A Phase 3, Randomized, Double-blind, Multicenter, Placebo Controlled Study of Inebilizumab Efficacy and Safety in IgG4-Related Disease
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Amgen
- 入组人数
- 135
- 试验地点
- 7
- 主要终点
- RCP: Time to Disease Flare
研究概览
简要总结
This study aims to evaluate the efficacy and safety of inebilizumab for the prevention of flare of Immunoglobulin G4-related disease (IgG4-RD).
详细描述
After a screening period of up to 28 days, subjects with IgG4-RD at high risk of flare due to multi-organ disease and recent active disease will be randomized in a 1:1 ratio to receive intravenous (IV) inebilizumab or placebo after premedication during the 52-week randomized control period (RCP). All subjects will receive an initial tapering dose of glucocorticoids (GCs) to complete treatment of their active disease. Flares occurring during study will be treated. The primary endpoint is time to a first adjudication committee-determined, investigator-treated disease flare during the RCP. The primary analysis will be conducted when the last subject completes the RCP visit or discontinues the RCP. This study includes an optional 3-year open-label treatment period. The study also includes a Safety Follow-up Period (SFUP) of up to 730 days for all participants. The expected duration of each subject's participation in this study is up to 400 days (screening and RCP), plus up to 1095 days for eligible subjects who enroll in the optional open label period (OLP), and up to 730 days for the SFUP, for a total maximum duration of up to 2273 days (screening, RCP, interval between RCP and OLP, OLP, and FSUP).
Study acquired from Horizon in 2024.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female adults, ≥ 18 years of age at time of informed consent.
- •Clinical diagnosis of IgG4-RD.
- •Fulfillment of the 2019 ACR/EULAR classification criteria.
- •Experiencing (or recently experienced) an IgG4-RD flare that requires initiation or continuation of glucocorticoid (GC) treatment at the time of informed consent.
- •IgG4-RD affecting at least 2 organs/sites at any time in the course of IgG4-RD
- •Non-sterilized male subjects who are sexually active with a female partner of childbearing potential must use a condom with spermicide from Day 1 through to the end of the study and must agree to continue using such precautions for at least 6 months after the final dose of IP. Females of childbearing potential who are sexually active with a non-sterilized male partner must use a highly effective method of contraception
排除标准
- •History of solid organ or cell-based transplantation or known immunodeficiency disorder.
- •Active malignancy or history of malignancy that was active within the last 10 years (some specific situations for cervical, skin or prostate cancer are acceptable).
- •Receipt of any biologic B cell-depleting therapy or non-depleting B-cell-directed therapy in the 6 months prior to screening.
- •Receipt of non-biologic DMARD or immunosuppressive agent other than GCs within 4 weeks prior to screening.
- •Active tuberculosis or high risk for tuberculosis; hepatitis C infection in absence of curative treatment; evidence of hepatitis B infection.
- •Receipt of live vaccine or live therapeutic infectious agent within 2 weeks prior to screening.
- •Estimated glomerular filtration rate < 30 mL/min/1.73 m^2.
研究组 & 干预措施
VIB0551
Inebilizumab administered as an IV infusion.
干预措施: Inebilizumab (Drug)
Placebo
Placebo administered as an IV infusion.
干预措施: Placebo (Other)
结局指标
主要结局
RCP: Time to Disease Flare
时间窗: Up to Week 52
Time to disease flare was defined as the number of days from Day 1 (dosing) to the date of the first treated and Adjudication Committee (AC)-determined IgG4-RD flare within the 52-week RCP. The date of disease flare was determined by the initiation of any flare treatment, including new or increased glucocorticoid (GC) treatment, other immunotherapy, or an interventional procedure, as deemed necessary by the Investigator to address the flare. Kaplan-Meier (KM) method was used to estimate the median time to flare, and 95% confidence interval (CI).
次要结局
- RCP: Annualized Rate of Treated and AC-Determined Flares During the RCP(Week 52)
- RCP: Percentage of Participants Achieving Flare-free, Treatment-free Complete Remission at Week 52(Week 52)
- RCP: Percentage of Participants Achieving Flare-free, Corticosteroid-free Complete Remission at Week 52(Week 52)
- Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) During the RCP(Up to Week 52)
- Number of Participants Who Experienced TEAEs During the OLP(From the first dose of investigational product in OLP to the end of OLP or cutoff date; median (min, max) duration was 51.6 (0.1, 108.3) weeks.)
- RCP: Number of Participants With Anti-drug Antibodies (ADA) to Inebilizumab by Week 52(Baseline to Week 52)
- RCP: Time to Initiation of First Treatment for New or Worsening Disease Activity Within the RCP(Week 52)
- RCP: Annualized Flare Rate for AC-Determined IgG4-RD Flares at Week 52(Week 52)
- RCP: Cumulative Glucocorticoid (GC) Use for IgG4-RD Disease Control by Week 52(Week 52)