodies; or positive anti-Smith antibody
At both screening and Day 1, moderate to severe active SLE, defined as meeting all of the following unless indicated otherwise: Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥ 8 (at screening only) with clinical SLEDAI-2K score \>/= 4.0 (at both screening and Day 1), Physician's Global Assessment \>/= 1.0 (out of 3), and currently receiving at least one standard oral treatment for SLE
If on oral corticosteroids (OCS), the dose must be \</= 40 mg/day prednisone (or equivalent)
Stable doses of anti-malarial or immunosuppressive therapies
Participants must be willing to avoid pregnancy

Criterios de exclusión

Proteinuria \> 3.5 g/24 h or equivalent using urine protein-to-creatinine ratio (uPCR) in a first morning void urine sample
Active proliferative lupus nephritis (as assessed by the investigator) or histological evidence of active Class III or Class IV lupus nephritis on renal biopsy performed in the 6 months prior to screening (or during the screening period)
History of having required hemodialysis or high dose corticosteroids (\>100 mg/d) prednisone or equivalent) for the management of lupus renal disease within 90 days of Day 1
Neuropsychiatric or central nervous system lupus manifestations
Serum creatinine \> 2.5 mg/dL, or estimated glomerular-filtration rate \< 30 milliliter per minute (mL/min) or on chronic renal replacement therapy
History of receiving a solid organ transplant
Evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis (TB)
Significant and uncontrolled medical disease within the 12 weeks prior to screening in any organ system (e.g., cardiac, neurologic, pulmonary, renal, hepatic, endocrine, metabolic, gastrointestinal, or psychiatric) not related to SLE, which, in the investigator's or Sponsor's opinion, would preclude study participation
History of cancer, including hematological malignancy and solid tumors, within 10 years of screening
Need for systemic anticoagulation with warfarin, other oral or injectable anticoagulants, or anti-platelet agents
Evidence of chronic and/or active hepatitis B or C

Intervenciones

drug

GDC-0853

Participants received GDC-0853 at dosages of 150 or 200mg as per the dosing schedules described above.

drug

Placebo

Participants received matching placebo to GDC-0853 at dosages of 150 and 200mg as per the dosing schedules described above.

Ubicaciones

Organizacion Medica de Investigacion

Buenos Aires, Argentina

APRILLUS

Buenos Aires, Argentina

Hospital Italiano de La Plata

La Plata, Argentina

CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica

San Juan, Argentina

Centro Medico Privado de Reumatologia; Reumathology

San Miguel, Argentina

Patrocinadores

PrincipalGenentech, Inc.

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