A phase IIb, multicentre, randomised, double-blinded (DB), placebo-controlled, single-dose and multi-injection, parallel groups study to evaluate the efficacy and the safety of Ovasave (ovalbumin-specific autologous Treg cells (ova-Treg)) in patients with active refractory Crohn’s Disease (Crohn’s And Treg Study: CATS29) - CATS29

TxCell0 个研究点目标入组 170 人2014年11月19日

概览

暂无简介。

注册库

who.int

开始日期

2014年11月19日

结束日期

待定

最后更新

9年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

TxCell

•Patients with active refractory Crohn's Disease, meeting the following criteria:
•1\) Willing and able to provide written Informed Consent (IC);
•2\) Male or Female aged between 18 and 70 (inclusive) years of age;
•3\) Crohn's Disease diagnosis defined as patients with medical history of signs, symptoms and biological evidence of active bowel inflammation:
•\- Documented Magnetic Resonance Imaging (MRI) or endoscopic evidence of inflammatory bowel disease (IBD), compatible with Crohn's diagnosis at least 1 year prior to V1;
•\- Available endoscopy or MRI, performed within 1 year prior to V1\. If the one available has more than 1 year at V1 a new exam (endoscopy or MRI) needs to be performed prior V2;
•4\) Documented CDAI (Crohn's Disease Activity Index) \= 250 at V1 or within 12 weeks prior to V1;
•5\) Elevated High sensitive C\-reactive protein (hs\-CRP) \> 10 mg/L at V1;
•6\) Calprotectin \= 250 µg/g at V1;
•7\) Failure or intolerance to conventional treatments including corticosteroid, immunosuppressant and at least one biologics; and had not responded (primarily failure) or responded and then lost response completely (no response or need to increase the dose / secondary failure) or were intolerant to this therapy at a dose indicated for CD (Refer to Appendix 17\.6 for the definition of refractoriness);

•Patients presenting with any of the following will not be included in the study:
•1\) Current or recent history (within 1 year prior to V1\) of major organ or system failure or condition, acute or chronic that in the opinion of the Investigator should preclude enrolment, except Crohn's Disease;
•2\) Current or previous history of malignancy except a local basal cell carcinoma without metastases;
•3\) History of major immune deficiency disorder, except Crohn's Disease;
•4\) Gamma immunoglobulinaemia \< 6 g/L at V1 or any signs or history of major immune deficiency disorder;
•5\) First degree family or personal history of clinically significant venous, arterial or pulmonary thromboembolism events;
•6\) History of thrombocytosis over 600\.10e9 / L within 1 year prior to V1;
•7\) History of tuberculosis (TB) except if documentation of adequate compliance to treatment is provided; Test to be performed at V1 if not already done in the 12 weeks prior to V1;
•8\) Concomitant clinically active infection;
•9\) Serious infection (as per definition of sepsis) within 12 weeks prior to V1;