EUCTR2020-003509-72-PL进行中（未招募）1 期
A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy
Amgen Inc.0 个研究点目标入组 320 人开始时间: 2021年5月11日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 320
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
- •101 Subject has provided informed consent prior to initiation of any
- •study specific activities/procedures.
- •102 Age = 18 years to 75 years at screening.
- •103 Fulfills classification criteria for SLE according to the 2019
- •EULAR)/ACR classification criteria for SLE (Aringer et al, 2019), with
- •antinuclear antibody = 1:80 by immunofluorescence on Hep-2 cells being present at screening. Anti--dsDNA results based on the Phadia method
- •will be used for SLE classification criteria and for the purposes of
- •hSLEDAI scoring during screening and throughout the study.
- •110 Hybrid SLEDAI score = 6 points with a Clinical hSLEDAI score = 4
- •points. The Clinical hSLEDAI is the hSLEDAI assessment score without
- •the inclusion of points attributable to laboratory results, including urine
- •and immunologic parameters. Including the following protocol specific
- •? Arthritis: for hSLEDAI scoring purposes, arthritis must involve small
- •joints in the hands or wrists.
- •? Alopecia: subjects should have hair loss without scarring; should
- •neither have alopecia areata nor androgenic alopecia; and should have a
- •CLASI activity score for alopecia ?
- •? Oral ulcers: ulcers location and appearance must be documented by
- •the investigator.
- •? Scleritis and episcleritis: the presence of stable SLE-related scleritis
- •and episcleritis (ie, that will likely not require initiation/increase in
- •immunosuppressants/immunomodulators as outlined in the
- •inclusion/exclusion criteria) must be documented by an ophthalmologist
- •and other causes excluded.
- •? Renal: subjects with urine protein/creatinine ratio < 2000 mg/g (or
- •equivalent) in a clean catch spot urine sample can enroll and be scored
- •in the hSLEDAI, provided the subject has a clinical hSLEDAI = 4.
- •? Pleurisy and Pericarditis: symptoms of pleurisy and pericarditis must
- •be accompanied by objective findings to be scored in the hSLEDAI.
- •105 BILAG index score (BILAG 2004) of = 1 A item or = 2 B items.
- •106 Must be taking = 1 of the following SLE treatments (or regional
- •equivalent):
- •hydroxychloroquine, chloroquine, quinacrine, mycophenolate mofetil,
- •azathioprine, methotrexate, dapsone, or oral calcineurin inhibitors, or
- •OCS. A subject may enter the study on OCS alone (prednisone = 10
- •mg/day or equivalent) only if the subject has previously documented
- •trial of anti-malarial or immunosuppressant treatment for SLE. Subjects
- •must be on a stable dose for = 8 weeks prior to screening for all
- •antimalarials and immunosuppressants, with the exception of OCS doses
- •which must be stable for = 2 weeks prior to
- •107 For subjects taking OCS, the dose must be = 20 mg/day of
- •prednisone or OCS
- •equivalent, and the dose must be stable for = 2 weeks prior to screening
- •Day 1 (Baseline):
- •The baseline/day 1 visit should occur after confirmation of eligibility by
- •the adjudication team within 33 days after the screening visit. At the
- •baseline/day 1 visit, the following 2 criteria should be assessed prior to
- •randomization:
- •108 Stability of SLE treatments: OCS and other
- •immunosuppressants/immunomodulator agents and doses must be
- 另有 9 项未显示
排除标准
- •231 Lupus nephritis if any of the following are present:
- •urine protein creatinine ratio = 2000 mg/g at screening, OR having
- •required induction therapy within 1 year prior to screening, OR
- •histological evidence of diffuse proliferative glomerulonephritis within 12 weeks prior to screening.
- •202 Active CNS lupus within 1 year prior to screening including, but not
- •limited to, aseptic meningitis, ataxia, CNS vasculitis, cranial neuropathy,
- •demyelinating syndrome, optic neuritis, psychosis, seizures, or
- •transverse myelitis.
- •232 Currently present or within 1 year prior to screening a diagnosis of
- •any chronic inflammatory disease other than SLE which would interfere
- •with SLE disease assessment.
- •204 History of any disease other than SLE that has required treatment
- •with oral or parenteral corticosteroids for > 2 weeks within 4 months
- •prior to screening.
- •205 Active infection for which anti-infectives were indicated within 4
- •weeks prior to screening visit OR presence of serious infection, defined
- •as requiring hospitalization or intravenous anti-infectives within 8 weeks
- •prior to screening visit.
- •206 Active tuberculosis or latent tuberculosis with no documented past
- •history of adequate treatment per local standard of care.
- •207 Positive test for tuberculosis during screening defined as: either a
- •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).
- •233 Positive for hepatitis B surface antigen (HBsAg); or positive for
- •hepatitis B core antibody (HBcAb). A history of hepatitis B vaccination
- •without history of hepatitis B infection, negative HBsAg and negative
- •HBcAb is allowed.
- •234 Positive for hepatitis C antibody
- •210 Known history of HIV or positive HIV test at screening.
- •235 Presence of 1 or more significant concurrent medical conditions,
- •including but not limited to the following: poorly controlled diabetes or
- •hypertension symptomatic heart failure myocardial infarction or
- •unstable angina pectoris within the past 12 months severe chronic
- •pulmonary disease requiring oxygen therapy multiple sclerosis or any
- •other demyelinating disease
- •212 Any history of malignancy with the following exceptions:
- •resolved non-melanoma skin cancers > 5 years prior to screening
- •resolved cervical carcinoma > 5 years prior to screening
- •resolved breast ductal carcinoma in situ > 5 years of screening
- •213 Currently receiving or had treatment with: cyclophosphamide,
- •chlorambucil, nitrogen mustard, or any other alkylating agent within 6
- •months prior to screening or sirolimus within 4 weeks prior to screening.
- •214 Currently receiving or had treatment with a JAK inhibitor within 3
- •months or less than 5 drug half-lives prior to screening.
- •215 Currently receiving or had treatment with an immune checkpoint
- •216 Currently receiving or had treatment within 12 months prior to
- •screening with T-cell depleting agents
- •217 Currently receiving or had treatment with an IL-2 based therapy
- •218 Current or previous treatment with a biologic agent as follows:
- 另有 7 项未显示
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