NCT04948099已完成1 期
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of VIB1116 in Conventional Dendritic Cell (cDC) and Plasmacytoid Dendritic Cell (pDC)-Mediated Rheumatic Diseases
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 73
- 试验地点
- 11
- 主要终点
- Treatment-emergent adverse events, treatment-emergent serious adverse events, and adverse events of special interest
研究概览
简要总结
A first-in-human study to evaluate the safety and tolerability of escalating, single and multiple ascending doses of VIB1116 in adult participants with rheumatic diseases.
详细描述
Study acquired from Horizon in 2024. Originally Viela Bio was the sponsor.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 18 years of age and ≤ 60 years of age and a body mass index (BMI) < 30 kg/m² or, in patients who have completed dosing with a vaccine against COVID-19 and are at least 1 month post the last dose, ≤ 65 years of age and BMI < 35 kg/m^2
- •A diagnosis of one of a specified list of rheumatologic diseases at least 6 months prior to screening.
- •Stable dosing (or no use) of glucocorticoid or disease-modifying antirheumatic drugs (DMARDs) used for treatment of rheumatologic disease for ≥ 28 days prior to randomization.
- •Willing to practice study-required contraception.
排除标准
- •Planning to change treatment for rheumatologic disorder within 4 months after randomization
- •Known immunodeficiency disorder or history of splenectomy, organ or cell-based transplantation, total lymphoid irradiation or T-cell vaccination or transfusion in prior 6 months
- •Treatment with prednisone or equivalent at a dose > 10 mg/day or intraarticular, intravenous or intramuscular steroids within 28 days prior to screening
- •Treatment with any of the following medications within 28 days prior to screening (unless otherwise specified below) above the given doses:
- •Mycophenolate mofetil > 2 g/day
- •Methotrexate > 20 mg/week
- •Leflunomide > 20 mg/day within 6 months prior to screening or receipt of leflunomide in combination with any dose of methotrexate
- •Azathioprine > 2 mg/kg/day
- •Cyclosporine (except eye drops); tacrolimus (except topical), sirolimus, thalidomide, lenalidomide, 6-mercaptopurine, or voclosporin
- •Hydroxychloroquine > 400 mg/day
- •Chloroquine > 250 mg/day
- •Quinacrine > 100 mg/day
- •Sulfasalazine > 3 g/day, except that no more than 1 g/day is permitted if used in combination with methotrexate
- •Dapsone > 100 mg/day
- •Danazol > 800 mg/day
- •Any other nonbiologic immunosuppressive/immunomodulatory agent not already specified (eg, mizoribine, retinoids, adrenocorticotropic hormone analogs, dehydroepiandrosterone [DHEA]) within 2 weeks prior to screening.
- •Receipt of any biologic B cell-depleting therapy within 12 months or non-depleting B cell-directed therapy within 6 months
- •Receipt of abatacept, etanercept, or other biologic immunomodulatory agent or immunoglobulins within 3 months
- •Receipt of any other biologic disease modifying antirheumatic drug (bDMARD) not already specified, such as any targeted therapy (other than Janus kinase [JAK] inhibitor), or receipt of cyclophosphamide or chlorambucil within 6 months
- •Receipt of JAK inhibitors within 3 months
- •Receipt of anticoagulants other than anti-platelet drugs in prior 28 days
- •Active malignancy, history of malignancy within prior 10 years (limited exceptions) or known first degree relative with a hereditary cancer syndrome unless the patient is known to be free of the predisposing genetic mutation
- •Receipt of live vaccine or live therapeutic infectious agent within the 28 days prior to screening.
- •Pregnancy, lactation, or planning to become pregnant or donate/retrieve eggs before the end of study follow-up.
- •Hepatitis B or C infection, HIV infection, evidence of active TB or being at high risk for TB
- •History of any severe herpes virus infection (including any history of severe Epstein-Barr virus, cytomegalovirus disease, end-organ disease, disseminated herpes simplex, disseminated zoster, or ophthalmic zoster) or > 1 episode of herpes zoster in the 2 years prior to screening and/or any opportunistic infection in the prior 2 years
- •Infection requiring parenteral antimicrobial therapy within 60 days of screening or any clinically significant active or suspected infection ( within 28 days prior to screening
- •History of anaphylaxis to any human immunoglobulin therapy or monoclonal antibody.
- •Blood tests at screening (performed in the central laboratory) that meet study requirements including but not limited to normal coagulation testing and glomerular filtration rate < 50 mL/min/1.73
- •High risk for COVID-19 or for severe COVID-19
研究组 & 干预措施
VIB1116
Experimental
Single dose of VIB1116, SC or IV administration.
Multiple doses of VIB1116, SC administration.
干预措施: VIB1116 (Drug)
Placebo
Placebo Comparator
Single dose of Placebo, SC or IV administration.
Multiple doses of Placebo, SC administration.
干预措施: Placebo (Drug)
结局指标
主要结局
Treatment-emergent adverse events, treatment-emergent serious adverse events, and adverse events of special interest
时间窗: Up to Day 141
次要结局
- Serum concentration of VIB1116 and noncompartmental PK parameters(Up to Day 141)
- Percentage of Participants who are ADA (antidrug antibody) positive(Up to Day 141)
- Titer in ADA positive participants(Up to Day 141)
- Change from baseline in the blood levels of plasmacytoid dendritic cells(Up to Day 141)
研究者
研究点 (11)
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