NCT00279422终止2 期
A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis
Facet Biotech0 个研究点目标入组 127 人开始时间: 2006年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 127
研究概览
简要总结
The purpose of this study is to compare the efficacy of visilizumab to placebo in subjects with intravenous steroid-refractory ulcerative colitis.
详细描述
PDL BioPharma, Inc. was formerly known as Protein Design Labs, Inc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (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
- 否
入选标准
- •Males and females, 18 years of age or older.
- •Diagnosis of ulcerative colitis (UC) verified by endoscopy within 60 months prior to consent.
- •Severe active disease, as defined by a Modified Truelove & Witts Severity Index (MTWSI; also known as Lichtiger score) ≥ 11 at consent, with a confirmatory MTWSI ≥ 10 on or after the fifth consecutive day of intravenous (IV)steroids and within 1 day prior to randomization.
- •Mayo score ≥ 10 and Mayo mucosal subscore ≥ 2 after a minimum of 3 consecutive days (ie, on or after the fourth consecutive day) of IV steroids.
- •Adequate contraception from the day of consent through 3 months after the last dose of study drug.
- •Negative serum pregnancy test.
- •Negative Clostridium difficile test.
- •Signed and dated informed consent and Health Insurance Portability and Accountability Act (HIPAA) if applicable.
排除标准
- •UC requiring immediate intervention or toxic megacolon requiring imminent intervention.
- •History of total proctocolectomy, or subtotal colectomy with ileorectal anastomosis.
- •Presence of Ileostomy.
- •White blood cell count less than 2.5 x 10^3/mcL; platelet count less than 150 x 10^3/mcL; or hemoglobin level less than 8 g/dL.
- •Active medically significant infections, particularly those of viral etiology, eg, known cytomegalovirus (CMV) colitis. This includes any incidence of medically significant opportunistic infections within the past 12 months.
- •Live vaccination within 6 weeks prior to randomization.
- •Significant organ dysfunction, including cardiac, renal, liver, central nervous system (CNS), pulmonary, vascular, gastrointestinal, endocrine, or laboratory abnormality.
- •History of myocardial infarction, coronary artery disease, congestive heart failure, or arrythmias within 6 months prior to consent.
- •History or treatment of lymphoproliferative disorder (LPD) or malignancy within the past 5 years (excluding nonmelanoma skin cancer or carcinoma in situ of the cervix).
- •Seropositivity for infection with human immunodeficiency virus (HIV-1), hepatitis B virus (HBV) surface antigen, or hepatitis C virus (HCV).
- •Pregnancy or nursing.
- •Treatment with a first dose of infliximab or another anti-tumor necrosis factor (TNF)-α drug within 4 weeks of randomization, or treatment with a subsequent dose of an anti-TNF-α drug within 2 weeks of randomization.
- •Treatment with cyclosporine or tacrolimus (FK506) within 2 weeks prior to randomization.
- •Treatment with any other investigational drugs or therapies within 60 days prior to randomization, except those mentioned in the two exclusion criteria above.
- •Unable or willing to discontinue any UC drug (including, but not limited to 6-mercaptopurine, azathioprine, or methotrexate), except glucocorticoids or 5-ASA, immediately prior to randomization.
- •Nontherapeutic levels of chronic antiseizure medications in subjects with a prior history of seizures.
- •Any condition that, in the investigator's opinion, makes the subject unsuitable for study participation.
研究组 & 干预措施
placebo
Placebo Comparator
干预措施: visilizumab (Drug)
visilizumab
Experimental
干预措施: visilizumab (Drug)
研究者
相似试验
进行中（未招募）
3 期
Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)Immunoglobulin A NephropathyIgANNCT06291376Alexion Pharmaceuticals, Inc.579
已完成
1 期
Ulcerative Colitis Study: Study of Visilizumab in Patients With Severe Ulcerative ColitisSevere Ulcerative ColitisNCT00267306Facet Biotech144
终止
3 期
Ravulizumab in Thrombotic Microangiopathy Associated With a TriggerThrombotic MicroangiopathyNCT04743804Alexion Pharmaceuticals, Inc.16
进行中（未招募）
3 期
A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) TherapyPsoriatic ArthritisNCT03675308AbbVie964
终止
3 期
A Study of Itolizumab in Combination With Corticosteroids for the First-Line Treatment of Acute Graft Versus Host Disease (EQUATOR)GVHDGraft Versus Host DiseaseAcute-graft-versus-host DiseaseAcute GVHDaGVHDNCT05263999Equillium158