EUCTR2013-004599-36-DE进行中（未招募）1 期
SB012 for the treatment of active ulcerative colitis (SECURE): a prospective, multi-centre, randomised, double-blind, placebo-controlled phase IIa clinical trial to evaluate the efficacy, pharmacokinetics, tolerability, and safety of SB012 enema administered once daily - SECURE
sterna biologicals GmbH & Co. KG0 个研究点目标入组 18 人开始时间: 2014年2月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •?Fully capable to give informed consent.
- •?Mentally able to understand the nature, significance, implications and risks of the clinical trial and to follow instructions of the trial staff.
- •?Written informed consent.
- •?Clinical Mayo Score of =3
- •?Total Mayo Score of =6.
- •?Endoscopic Mayo score =2 in the sigmoid.
- •?Body mass index =18.0 to =29.0kg/m2 and body weight =50 to =100kg.
- •?Negative urine pregnancy test (female subject only)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •Colectomy and presence of ileal pouch-anal anastomosis or ileorectal anastomosis.
- •Diagnosis of ulcerative proctitis.
- •Diagnosis of fulminant colitis.
- •Diagnosis of toxic megacolon.
- •Diagnosis of colitis indeterminata.
- •Diagnosis of Crohn’s disease.
- •Anti-TNFa treatment with adalimumab, certolizumab, etanercept, golimumab, or infliximab =4 weeks prior to screening visit [V1].
- •Change in systemic glucocorticoid treatment =1 weeks prior to screening visit [V1]
- •Change in 5-ASA therapy =1 week prior to screening visit [V1].
- •Start of treatment with an immunosuppressive agent =3 months prior to screening visit [V1].
- •Change in treatment with an immunosuppressive agent =4 weeks prior to baseline visit [V1].
- •Planned concomitant therapeutic administration of suppositories or foams or enema other than the IMP.
- •Impaired blood coagulation (Quick value <50% and/or PTT >55sec and/or platelet count <50.000/µl.
- •Signs of renal insufficiency.
- •Signs of hepatic insufficiency.
- •Current treatment with drugs of high hepatotoxic potential.
- •Evidence of recent alcohol abuse.
- •Acute or chronic heart failure with NYHA functional class III or IV.
- •Known active tuberculosis.
- •Known acute serious infections or sepsis.
- •Known current malignant disease.
- •Positive blood test against HBs antigen, anti-HBc antibodies, anti-HCV antibodies or anti-HIV-1/2 antibodies.
- •Known opportunistic infections including invasive fungal infections.
- •Known hypersensitivity to the IMP or any of their formulation ingredients.
- •Any condition that is thought to reduce the compliance to cooperate with the trial procedures.
- •Employee of the department of the investigator, of the CCS Erlangen, or of the sponsor.
- •Prior participation in this clinical trial.
- •Participation in an interventional clinical trial within the last three months (six months in case of a biological IMP) or be under the exclusion period from another clinical trial.
- •Known or planned absence that may collide with the clinical trial visit schedule.
研究者
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