NCT00820365已完成2 期
Exploratory, Open-label Study to Demonstrate Efficacy, Safety and Tolerability of SC12267 (35 mg) in Patients With Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 4SC AG
- 入组人数
- 34
- 试验地点
- 24
- 主要终点
- Efficacy of SC12267 (4SC-101) at a dose of 35 mg once daily in patients with Crohn's Disease (CD) or Ulcerative Colitis (UC) after a 12 week therapy as measured by the number of patients with complete or partial response.
研究概览
简要总结
This is an exploratory, open-label, uncontrolled, multi-center, 1-arm study conducted at 16 sites in Bulgaria, Germany and Romania.
A total of ca. 30 - 35 patients will receive SC12267 (4SC-101) tablets, 35 mg once daily for 12 weeks. First of all the patients will undergo a screening period of 1 week and a follow-up visit will be performed 4 weeks after study drug discontinuation or earlier in case of relapse during follow up. Total study duration will be up to 36 (+2) weeks.
There will be 8 study visits: one screening visit, 6 visits during the treatment period and one follow-up visit. In addition, four telephone visits will be performed at Week 6, Week 10, Week 20 (+1) and Week 36 (+2).
The duration of the entire study (first patient in till last patient out) is expected to be about 13 months.
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
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Criteria regarding Crohn´s Disease:
- •Established diagnosis of CD, confirmed by standard criteria (e.g. endoscopy, ultrasound, X-ray)
- •Patients must be in clinical remission (Crohn's Disease Activity Index [CDAI] <150 points) on steroid therapy for at least 2 weeks
- •Confirmed steroid-dependency of CD: patients who are either
- •unable to taper steroids completely within 3 months of starting steroids, without recurrent active disease, or
- •who have a relapse within 2 months of stopping steroids
- •Individual threshold* dose of previous relapses should be equal or less than 20 mg/day Prednisolone or equivalent steroid dose
- •Patients with stable glucocorticosteroid therapy between 20 and 40 mg/day Prednisolone or equivalent steroid dose for the previous week
- •Criteria regarding Ulcerative Colitis:
- •Established diagnosis of UC, confirmed by standard criteria (e.g. endoscopy, ultrasound, X-ray)
- •Patients must be in clinical remission (Clinical Activity Index [CAI] <4 points) on steroid therapy for at least 2 weeks
- •Confirmed steroid-dependency of UC: patients who are either
- •unable to taper steroids completely within 3 months of starting steroids, without recurrent active disease, or
- •who have a relapse within 2 months of stopping steroids
- •Individual threshold* dose of previous relapses should be equal or less than 20 mg/day Prednisolone or equivalent steroid dose
- •Patients with stable glucocorticosteroid therapy between 20 and 40 mg/day Prednisolone or equivalent steroid dose for the previous week
- •(* The threshold dose is that dose at which the patient experienced the relapses)
- •Criteria regarding general requirements:
- •Men and women, 18 to 70 years of age
- •Written informed consent
- •Negative pregnancy test at screening in females of child-bearing potential
- •Males willing to use condoms or to be sexually abstinent
- •Use of appropriate contraceptive methods for females of childbearing potential one month before, throughout the course of the study and one month after study termination. This must be a combination of the following:
- •a highly effective method of first choice = a method with a low failure rate (i.e. less than 1% per year) like sexual abstinence, combined oral contraceptives, implants, injectables, some Intra Uterine Devices (IUDs), vasectomized partner
- •together with
- •a method of second choice like condom, diaphragm, or cup pessary
排除标准
- •Criteria regarding gastrointestinal conditions:
- •Short bowel syndrome
- •Ileostomy, colostomy or rectal pouch
- •Relapse during screening
- •Criteria regarding medical history:
- •History of or existence of active tuberculosis
- •History of or existence of urolithiasis
- •History of or existence of human immune deficiency virus (HIV), Hepatitis B or C
- •History of malignancy within the past five years (excluding basal cell carcinoma of the skin)
- •Previous opportunistic infection
- •History of serious drug sensitivity
- •Criteria regarding concomitant diseases:
- •Significant cardiac arrhythmia, bradycardia or tachycardia or any other significant finding in the electrocardiogram (ECG)
- •Congestive heart failure
- •Uncontrolled arterial hypertension
- •Uncontrolled asthma
- •Renal disease
- •Renal insufficiency defined as glomerular filtration rate (GRF) <50 ml/min/1.73 m² (estimated GRF according to Cockcroft-Gault)
- •Psychiatric illness
- •Known or suspected immunodeficiency
- •Laboratory abnormalities: hemoglobin <8.5 g/dl, white blood cell count <3500/mm³, platelet count <125 000/mm³, clinically relevant elevation of liver enzymes, serum creatinine level >=1.4 mg/dl, hematuria (>=10 erythrocytes/field on dipsticks)
- •Criteria regarding concomitant circumstances:
- •Pregnancy, lactation
- •History of alcohol and/or drug dependence
- •Heavy smoking (more than 20 cigarettes per day)
- •Use of prohibited drugs or treatments
- •Patient not able or not willing to follow study procedures due to physical or psychological limitations or language problems
- •Participation in another investigational drug or vaccine trial within the last three months or concurrently with this study
- •Vaccination with life attenuated viruses within 4 weeks prior to study start
- •Patient with any medical condition which, in the opinion of the investigator or his designee, could jeopardize or compromise the ability of the patient to participate in the trial
- •Patients possibly dependent on the investigator or the sponsor
结局指标
主要结局
Efficacy of SC12267 (4SC-101) at a dose of 35 mg once daily in patients with Crohn's Disease (CD) or Ulcerative Colitis (UC) after a 12 week therapy as measured by the number of patients with complete or partial response.
时间窗: after a 12 week therapy
次要结局
- The secondary objective of this study is to evaluate the safety and tolerability of SC12267 (4SC-101) at a dose of 35 mg once daily in patients with CD or UC and to explore plasma levels (trough values) of SC12267 (4SC-101).(after a 12 week therapy)
研究者
研究点 (24)
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