CTIS2023-504328-25-00招募中1 期
A parallel-group treatment, Phase 2, double-blind, placebo controlled study to evaluate the efficacy and safety of SAR444656 in adult participants with moderate to severe hidradenitis suppurativa. - ACT17841
Sanofi-Aventis Recherche & Developpement0 个研究点目标入组 158 人开始时间: 2023年8月9日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 158
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Participant with a history of signs and symptoms consistent with HS for at least 1 year prior to baseline., Participant must have HS lesions present in at least 2 distinct anatomic areas, one of which must be Hurley Stage II or Hurley Stage III., Participant must have had an inadequate response to at least a 3-month treatment of an oral antibiotic for treatment of HS as assessed by the Investigator., Participant must have a total AN count of =5 at the baseline visit., Participant must have a draining tunnel count of =20 at the baseline visit., Participant must have a CRP >3 mg/L obtained at screening., Participant must be willing and able to complete the diary for the duration of the study as required by the study protocol., Contraceptive use by men with a partner of childbearing potential and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
排除标准
- •Participant with any other active skin disease or condition (eg, bacterial, fungal, or viral infection) that may interfere with assessment of HS., Participant with congestive heart failure (New York Heart Association Class 2 to 4), greater than Class 1 angina pectoris, acute coronary syndrome within prior 6 months, known structural heart disease., Participant with history of any major cardiovascular events (eg, myocardial infarction, unstable angina pectoris, coronary revascularization, stroke, or transient ischemic attack) at any time prior to screening., Participant with history of ventricular fibrillation, ventricular tachycardia, torsades de pointes, atrial fibrillation, syncope not explained by non-cardiac etiology., Participant with uncontrolled hypertension defined as consistent systolic blood pressure =150 mmHg or consistent diastolic blood pressure =90 mmHg despite antihypertensive medication., Participant received prescription topical therapies for the treatment of HS within 14 days prior to the baseline visit., Participant received prescription topical therapies for the treatment of HS within 14 days prior to the baseline visit., Any active or chronic infection requiring systemic treatment (eg, antibiotics, antivirals, antifungals, antihelminthics) within 30 days prior to baseline., Known history of or suspected significant suppressed immune response, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration., Participant with history of solid organ transplant., Participant with history of splenectomy., Participant with history of any malignancy or lymphoproliferative disease, except if the participant has been free from disease for =5 years. Successfully treated non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma, or localized carcinoma in situ of the cervix are allowed., Participant with a diagnosis of chronic immune-mediated, inflammatory conditions other than HS, Participant with family history of sudden death or long QT syndrome., Participant with history of congenital or drug-induced long QT syndrome.
研究者
相似试验
进行中（未招募）
1 期
A study to learn how well the treatment combination of finerenone and empagliflozin works and how safe it is compared to each treatment alonein adult participants with long-term kidney disease (chronic kidney disease) and type 2 diabetesChronic kidney disease in type 2 diabetes mellitusMedDRA version: 21.1Level: LLTClassification code 10045250Term: Type II diabetes mellitus with renal manifestationsSystem Organ Class: 10038359 - Renal and urinary disordersEUCTR2021-003037-11-DKBayer AG807
招募中
2 期
Combination of finerenone and empagliflozin in participants with Kidney disease and Type 2DiabetesCTRI/2023/09/057826Fortrea Development India Private Limited
进行中（未招募）
1 期
A study to learn how well the treatment combination of finerenone and empagliflozin works and how safe it is compared to each treatment alone in adult participants with long-term kidney disease (chronic kidney disease) and type 2 diabetesEUCTR2021-003037-11-ESBayer AG807
已完成
2 期
A study to learn how well the treatment combination of finerenone and empagliflozin works and how safe it is compared to each treatment alone in adult participants with long-term kidney disease (chronic kidney disease) and type 2 diabetes.2023-506981-30-00Bayer AG220
招募中
2 期
Combination of finerenone and empagliflozin in participants with CKD and T2DChronic Kidney Disease and Type 2 DiabetesJPRN-jRCT2071220067Myoishi Masafumi807