EUCTR2016-000518-31-NL进行中（未招募）1 期
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF INDUCTION THERAPY WITH LYC-30937-EC IN SUBJECTS WITH ACTIVE ULCERATIVE COLITIS
ycera Corp.0 个研究点目标入组 120 人开始时间: 2016年6月27日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
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
- •1. Consenting adults aged 18–75 years.
- •2. Have had UC diagnosed at least 6 months prior to screening and with a minimum disease extent of = 15 cm from the anal verge. The diagnosis of UC must be confirmed by endoscopic and histologic evidence (histology may be confirmed at screening based on biopsy collection during the screening colonoscopy with histological evaluation done by the site).
- •3. Have active UC defined as a TMS of 4–11 (inclusive) with endoscopic subscore of = 2 and rectal bleeding subscore of = 1 at screening.
- •4. Male and female subjects of childbearing potential must agree to use adequate birth control measures during the study. Female subjects of child bearing potential must use two highly effective forms of contraception, unless surgically sterilized, partner has had a vasectomy, or they will be abstinent, during study participation and for 30 days after their last dose of study drug. Highly effective methods of birth control in this study include: intrauterine device, hormonal contraceptives (oral, patch, long acting injectable, implant), double-barrier method (condom or diaphragm with spermicide). (Post-menopausal defined as lack of menses for = 6 months prior to screening confirmed with serum FSH > 25 mIU/mL at screening.)
- •5. Must be currently receiving treatment with at least one of the following therapies (subjects need to be receiving medications consistent with standard of care and stable doses of medications need to be established prior to screening):
- •a. Oral aminosalicylates (eg, mesalamine, sulfasalazine, olsalazine, balsalazide) for
- •= 6 weeks with the dose stable for = 3 weeks prior to the Screening endoscopy.
- •b. Prednisone (dose = 20 mg daily) or equivalent for = 4 weeks and receiving a stable dose for = 2 weeks prior to the screening endoscopy.
- •6. If oral aminosalicylates (ASA) or corticosteroids have been recently discontinued, they must have been stopped for = 2 weeks prior to the screening endoscopy (eg, if recently tapered off coricosteroid).
- •7. Ability to provide written informed consent and to be compliant with the schedule of events
- •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 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1. Known mitochondrial disorder.
- •2. History of CD or indeterminate colitis or the presence or history of a fistula consistent with CD.
- •3. History of bleeding disorders (eg, complement disorders, hemophilia, history of uncontrolled bleeding).
- •4. Severe extensive disease that in physician judgment the subject is likely to require colonic surgery during the 8 week double-blind course (eg, fulminant colitis, toxic megacolon, bowel perforation, evidence of an acute abdomen).
- •5. Positive test for Clostridium (C.) difficile, positive stool culture for enteric pathogens (eg, Salmonella, Shigella, Campylobacter), or presence of ova or parasites at screening.
- •Note that C. difficile may be treated and the subject may be retested for screening after
- •he/she completed this treatment.
- •6. Any of the following laboratory abnormalities:
- •a. liver function tests > 1.5 x the upper limit of normal (ULN) or direct bilirubin > 1.5 x ULN.
- •b. hemoglobin < 8.5 g/dl (international system units [SI]: < 85 g/L).
- •c. neutrophils < 1500/mm3 (SI: < 1.5 x 109/L).
- •d. white blood cell (WBC) count < 3,000/mm3 (SI: < 3.0 x 109/L).
- •e. Platelets < 80,000 mm3 (SI: 80 x 109/L).
- •f. international normalized ratio (INR) > 1.5.
- •g. serum creatinine > 1.4 mg/dL for women or > 1.6 mg/dL for men.
- •7. Have had treatment with immunosuppressant agents (eg, cyclosporine, azathioprine,
- •mercaptopurine, methotrexate, tacrolimus, sirolimus, or mycophenolate mofetil (MMF)
- •within 8 weeks prior to initiation of screening procedures.
- •8. Pregnancy, lactation, or a positive serum beta human chorionic gonadotropin (hCG) at
- •screening. Female subjects should not be planning to become pregnant while enrolled in the trial.
- •9. Clinically relevant hepatic, neurological, pulmonary, ophthalmological, gastrointestinal, endocrine, psychiatric, or other major systemic disease making implementation of the protocol or interpretation of the study difficult or that would put the subject at risk by participating in the study.
- •10. History of uveitis within the 12 months prior to initiation of screening procedures.
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