EUCTR2019-000328-16-PT进行中（未招募）1 期
A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Rozibafusp Alfa (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
- 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
- •- Subject has provided informed consent prior to initiation of any study specific activities/procedures.
- •- Age = 18 years to = 75 years at screening visit .
- •- Fulfills classification criteria for SLE according to the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE (Aringer et al, 2019), with antinuclear antibody = 1:80 by immunofluorescence on Hep-2 cells being present at screening.
- •- 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 or immunologic parameters.
- •Additional protocol-specific rules are applied at screening and throughout the study, as follows:
- •- Arthritis: Arthritis (at least 3 tender and swollen joints) must involve joints in the hands or wrists for the hSLEDAI scoring.
- •- 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 = 2.
- •- 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 < 3000 mg/g (or equivalent method) in a clear catch spot urine sample can enroll and be scored in the hSLEDAI, provided the subject has a clinical hSLEDAI = 4 and did not receive induction treatment for nephritis within the last year.
- •- Pleurisy and Pericarditis: symptoms of pleurisy and pericarditis must be accompanied by objective findings to be scored in the hSLEDAI.
- •- Unless there is a documented intolerance, subjects must be taking:
- •Only 1 of the following SLE treatments: anti malarial(hydroxychloroquine, chloroquine, or quinacrine), azathioprine, methotrexate, leflunomide, mycophenolate mofetil/acid mycophenolic, or dapsone.
- •2 of the above-mentioned SLE treatments in which 1 must be anti malarial (hydroxychloroquine, chloroquine, or quinacrine).
- •Treatment should be taken for = 12 weeks prior to screening and must be a stable dose for = 8 weeks prior to screening.
- •- For subjects taking OCS, dose must be = 20 mg/day of prednisone or OCS equivalent, and the dose must be stable at baseline visit for = 2 weeks prior to screening visit
- •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 295
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •-Urine protein creatinine ratio = 3000 mg/g (or equivalent) at screening or induction therapy for lupus nephritis within 1 year prior to screening visit.
- •-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.
- •-Diagnosis of any inflammatory joint or skin disease other than SLE (confirmed accurate by the PI) currently present or within 1 year prior to screening which would interfere with SLE disease assessment based on investigator judgment.
- •- Any disease other than SLE that has required treatment with oral or parenteral CS for > 2 weeks within 6 weeks prior to screening.
- •- Active infection OR infection for which anti-infectives were initiated within 4 weeks prior to screening OR presence of serious infection, defined as requiring hospitalization or IV anti-infectives within 8 weeks prior to screening.
- •-Active tuberculosis or latent tuberculosis with no documented past history of adequate treatment per local standard of care.
- •-Positive test for tuberculosis during screening defined as either positive or indeterminate QuantiFERON®-TB or T-spot test OR positive purified protein derivative (PPD).(see details in protocol).
- •-Positive for hepatitis B surface antigen (HBsAg); or positive for hepatitis B core antibody (HBcAb) in the presence of detectable viral DNA in peripheral blood. (see exception details in protocol).
- •- Positive for hepatitis C antibody in the presence of detectable viral ribonucleic acid (RNA) in peripheral blood, assessed by PCR. (see exception details in protocol).
- •- Known history of HIV or positive serology for HIV antibodies at screening.
- •- Presence of 1 or more significant concurrent medical conditions per investigator judgment (see details in protocol).
- •- 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 malignant colon polyps > 5 years prior to screening
- •- Currently receiving or had treatment with: cyclophosphamide, chlorambucil, nitrogen mustard, or any other alkylating agent within 6 months prior to screening; sirolimus or oral calcineurin inhibitors or thalidomide within 4 weeks prior screening.
- •- Currently receiving or had treatment with a Janus Kinase (JAK) inhibitor within 1month prior to screening.
- •- Currently receiving or had treatment with an immune checkpoint inhibitor.
- •- Current or previous treatment with a biologic agent with immunosuppressive/immunomodulatory activity for SLE or other conditions as follows: rituximab within 6 months prior to screening; abatacept, belimumab, and anifrolumab within the past 3 months prior to screening; other biologics within less than 5 drug half-lives or within the period of pharmacodynamic activity, when relevant, prior to screening.
- •- Subjects who have received intra-articular, intra-lesional, or systemic corticosteroid injections within 6 weeks prior to screening.
- •- Subjects who have received live vaccines within 5 weeks prior to screening, or plan to receive live vaccines during the treatment period and up to 16 weeks after the last administration of the investigational product.
- •- Currently receiving treatment in another investigational device or drug study.
- •- Ending a treatment with an investigational drug or investigational device less than 5 drug half-li
研究者
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