EUCTR2019-000328-16-DE进行中（未招募）1 期
A Phase 2 Dose Ranging Study to Evaluate the Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy - Safety and Efficacy of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE)
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
- 300
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
入选标准
- •- Subject has provided informed consent prior to initiation of any study-specific activities/procedures.
- •- Age = 18 years to = 75 years at visit 1.
- •- Fulfills classification criteria for SLE according to the SLICC criteria or by at least 4 of the 11 criteria of the 1997 modification of the ACR classification criteria for SLE, with at least 1 of the following being present at screening: Antinuclear antibody = 1:80; or Elevated anti-dsDNA antibodies by the Farr assay.
- •- SLEDAI-2K score = 6 points with Clinical SLEDAI-2K score = 4 points. The Clinical SLEDAI-2K is the SLEDAI-2K assessment score without the inclusion of points attributable to any urine or laboratory results including immunologic measures. For a subject whose clinical SLEDAI-2K score requires any of the following components, the subject must meet the following additional criteria:
- •o Arthritis: 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 in the hands or wrists, and the distribution should not involve the ankles, elbows, shoulders, or hips.
- •o Alopecia: Subjects scoring for alopecia on the SLEDAI-2K should have patchy hair loss without scarring; subjects should neither have alopecia areata nor androgenic alopecia.
- •o Oral ulcers: Subjects scoring for oral ulcers on the SLEDAI-2K should have physician documented location and appearance.
- •o Rash: To contribute to the minimally required clinical SLEDAI-2K score, rash must have been present for a minimum of 1 week, must cover at least 5% of the body surface area if discoid and 10% of the body surface area if any other type of lupus rash. Rash must have physician documented location and appearance.
- •- Must be taking at least 1 but not more than 2 of the following SLE treatments: mycophenolate mofetil, azathioprine, methotrexate, hydroxychloroquine, chloroquine, dapsone, or quinacrine. Treatment should be taken for =12 weeks prior to screening and must be a stable dose for = 8 weeks prior to screening. Patients cannot be taking two immunosuppresants (ie, mycophenolate mofetil, azathioprine, or methotrexate) simultaneously.
- •- For subjects taking OCS, dose must be = 20 mg/day of prednisone or OCS equivalent, and the dose must be stable = 4 weeks prior to screening.
- •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 280
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •- History of lupus nephritis requiring induction therapy within 1 year or active lupus nephritis (defined as any of the following: clean catch, spot urine protein creatinine ratio > 3000 mg/g at screening or active urinary sediment attributable to SLE).
- •- History of CNS lupus within 1 year prior to screening or active CNS lupus including, but not limited to, aseptic meningitis, ataxia, CNS vasculitis, cranial neuropathy, demyelinating syndrome, optic neuritis, psychosis, seizures, or transverse myelitis.
- •- Currently present or within 1 year prior to screening a diagnosis of any inflammatory joint or skin disease other than SLE (confirmed accurate by the PI) which would interfere with SLE disease assessment based on investigator judgement.
- •- History of any disease other than SLE that has required treatment with oral or parenteral corticosteroids for > 2 weeks within 6 months 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 or indeterminate QuantiFERON®-TB or T-spot test OR positive purified protein derivative (PPD) (= 5 mm of induration at 48 to 72 hours after test is placed).
- •- Positive for hepatitis B surface antigen, hepatitis B core antibody (confirmed by hepatitis B DNA polymerase chain reaction [PCR] test) or detectable hepatitis C virus RNA by PCR (screening is generally done by hepatitis C antibody [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 allowed.
- •- Known history of HIV or positive serology for HIV antibodies at screening.
- •- Presence of 1 or more significant concurrent medical conditions per investigator judgment, including but not limited to the following:
- •o poorly controlled diabetes or hypertension (ie, systolic blood pressure > 170 mmHg and/or diastolic blood pressure > 100 mmHg)
- •o symptomatic heart failure (New York Heart Association class III or IV)
- •o myocardial infarction or unstable angina pectoris within the past 12 months prior to randomization
- •o severe chronic pulmonary disease (eg, requiring oxygen therapy)
- •o multiple sclerosis or any other demyelinating disease
- •o major chronic inflammatory disease or connective tissue disease other than SLE (eg, RA, mixed connective tissue disease [MCTD], antiphospholipid antibody syndrome)
- •- Currently receiving or had treatment with: cyclophosphamide, chlorambucil, nitrogen mustard, or any other alkylating agent = 6 months prior to day 1 OR oral calcineurin inhibitors (eg, cyclosporine, tacrolimus, sirolimus, voclosporin) = 4 weeks prior to day 1.
- •- Currently receiving or had treatment with a JAK inhibitor or oral, targeted investigational agent (eg, Bruton’s tyrosine kinase inhibitor) < 3 months or 5 half-lives (whichever is longer) prior to day 1.
- •- Prior treatment with an immune checkpoint inhibitor (eg, PD-1 i
研究者
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