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A study to compare different doses of fenebrutinib with a “placebo” – in patients with lupus
Study of the Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus
- Transtorno Autoimune
- Lúpus Eritematoso Sistêmico
Observe que o status de recrutamento do estudo em seu centro pode ser diferente do status geral do estudo porque alguns centros de estudo podem recrutar mais cedo do que outros.
Status do estudo:
Concluído
Este estudo é realizado em
Cidades
- Espírito Santo
- Goiás
- Minas Gerais
- Paraná
- Rio Grande do Sul
- Santa Catarina
- São Paulo
Identificador de estudo:
NCT02908100 2016-001039-11 GA30044
Resumo do Estudo
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).
Genentech, Inc.
Patrocinador
Phase 2
Fase
NCT02908100,GA30044,2016-001039-11
Identificação do Estudo
All
Gênero
≥ 18 Years & ≤ 75 Years
Idade
No
Voluntários Saudáveis
Researchers wanted to find out what effect, good or bad, fenebrutinib caused in comparison to a placebo, in patients with systemic lupus erythematosus (lupus). A computer randomly decided which patients joined one of two fenebrutinib dose groups and which patients joined the placebo group. This was a double-blind study where patients and researchers did not know which of the 3 groups each patient belonged to.
Resumo do Estudo
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).
Genentech, Inc.
Patrocinador
Phase 2
Fase
NCT02908100,GA30044,2016-001039-11
Identificador de estudo
GDC-0853 (high dose), GDC-0853 (low dose), Placebo
Tratamento
Systemic Lupus Erythematosus
Condição
Título
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
Critérios de elegibilidade
Todos
Gênero
≥ 18 Anos & ≤ 75 Anos
Idade
Não
Voluntários Saudáveis
Critérios de Inclusão
- 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
Critérios de Exclusão
- 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
For the latest version of this information please go to www.forpatients.roche.com
