2023-503910-60-00已完成2 期
A Phase 2 Randomized, Double-blind, Placebo-controlled, Dose-ranging, Efficacy and Safety study of SAR441566 plus Methotrexate in Adults with Moderate to Severe Rheumatoid Arthritis
Sanofi-Aventis Recherche & Developpement30 个研究点 分布在 6 个国家目标入组 194 人开始时间: 2024年3月14日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 194
- 试验地点
- 30
- 主要终点
- Proportion of participants achieving at least 20% improvement from baseline in the American College of Rheumatology (ACR) score at week 12
研究概览
简要总结
To demonstrate that SAR441566, a small molecule specific inhibitor of TNFR1 signaling compared to placebo, plus methotrexate (MTX), is effective in the treatment of moderate-to-severe rheumatoid arthritis (RA) with regards to American College of Rheumatology 20 (ACR20)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of adult-onset RA classified by ACR/EULAR 2010 revised classification criteria for RA of at least 3 months duration, with the onset of signs and symptoms of RA of at least 6 months duration
- •Moderate-to-severely active RA, defined as: • persistently active disease >= 6 tender and >= 6 swollen joints • high sensitivity C-reactive protein ≥4 mg/L
- •Continuous treatment with MTX for at least 12 consecutive weeks prior to randomization and with stable dose/means of administration at least 6 weeks prior to the screening visit. • MTX – 10 to 25 mg/week (or per local labeling requirements for the treatment of RA if the dose range differs) and folic/folinic acid (as part of MTX regimen).
- •Inadequate clinical response to MTX at a dose of 10-25 mg/week after proper dose escalation according to local standards .
- •BMI within the range [18 – 35] kg/m2 (inclusive)
排除标准
- •Immunologic disorder other than RA, with the exception of secondary Sjogren's syndrome associated with RA, and medically controlled diabetes or thyroid disorder as per Investigator's judgement.
- •Use of parenteral glucocorticoids or intra-articular glucocorticoids within 4 weeks prior to screening.
- •Initiation or change in dose for nonsteroidal anti-inflammatory drugs (NSAIDs) within 1 week prior to screening.
- •Any condition (other than RA) requiring oral, intravenous, IM, or intra-articular glucocorticoid therapy.
- •Uncontrolled polymyalgia rheumatica or fibromyalgia.
- •History of recurrent or recent serious infection (eg, pneumonia, septicemia) or infection(s) requiring hospitalization or treatment with IV anti-infectives (antibiotics, antivirals, antifungals, antihelminthics) within 30 days prior to D
- •Infections(s) requiring oral anti-infectives (antibiotics, antivirals, antifungals, antihelminthics) within 14 days prior to D
- •Known history of or suspected significant current immunosuppression, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
- •History of moderate-to-severe congestive heart failure (NYHA Class III or IV), recent cerebrovascular accident, or any other condition in the opinion of the Investigator that would put the participant at risk by participation in the protocol.
- •History of solid organ transplant.
- •History of alcohol or drug abuse within the past 2 years.
- •History of diagnosis of demyelinating disease such as but not limited to: • Multiple Sclerosis, • Acute Disseminated Encephalomyelitis, • Balo’s Disease (Concentric Sclerosis), • Charcot-Marie-Tooth Disease, • Guillain-Barre Syndrome, • human T-lymphotropic virus 1 Associated Myelopathy, • Neuromyelitis Optica (Devic’s Disease).
- •Planned surgery during the treatment period.
- •Participants who are Steinbrocker class IV functional capacity (incapacitated, largely or wholly bed-ridden or confined to a wheelchair, with little or no self-care).
- •Vaccination with live or live-attenuated virus vaccine within 3 months prior to screening or plan to receive one during the trial including at least 3 months after the last dose of study drug
- •Any non-live vaccine (eg, COVID-19) within 14 days prior to randomization or plan to receive one during the trial.
- •Participant with personal or family history of long QT syndrome.
- •Active malignancy, lymphoproliferative disease, or malignancy in remission for less than 5 years, except adequately treated (cured) localized carcinoma in situ of the cervix or ductal breast, or squamous cell carcinoma, or basal cell carcinoma of the skin.
- •Previous or current use of biologic therapy or targeted synthetic disease modifying anti-rheumatic drugs (tsDMARD - such as JAK inhibitors) for RA.
- •Use of oral glucocorticoid greater than prednisone 10 mg per day or equivalent per day, or a change in dosage within 4 weeks prior to screening. The dose of oral glucocorticoid must remain stable.
研究组 & 干预措施
Match placebo to test product
Placebo
干预措施: Match placebo to test product (Drug)
METHOTREXATE
Auxiliary
干预措施: METHOTREXATE (Drug)
SAR441566, SAR441566
Test
干预措施: SAR441566 (Drug)
结局指标
主要结局
Proportion of participants achieving at least 20% improvement from baseline in the American College of Rheumatology (ACR) score at week 12
Proportion of participants achieving at least 20% improvement from baseline in the American College of Rheumatology (ACR) score at week 12
次要结局
- Change from baseline in Disease activity score – C-reactive protein (DAS-28 CRP) at week 12
- Proportion of participants achieving at least 50% improvement from baseline in the ACR score at week 12
- Number of participants with Treatment-Emergent Adverse Events (TEAEs), serious AEs (SAEs), and AEs of special interest (AESIs)
- Plasma pre-dose concentrations of SAR441566
- Plasma post-dose concentrations of SAR441566
研究者
Clinical Sciences and Operations
Scientific
Sanofi-Aventis Research & Development
研究点 (30)
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