EUCTR2017-002564-40-DE进行中（未招募）1 期
A Phase 1b/2a Study to Evaluate the Safety and Efficacy of AMG 592 in Subjects With Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Amgen Inc
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Subject has provided informed consent prior to initiation of any study specific activities/procedures.
- •- Age = 18 years to 60 years at screening.
- •- Fulfils diagnostic criteria for SLE according to the Systemic Lupus International
- •Collaborating Clinics (SLICC) criteria or by at least 4 of the 11 criteria of the 1997
- •American College of Rheumatology (ACR) classification criteria for SLE, with at
- •least one of the following being present at screening:
- •? Antinuclear antibody 1:80; or
- •? Elevated anti-dsDNA antibodies
- •- Phase 2a Subjects Only: At least one of the following at screening:
- •? SLEDAI 2K 6 without including anti-dsDNA or C3 and C4 complement
- •toward the total score. If a subject qualifies for the study by scoring for
- •arthritis on the SLEDAI 2K form, they must have 3 swollen and/or tender
- •joints; or CLASI score 10
- •- Phase 2a Subjects Only: Meets SLE diagnostic and severity requirements per
- •Central Review team at screening
- •- Phase 2a Subjects Only: Taking at least 1 but not more than 3 of the following
- •SLE treatments: mycophenolate mofetil, azathioprine, methotrexate,
- •hydroxychloroquine, chloroquine, dapsone (confirmed by blood specific drug
- •levels) or quinacrine. Subjects must be on SLE treatment for = 12 weeks and
- •have a stable dose for 4 weeks prior to day 1.
- •- Phase 1b Subjects only: May be taking = 3 systemic SLE treatments and the
- •dose must be stable for = 4 weeks prior to day 1.
- •- Prednisone dose = 20 mg daily (or other equivalent oral corticosteroid) with
- •stable dose = 2 weeks prior to day 1
- •- Phase 1b Subjects Only: Normal or clinically acceptable ECG values (12-lead
- •reporting ventricular rate and PR, QRS, QT and QTc interval) at screening and
- •baseline based on opinion of the investigator.
- •- Immunizations (tetanus, diphtheria, pertussis [Td/Tdap]), seasonal influenza
- •(during flu season), and pneumococcal (polysaccharide) vaccinations] up to date
- •per local standards as determined by the investigator
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 42
排除标准
- •cerebritis 1 year prior to screening
- •- Phase 2a only: Spot urine protein to creatinine ratio > 2 mg/g at
- •- Diagnosis of inflammatory joint or skin disease other than SLE which
- •would interfere with SLE disease assessment based on investigator
- •- Diagnosis of fibromyalgia which would interfere with SLE assessment
- •- Prosthetic joint infection within 3 years of screening or native joint
- •infection within 1 year prior to screening.
- •- Active infection (including chronic or localized infections) for which
- •anti-infectives were indicated within 4 weeks prior to day 1 OR presence
- •of serious infection, defined as requiring hospitalization or intravenous
- •anti-infectives within 8 weeks prior to day 1.
- •- Known history of active tuberculosis
- •- Positive test for tuberculosis during screening defined as either:
- •positive purified protein derivative (PPD) (= 5 mm of induration at 48 to
- •2 hours after test is placed) OR positive Quantiferon test o a positive
- •PPD and a history of Bacillus Calmette-Guérin vaccination are allowed
- •with a negative Quantiferon test and negative chest X-ray o a positive
- •PPD test (without a history of Bacillus Calmette-Guérin vaccination) or a
- •positive or indeterminate Quantiferon test are allowed if they have ALL
- •of the following at screening:
- •no symptoms per tuberculosis worksheet provided by Amgen,
- •documented history of a completed course of adequate prophylaxis
- •(completed treatment for latent tuberculosis per local standard of care
- •prior to the start of investigational product), no known exposure to a
- •case of active tuberculosis after most recent prophylaxis, negative chest
- •- Positive for hepatitis B surface antigen, hepatitis B core antibody or
- •detectable hepatitis C virus RNA by PCR [HepCAb], followed by hepatitis
- •C virus RNA by PCR if HepCAb is positive). A
- •history of hepatitis B vaccination without history of hepatitis B is
- •- Phase 1b Subjects Only: Positive for Human Immunodeficiency Virus
- •(HIV) at screening, or known to be HIV positive
- •Phase 2a Subjects Only: Known history of HIV
- •- Presence of one or more significant concurrent medical conditions per
- •investigator judgment, including but not limited to the following:
- •poorly controlled diabetes or hypertension
- •chronic kidney disease stage IIIb, IV, or V
- •symptomatic heart failure myocardial infarction or unstable angina
- •pectoris within the past 12 months
- •prior to randomization
- •severe chronic pulmonary disease (eg, requiring oxygen therapy)
- •multiple sclerosis or any other demyelinating disease
- •major chronic inflammatory disease or connective tissue disease other
- •than SLE (eg, RA)
- •- Malignancy except non-melanoma skin cancers, cervical or breast
- •ductal carcinoma in situ within 5 years of screening
- •- History of alcohol or substance abuse within 6 months of screening
- •- Phase 1b Subjects Only: Current smoker, and/or use of any nicotine or
- •tobacco containing products within the last 6 months prior to day 1.
- •These types of products include but are not limited to: snuff, chewing
- •tobacco, cigars, cigarettes, electronic cigarettes, pipes, or nicotine
- 另有 6 项未显示
研究者
相似试验
进行中（未招募）
1 期
Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid ArthritisMedDRA version: 20.0Level: HLTClassification code 10039075Term: Rheumatoid arthritis and associated conditionsSystem Organ Class: 100000004870Rheumatoid ArthritisEUCTR2017-001944-36-BGAmgen Inc153
进行中（未招募）
1 期
Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid ArthritisMedDRA version: 20.0Level: HLTClassification code 10039075Term: Rheumatoid arthritis and associated conditionsSystem Organ Class: 100000004870Rheumatoid ArthritisEUCTR2017-001944-36-PLAmgen Inc153
进行中（未招募）
1 期
Safety and Efficacy of AMG 592 in Subjects with Active Rheumatoid ArthritisMedDRA version: 20.0Level: HLTClassification code 10039075Term: Rheumatoid arthritis and associated conditionsSystem Organ Class: 100000004870Rheumatoid ArthritisEUCTR2017-001944-36-ESAmgen Inc36
进行中（未招募）
1 期
A Phase 1B/2 Study To Evaluate The Safety And Efficacy of PF-04449913, An Oral Hedgehog Inhibitor, In Combination With Intensive Chemotherapy, Low Dose ARA-C Or Decitabine In Patients With Acute Myeloid Leukemia Or High-Risk Myelodysplastic SyndromeEUCTR2012-000684-24-ITPfizer Inc. 235 East 42nd Street, New York, NY 10017255
进行中（未招募）
1 期
A Study To Evaluate PF-04449913 With Chemotherapy In Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome.Acute myeloid leukemia or myelodysplastic syndromeMedDRA version: 16.0 Level: LLT Classification code 10000886 Term: Acute myeloid leukemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 16.0 Level: PT Classification code 10028533 Term: Myelodysplastic syndrome System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2012-000684-24-ESPfizer Inc. 235 East 42nd Street, New York, NY 10017255