A phase IIb, multicentre, randomised, double-blinded (DB), placebo-controlled, multi-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 200 人2014年11月27日

概览

暂无简介。

注册库

who.int

开始日期

2014年11月27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

•At the screening visit (V1\):
•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 endoscopic evidence of Crohn's diagnosis at least 1 year prior to V1 (an endoscopy will be perform if the one available has more than 1 year at V1\);
•4\) Elevated High sensitive C\-reactive protein (hs\-CRP) \> 10 mg/L at V1;
•5\) Calprotectin \= 250 µg/g;
•6\) Failure or intolerance to conventional treatments including corticosteroid, immunosuppressant and at least one biologic; 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);
•7\) Documented CDAI (Crohn's Disease Activity Index) \= 250 at V1 or within the past 3 months prior to V1;
•8\) Total white cell count \= 4\.0\.10^9 / L;
•9\) Platelets between 150\.10^9 and 600\.10^9 / L (included);

•1\) Current or recent history (12 preceding months before 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\) First degree family or personal history of clinically significant venous, arterial or pulmonary thromboembolism events;
•4\) History of thrombocytosis over 600\.10^9 / L in the previous 12 months prior to V1;
•5\) History of major immune deficiency disorder, except Crohn’s Disease;
•6\) Concomitant clinically active infection at V1 or V2 or V3 or V4 or V7 or V9 CATS29\-OL or V11 CATS29\-OL;
•7\) History of intestinal resection or intra\-abdominal surgery within 6 months prior to V1;
•8\) Have complication of Crohn’s Disease such as strictures, stenosis, short gut syndrome, or any other manifestation that might require surgery, could preclude the use of CDAI to assess response to therapy, or would possibly confound the evaluation of benefit from treatment with Ovasave;
•9\) Patients with intestinal functional fibrotic structuring responsible for the patient’s symptoms or previous major Gastro Intestinal (GI) resection;
•10\) Patients with short bowel syndrome or with less than 1\.5 m of small bowel;