EUCTR2019-003113-34-SK进行中（未招募）1 期
A randomized, multi-center, subject and investigator blinded, placebo controlled, parallel group study to assess the efficacy, safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitis
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 45
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
- •The patients eligible for inclusion in this study must fulfill all of the following criteria:
- •1. Written informed consent must be obtained before any assessment is performed.
- •2. Male and female subjects aged 18-75 years at Screening.
- •3. Patients diagnosed with UC established at least 3 months prior to screening.
- •4. Patients with mild to moderate UC which is defined by a total Mayo Score between 5 and 10 (inclusive),comprised of the following subscores;
- •- Endoscopic subscore: 2 or 3 (determined from central reading of screening endoscopy)
- •- Stool frequency subscore: 1-3
- •- Rectal bleeding subscore: 1-3
- •- Physician's global assessment subscore: 1-2.
- •5. Disease must extend beyond 15 cm from the anal verge (assessed by screening endoscopy).
- •6. Patients must have responded inadequately or have intolerance to conventional therapy with oral 5-ASA prior to screening , and be willing to continue 5-ASA at a stable dose during the study treatment period.
- •7. Able to communicate well with the investigator, to understand and comply with the requirements of the study.
- •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 33
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •The patients fulfilling any of the following criteria are not eligible for inclusion in this study:
- •- Use of investigational drugs within 4 weeks or 5 half-lives of screening, whichever is longer; or longer if required by local regulations.
- •- Confirmed laboratory findings at screening showing:
- •Total white blood cell count (WBC) outside the range of 3,000 – 12,000 /µL.
- •o Subjects with mild leukocytosis (WBC not higher than 15,000 /µL) may be eligible, if the elevated WBC, according to the Investigator, is attributable to disease activity and/or to corticosteroid therapy and other causes such as hematological or infectious diseases can be excluded;
- •Platelets <100,000/µL;
- •Hemoglobin <9 g/dL and/or other signs of severe anemia
- •- Are taking any of the prohibited medications listed in Table 6 2 and do not fulfill the washout period.
- •- Patients receiving concomitant medication(s) that is/are known to inhibit OAT3 and that cannot be discontinued or replaced by safe alternative medication within 5 halflives or 1 week (whichever is longer) prior to baseline and for the duration of the study.
- •- Has severe UC during the screening period.
- •- Has previous diagnosis with Crohn's disease, indeterminate colitis, microscopic colitis or acute diverticulitis based on medical history.
- •- Any severe, progressive or uncontrolled medical or psychiatric condition, or other factors at randomization that in the judgment of the investigator prevents the patient from participating in the study.
- •- Active systemic infections (other than common cold) during the 2 weeks prior to randomization. Evidence of Clostridium difficile infection within 8 weeks or other intestinal pathogen infection within 4 weeks prior to the first dose of study drug.
- •- History of toxic megacolon, abdominal abscess, symptomatic colonic stricture, or stoma; history or is at risk of colectomy.
- •- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test at Screening.
- •- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using basic methods of contraception during dosing of study Treatment.
- •- Patients with clinically relevant primary sclerosing cholangitis
- •- Patients who previously received more than one class of biologic therapy for UC (i.e. anti- TNF blockers).
- •- History or current evidence of colonic dysplasia or adenomatous colonic polyps.
- •Other protocol-defined exclusion criteria may apply.
研究者
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