NCT04948554终止1 期
A Phase 1b Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of ACE-1334 Plus Standard of Care in Participants With Systemic Sclerosis
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA32 个研究点 分布在 4 个国家目标入组 5 人开始时间: 2023年3月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 32
- 主要终点
- Number of Participants with ≥1 Adverse Event (AE)
研究概览
简要总结
The purpose of the MK-2225-002 (A1334-02) study is to evaluate the safety and tolerability of MK-2225 (ACE-1334) plus standard of care (SOC) in participants with Systemic Sclerosis (SSc) following multiple doses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, 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
- •The main inclusion and
排除标准
- •include but are not limited to the following:
- •Inclusion Criteria:
- •Participants must have SSc, as defined using the 2013 American College of Rheumatology/European League Against Rheumatism criteria
- •If participant is on a non-excluded immunosuppressive therapy (e.g. mycophenolate, methotrexate, azathioprine, etc.) the dose should be stable for > 2 months at the time of screening
- •Women of childbearing potential must:
- •If sexually active, have used, and agree to use, highly effective contraception without interruption, for at least 28 days prior to starting investigational product, during the study (including dose interruptions), and for 17 weeks (119 days) after discontinuation of study treatment
- •Refrain from breastfeeding a child or donating blood, eggs, or ovum for the duration of the study and for at least 17 weeks (119 days) after the last dose of study treatment
- •Male participants must:
- •Agree to use a condom, defined as a male latex condom or nonlatex condom NOT made out of natural (animal) membrane (e.g., polyurethane), during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions, and for at least 17 weeks (119 days) following investigational product discontinuation, even if he has undergone a successful vasectomy
- •Refrain from donating blood or sperm for the duration of the study and for 17 weeks (119 days) after the last dose of study treatment
- •Must agree to not participate in any other study of investigational drugs/devices while enrolled in this study
- •Exclusion Criteria:
- •Participant with SSc-pulmonary arterial hypertension (PAH) (except those participants with mild PAH on up to 2 oral drugs and mean pulmonary arterial pressure < 30 mmHg or low risk by risk calculator)
- •In the opinion of the investigator, other clinically significant pulmonary abnormalities (such as obstructive lung disease, asthma, etc.)
- •Other investigational therapy received within 1 month or 6 half-lives (whichever is greater) prior to the Screening Visit
- •Prior exposure to MK-2225 or other TGF-β antibodies or any TGF-β family targeted biologic or hypersensitivity to the components of MK-2225
- •Hypersensitivity to placebo or any of its components
- •Previous hematopoietic stem cell transplantation (HSCT) or HSCT planned within the next year
- •Major surgical procedures planned during the study period
- •Oral prednisone or equivalent > 10 mg/day
- •Participant with history of gastric antral vascular ectasia or gastrointestinal bleed
- •On anticoagulation therapy (such as prophylaxis anticoagulation, warfarin, direct thrombin inhibitors or other including low molecular weight subcutaneous or intravenous therapeutic heparin), or antiplatelet therapy including aspirin. Use of fish oil supplements within 2 weeks prior to randomization and throughout study is not permitted.
- •History of any other medical condition that might interfere with a participant's ability to participate in the study
- •Active clinically significant viral, bacterial, or fungal infection, or any episode of infection requiring hospitalization within 4 weeks prior to screening
- •Use of cyclophosphamide ≤ 6 months from screening
- •Use of nintedanib or pirfenidone ≤ 28 days from screening
- •Recent scleroderma renal crisis < 6 months before screening
- •Use of tocilizumab ≤ 2 months from screening
- •Has received any nonlive vaccine starting from 14 days prior to study intervention or is scheduled to receive any nonlive vaccine through 30 days following study intervention. Exception: COVID-19 vaccine may be administered.
结局指标
主要结局
Number of Participants with ≥1 Adverse Event (AE)
时间窗: Up to 20 Weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE will be reported.
Number of Participants Discontinuing from Study Therapy Due to AE
时间窗: Up to 12 Weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued study treatment due to an AE will be reported.
次要结局
- Serum Maximum Concentration (Cmax) of MK-2225(Up to 12 Weeks)
- Time to peak Serum Concentration (Tmax) of MK-2225(Up to 12 Weeks)
- Area Under the Concentration-Time Curve (AUC0-tau) of MK-2225(Up to 12 Weeks)
- Serum Apparent Terminal Half-Life (t1/2) of MK-2225(Up to 12 Weeks)
- Accumulation ratio of AUCtau (RAUC)(Up to 12 Weeks)
研究者
研究点 (32)
Loading locations...
相似试验
终止
1 期
A Study of MK-2206 in Combination With Trastuzumab and Lapatinib for the Treatment of HER2+ Solid Tumors (MK-2206-015)Advanced Solid TumorsBreast CancerNCT00963547Merck Sharp & Dohme LLC33
已完成
2 期
ZK 230211 in Postmenopausal Woman With Metastatic Breast CancerMetastatic Breast CancerNCT00555919Bayer68
已完成
1 期
A Study to Test Once-Weekly Doses of Odanacatib (MK0822) on Healthy Adult Females (0822-005)(COMPLETED)OsteoporosisNCT00770159Merck Sharp & Dohme LLC78
终止
2 期
Efficacy and Safety of MK-1942 as an Adjunct Therapy in Participants With Mild to Moderate Alzheimer's Disease Dementia (MK-1942-008)Alzheimer's DiseaseNCT05602727Merck Sharp & Dohme LLC99
已完成
2 期
MK0249 for the Treatment of Cognitive Impairment in Patients With Schizophrenia (0249-016)Paranoid SchizophreniaNCT00506077Merck Sharp & Dohme LLC55