CTIS2023-509738-20-00招募中1 期
A Phase 4 Multicenter, Randomized, Open-label, Efficacy Assessor-blinded-Study of Risankizumab Compared to Deucravacitinib for the Treatment of Adult Subjects with Moderate Plaque Psoriasis who are Candidates for Systemic Therapy - M24-541
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 336
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
- •Male or female adults (18 years or above) who are candidates for systemic therapy with a diagnosis of moderate chronic plaque PsO (with or without PsA) for at least 6 months prior to Baseline (Day 1), who have not previously been treated with biologics and at Screening and Baseline have been defined as: •BSA = 10% and = 15%; •PASI = 12; and •sPGA = 3 (moderate) based on a 5-point scale (0 to 4)
排除标准
- •Employees of the sponsor and/or study sites and their family members may not be enrolled in this study., Subjects with evidence of Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, Human immunodeficiency virus (HIV), Active TB, Active systemic infection/Clinically important infection during the last 2 weeks prior to Baseline visit as assessed by the investigator., Subjects with any of the following medical diseases or disorders: recent (within past 6 months) cerebrovascular accident or myocardial infarction; history of an organ transplant which requires continued immunosuppression; active or suspected malignancy or history of any malignancy within the last 5 years; prior history of suicide attempt at any time in the subject's lifetime prior to signing the informed consent and randomization, hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption., Subjects with concurrent clinically significant medical conditions other than the indication being studied or any other reason that the investigator determines would interfere with the subject's participation in this study., Laboratory values meeting the following criteria within the Screening period prior to the first dose of study drug., Subjects with any form of PsO other than chronic plaque PsO., Subjects with a history of current drug-induced PsO or a drug-induced exacerbation of pre-existing PsO., Subjects with a history of active ongoing inflammatory skin diseases other than PsO., Subjects with a history of severe renal insufficiency defined as creatinine clearance < 30 mL/min and/or requiring hemodialysis or peritoneal dialysis., Subjects with a history of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months., Subjects with a history of an allergic reaction or significant sensitivity to constituents of the study drugs (and its excipients) and/or other products in the same class., Subjects who have had major surgery performed within 12 weeks prior to randomization or planned during the conduct of the study.
研究者
相似试验
进行中（未招募）
1 期
A study to assess whether Radium-223 dichloride is more efficient and safer treatment than novel anti-hormonal (NAH) therapy in patients with prostate cancer.Metastatic castration resistant prostate cancer (mCRPC)MedDRA version: 21.1Level: LLTClassification code 10076506Term: Castration-resistant prostate cancerSystem Organ Class: 100000004864EUCTR2019-000476-42-ITBayer Consumer Care AG696
进行中（未招募）
1 期
Investigation of Radium-223 dichloride (Xofigo), a treatment that gives off radiation that helps kill cancer cells, compared to a treatment that inactivates hormones (new antihormonal therapy, NAH) in patients with prostate cancer that has spread to the bone getting worse on or after earlier NAH.Metastatic castration resistant prostate cancer (mCRPC)MedDRA version: 21.1Level: LLTClassification code 10076506Term: Castration-resistant prostate cancerSystem Organ Class: 100000004864EUCTR2019-000476-42-FIBayer Consumer Care AG696
进行中（未招募）
1 期
Investigation of Radium-223 dichloride (Xofigo), a treatment that gives off radiation that helps kill cancer cells, compared to a treatment that inactivates hormones (new antihormonal therapy, NAH) in patients with prostate cancer that has spread to the bone getting worse on or after earlier NAH.EUCTR2019-000476-42-LTBayer Consumer Care AG696
进行中（未招募）
1 期
Investigation of Radium-223 dichloride (Xofigo), a treatment that gives off radiation that helps kill cancer cells, compared to a treatment that inactivates hormones (new antihormonal therapy, NAH) in patients with prostate cancer that has spread to the bone getting worse on or after earlier NAH.Metastatic castration resistant prostate cancer (mCRPC)MedDRA version: 21.1Level: LLTClassification code 10076506Term: Castration-resistant prostate cancerSystem Organ Class: 100000004864EUCTR2019-000476-42-DEBayer Consumer Care AG696
进行中（未招募）
1 期
A study to assess whether Radium-223 dichloride is more efficient and safer treatment than novel anti-hormonal (NAH) therapy in patients with prostate cancer.Metastatic castration resistant prostate cancer (mCRPC)MedDRA version: 21.1Level: LLTClassification code 10076506Term: Castration-resistant prostate cancerSystem Organ Class: 100000004864EUCTR2019-000476-42-GBBayer Consumer Care AG696