EUCTR2020-004047-86-PL进行中（未招募）1 期
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ALPN-101 IN SYSTEMIC LUPUS ERYTHEMATOSUS
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 130
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
- •Males and females, age 18 through 70 years, inclusive, at Screening
- •Diagnosis of lupus for = 6 months prior to Screening
- •Positive ANA and/or elevated anti-dsDNA and/or elevated anti-Smith antibody test at Screening
- •Active SLE as defined at Screening as confirmed by Sponsor or
- •designee, and at Baseline (i.e., prior to randomization on Day 1) as
- •confirmed by Investigator
- •Stable, appropriate standard of care for SLE
- •List of extended Inclusion Criteria changes only below. Please see
- •protocol for full list:
- •1. Males and females, age 18 through 70 years, inclusive, at Screening.
- •3. Subjects must have a positive anti-nuclear antibodies (ANA) (titer =
- •1:80) and/or elevated anti-dsDNA and/or elevated anti-Smith antibody
- •test (if the screening test(s) are negative [based on central or local
- •testing], then an historic positive serology for ANA, elevated anti-dsDNA,
- •and/or elevated anti-Smith antibody test, with unequivocal
- •documentation, may be accepted).
- •7. Subjects must be on appropriate SOC (i.e., at least one anti-malarial
- •or an immunosuppressant) for SLE, based on the Investigator's
- •judgement. If taking the following medications, the subject must be on a
- •stable dose prior to Baseline (i.e., Day 1 prior to randomization) for the
- •period of time specified below, and must intend to continue at stable
- •doses throughout the 24-week
- •Treatment Period, unless otherwise specified by this protocol:
- •8. Willing to provide consent for serial photographic documentation of
- •any cutaneous manifestations of SLE, and/or oral mucocutaneous
- •lesions (including aphthous ulcers) not attributed to SLE, from Screening
- •through the EoS.
- •11. Should be up-to-date on all age-appropriate vaccinations, including
- •COVID-19, per local and professional guidelines for
- •immunocompromised individuals (e.g., CDC, local professional society
- •guidelines).
- •12. Peripheral venous access anticipated to be adequate to tolerate
- •planned dosing regimen of IV infusions and blood draws Q2W per Table 1
- •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 130
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Life-threatening or organ system-threatening SLE activity, that is
- •sufficiently active that it is expected to require increase in treatment
- •during the study
- •Proteinuria consistent with nephrotic syndrome: = 3.5 g
- •proteinuria/day, estimated based on urine protein-creatinine ratio
- •(UPCR) = 350 mg/mmol at Screening
- •Active lupus-related neuropsychiatric disease (with the exceptions of
- •mild stable lupus headache, fatigue, mild stable organic brain syndrome)
- •Drug-induced lupus
- •Evidence of active infection or risk or history of serious infection with
- •tuberculosis; hepatitis B, hepatitis C; HIV
- •Evidence of active infection with SARS-CoV-2
- •List of extended Inclusion Criteria changes only below. Please see
- •protocol for full list:
- •5. h. Current or recent (within the past 12 months) history of alcoholism
- •or significant drug abuse (recreational use of cannabis is not an
- •exclusion criterion).
- •6. a. Active or latent TB (refer to §6.7 for specific requirements for TB
- •screening). Subjects with a history of latent TB are allowed with
- •documentation of completed treatment with a regimen recommended by
- •an appropriate local or national health authority (e.g., CDC).
- •b. Hepatitis B virus: serologic evidence of hepatitis B infection based on
- •the results of testing for hepatitis B surface antigen (HBsAg), hepatitis B
- •core antibody (HBcAb), and hepatitis B
- •surface antibody (HBsAb) as follows:
- •i. Subjects positive for HBsAg are excluded.
- •ii. Subjects negative for HBsAg but positive for HBcAb, regardless of
- •HBsAb status will be excluded.
- •c. Hepatitis C virus (HCV): HCV RNA detectable in any subject with
- •positive HCV antibody.
- •d. Seropositivity for HIV at Screening.
- •e. Positive reverse transcription polymerase chain reaction (RT-PCR) test
- •for SARS-CoV-2 at Screening.
- •f. History of progressive multifocal leukoencephalopathy.
- •g. Receipt of oral or parenteral anti-infectives (antibacterials, antivirals,
- •antifungals, or antiparasitic agents) for infection, = 2 weeks prior to Day
- •1 (NOTE: chronic oral antibiotics
- •used for prophylaxis may be permitted, dependent on discussion with,
- •and agreement of, the Medical Monitor).
- •14. Functional class IV as defined by the ACR 1991 Revised Criteria for the Classification of Global Functional Status in Rheumatoid Arthritis.
- •e. Biologic therapies, including but not limited to: atacicept, telitacicept,
- •belimumab, abatacept, belatacept, anifrolumab, inhibitors of interleukin
- •(IL) pathways IL-6, IL-12/23, IL-17, IL-1, tumor necrosis factor a, or
- •interferon a: 12 weeks (exception: the use of prophylactic COVID-19
- •monoclonal antibodies in immunocompromised subjects is encouraged
- •as per Principal Investigator's discretion and local guidelines).
- •j. Combination therapy with = 2 immunosuppressants for the treatment
- •of SLE: A discussion with, and agreement by, the Medical Monitor and
- •Sponsor will be required.
- •18. Known hypersensitivity to ALPN-101, components thereof, or
- 另有 5 项未显示
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