A Phase 1b, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Imvotamab in Participants With Moderate to Severe Rheumatoid Arthritis Who Have Failed Prior Therapies
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 33
- 试验地点
- 17
- 主要终点
- To evaluate the safety and tolerability of imvotamab in participants with moderate to severe rheumatoid arthritis
研究概览
简要总结
The purpose of this study is to determine the safety and tolerability of imvotamab in patients with moderate to severe rheumatoid arthritis who have failed prior therapies.
Participants will be given imvotamab or placebo through a vein (i.e., intravenously). A placebo is a look-alike substance that contains no active drug
详细描述
This is a Phase 1b, randomized, placebo-controlled, multicenter study to determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of imvotamab in adult participants with active RA who are refractory or intolerant to 2 previous biologic disease-modifying anti-rheumatic drugs (bDMARD) or targeted synthetic disease-modifying anti-rheumatic drugs (tsDMARD) therapies. Approximately 40 participants will be sequentially assigned to different dose escalation cohorts.
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, Investigator)
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
- •Age ≥ 18 years at the time of signing ICF
- •Documented diagnosis of RA and meeting the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for RA at least 1 year prior to screening
- •Have had treatment with bDMARDs and/or tsDMARD and were refractory by 1 of 2 reasons:
- •Lack of benefit to at least 2 bDMARDs in different mechanism classes or 1 bDMARD and 1 tsDMARD, after at least 12 weeks of treatment, in the opinion of the investigator. Lack of benefit may include inadequate improvement in joint counts, physical function, or disease activity.
- •Intolerance to at least 2 bDMARDs in different mechanism classes or 1 bDMARD and 1 tsDMARD.
- •Minimum of 6 swollen (SJC) and 6 tender joints (TJC) on a 66/68 joint count at the screening and baseline visit (SJC/TJC)
- •Central lab results for hsCRP ≥ 0.8 mg/dL
- •Anti-citrullinated protein antibodies (ACPA) positive and/or rheumatoid factor (RF) positive
- •If using oral corticosteroids (OCS), must be on a stable dose equivalent to ≤ 10 mg/day of prednisone for at least 2 weeks prior to first study treatment
排除标准
- •History of a rheumatologic autoimmune disease other than RA (except secondary Sjögren's syndrome), or with significant systemic involvement secondary to RA (vasculitis, pulmonary fibrosis, or Felty's syndrome); Juvenile idiopathic arthritis (JIA) or idiopathic arthritis diagnosed before the age of 16 years; Psoriatic Arthritis; Axial spondylarthritis or any other disease associated with inflammatory arthritis; Active fibromyalgia with pain symptoms or signs that would interfere with clinical assessments for RA
- •Receipt of an investigational therapy less than 3 months or 5 drug-elimination half-lives (whichever is longer) prior to first administration of study treatment and during the study
- •Receipt of any of the following excluded RA therapies:
- •Any cell depleting therapy, anti-CD4, anti-CD5, anti-CD3, rituximab, ocrelizumab, or ofatumumab, less than 6 months prior to first administration of study treatment.
- •Have received prior tsDMARds including but not limited to inhibitors of Janus kinase (JAK), Bruton tyrosine kinase, or tyrosine kinase 2, including baricitinib, tofacitinib, upadacitinib, filgotinib, ibrutinib, or fenebrutinib, or any investigational agent less than 3 months or 5 half-lives, whichever is longer, prior to first administration of study treatment
- •Have received prior immunomodulatory bDMARDs for RA including, but not limited to adalimumab, golimumab, ustekinumab, secukinumab, tocilizumab, abatacept, or other inhibitors of TNF, IL-6, IL-23, or IL-17 less than 3 months or 5 half-lives, whichever is longer, prior to first administration of the study treatment
- •Requiring therapy with prednisone > 10 mg/day (or equivalent dose) within 2 weeks prior to first study treatment
研究组 & 干预措施
Imvotamab (Dose Escalation)
Imvotatmab administered intravenously
干预措施: Imvotamab (Drug)
PBO IV
Placebo administered intravenously
干预措施: Placebo (Drug)
结局指标
主要结局
To evaluate the safety and tolerability of imvotamab in participants with moderate to severe rheumatoid arthritis
时间窗: Up to Week 52
Incidence of adverse events (AEs), serious adverse events (SAEs), including serious infectious events (SIEs) and opportunistic infections (OIs)
次要结局
未报告次要终点