NCT05351554终止2 期
A Randomized, Double-blind, Placebo-controlled, Phase 2a Study With an Open-label Cohort to Assess the Safety, Tolerability, and Efficacy of Namilumab in Subjects With Active Cardiac Sarcoidosis
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation
研究概览
简要总结
A Randomized, Double-blind, Placebo-controlled, Study with an Open-label Cohort.
详细描述
Study was terminated after a single participant had received 2 doses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None (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
- 是
入选标准
- •Male or female age ≥18 years
- •Able and willing to provide written informed consent, which includes compliance with study requirements and restrictions listed in the consent form
- •History of documented sarcoidosis (must include histological confirmation, from any organ, in the subject's medical history or records)
- •Meet Heart Rhythm Society Cardiac Sarcoid Diagnostic Criteria (modified)
- •Female subjects must agree to use an approved highly effective birth control (BC) method
- •Male subjects must agree to, and attest that, female partners of childbearing potential are using one of the allowed highly effective methods of contraception
- •Body Mass Index (BMI) <40 kg/m2 at Screening.
- •Vaccination for COVID-19 with completion of the primary series at least 2 weeks prior to randomization
排除标准
- •Hospitalized for any respiratory or cardiac illness ≤30 days prior to Screening
- •Known pulmonary hypertension requiring therapy
- •Autoimmune disease other than sarcoidosis likely to require treatment during the subject's participation in this study
- •Symptoms and/or signs of extracardiac sarcoidosis that are likely to warrant treatment in addition to that required for the subject's cardiac disease
- •Estimated glomerular filtration rate (eGFR) ≤30 mL/min/1.73 m2 (Modification of Diet in Renal Disease [MDRD] equation) or requiring renal replacement therapy
- •Hemoglobin ≤9.5 g/dL
- •Participation in another interventional clinical trial within 6 months prior to Screening and throughout the duration of participation in this study
- •Systolic blood pressure (SBP) <90 or >180 mm Hg; Diastolic blood pressure (DBP) <60 or >110 mm Hg at Screening
- •Has documented laboratory-confirmed severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection as determined by polymerase chain reaction (PCR) or other approved clinical testing ≤3 months prior to randomization
- •Significant valvular heart disease known or anticipated to require surgical repair or replacement during the subjects' participation in this study
- •Female subjects who are pregnant or breastfeeding or intend to be, during the study
- •History of severe allergic or anaphylactic reactions to therapeutic proteins or known sensitivity to namilumab or to its inactive components
- •Any other acute or chronic medical condition, that in the judgment of the Investigator or Sponsor, may increase the risk associated with study participation or investigational product administration, or may interfere with the interpretation of study results, and would make the participant inappropriate for entry into this study
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Namilumab
Experimental
A single participant received two doses of 150 milligrams (mg) of namilumab subcutaneously (SC) at baseline (Day 1) and on Day 15.
干预措施: Namilumab (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation
时间窗: Baseline up to approximately 2 months
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
次要结局
- Mean Change From Baseline in Positron Emission Tomography (PET) Maximum Standardized Update Value (SUVmax)(Baseline up to approximately 2 months)
- Number of Participants With Treatment-emergent Laboratory Abnormalities(Baseline up to approximately 2 months)
- Number of Participants With Treatment-emergent Vital Sign Abnormalities(Baseline up to approximately 2 months)
- Number of Participants With Treatment-emergent Electrocardiogram (ECG) Abnormalities(Baseline up to approximately 2 months)
- Change From Baseline in PET Mean Standardized Update Value (SUVmean)(Baseline up to approximately 2 months)
- Mean Change From Baseline in Total Glycosylation(Baseline up to approximately 2 months)
- Number of Participants Hospitalized for Cardiac Events(Baseline up to approximately 2 months)
- Mean Change From Baseline in Left Ventricular Ejection Fraction (LVEF)(Baseline up to approximately 2 months)
- Mean Change From Baseline in Global Longitudinal Strain (GLS) on Transthoracic Echocardiogram (TTE)(Baseline up to approximately 2 months)
- Cumulative Oral Steroid Use(Baseline up to approximately 2 months)
- Modified Glucocorticoid Toxicity Index (mGTI)(Baseline up to approximately 2 months)
- Mean Change From Baseline in Glycosylated Hemoglobin (HbA1C)(Baseline up to approximately 2 months)
- Number of Participants Requiring Rescue Therapy(Baseline up to approximately 2 months)
- Number of Participants Successfully Achieving Steroid Taper Without Requiring Rescue Therapy (Cohort A)(Baseline up to approximately 2 months)
- Mean Change From Baseline in King's Sarcoidosis Questionnaire (KSQ)(Baseline up to approximately 2 months)
- Change From Baseline in Fatigue Assessment Scale (FAS)(Baseline up to approximately 2 months)
- Change From Baseline in Subject Global Assessment (SGA)(Baseline up to approximately 2 months)
研究者
研究点 (1)
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