CTRI/2022/11/047054招募中2 期
A phase 2 randomized, double-blind, parallel-group, placebo and active-controlled, two treatment period study to evaluate the safety and efficacy of Itolizumab for the induction of remission in biologics naïve patients with moderate to severely active ulcerative colitis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 17
- 主要终点
- Proportion of participants who achieved clinical remission per Total Mayo Score
研究概览
简要总结
This study aims to evaluate the safety and efficacy of Itolizumab for induction of remission in biologics naïve patients with moderate to severely active UC.
Additionally, PK, biomarkers and immunogenicity will also be assessed.
Based on previous studies with Itolizumab in other inflammatory conditions for the rationale for dosing, we anticipate Itolizumab to have a positive impact on
patients with UC. As an indication UC has the advantage of possible early signals to support proof-of-concept (PoC). For the induction of remission in UC, a
12 week-trial usually provides meaningful information on the ability of a potential therapy to induce clinical and endoscopic remission. Depending on the
outcome of this PoC study, the safety and efficacy of Itolizumab can be further confirmed in a phase 3 trial in UC patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or female, 18 years of age or older with diagnosis of moderate to severe active UC confirmed by endoscopy and histologic evidence at least 6 months prior to screening visit, as defined by a Mayo score 2.Patients naïve to biologic therapy (e.g., TNF antagonist) and have a prior OR current UC medication history.
- •3.Before the first administration of study drug, the following conditions must be met a.If receiving conventional immunomodulators (i.e., 6-MP or Azathioprine), must have been taking them for ≥12 weeks, and on a stable dose for at least 4 weeks.
- •4.A female patient has been sterilized or has been menopausal, or the patient has no pregnancy plan during the trial and voluntarily adopts effective contraceptive measures.
- •5.Able to comprehend the full nature and purpose of the study, including possible risks and side effects, and able to comply with all requirements of the study.
- •Must be able to understand and voluntarily sign an informed consent prior to any study procedures.
排除标准
- •1.Patient with Crohn Disease, indeterminate colitis microscopic colitis, ischemic colitis, or radiation induced colitis, based on medical history, endoscopy, and or histological findings or presence or history of fistula with Crohn Disease or current evidence of fulminant colitis 2.History of pancolitis for less than or equal to 8 years or left-sided colitis less than or equal to 15 years.
- •3.Extensive colonic resection or colectomy or imminent risk of colectomy, or prior history of toxic megacolon within 6 months of screening 4.History or current evidence of colonic dysplasia or adenomatous colonic polyps.
- •5.Active malignancy or carcinoma in situ within the last 5 years 6.Diagnosis of primary sclerosing cholangitis by liver function test.
- •7.Presence or history of active tuberculosis (TB) or latent TB infection, 8.Known acute or chronic viral hepatitis B or hepatitis C, or human immunodeficiency virus (HIV).
- •9.Other local or systemic pathological states requiring therapy with corticosteroids within 30 days prior to randomization except inhaled corticosteroids 10.Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination.
- •11.Does not agree to use contraception in the event of sexual activity for 130 days after the last dose of study drug if a female of childbearing potential or a male with a partner of childbearing potential.
- •12.Any serious inherited disorder, medical condition, or abnormality of clinical laboratory tests that, in the investigator judgment, precludes the patient safe participation in and completion of the study.
- •13.Evident renal disease or insufficiency, estimated glomerular filtration rate (eGFR) of <30 mL/min/1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI).
结局指标
主要结局
Proportion of participants who achieved clinical remission per Total Mayo Score
时间窗: Week 12
次要结局
- 2. Proportion who achieved clinical response per Total Mayo Score(Week 24)
- 3. Proportion who achieved Mucosal Healing.(Week 24)
- 4. Proportion who achieved endoscopic remission.(Week 24)
- Treatment Period 1(1.Proportion of Participants Who Achieved Clinical Response Per Total Mayo Score.)
- 2.Proportion of participants who Achieved Mucosal Healing.(Week 12)
- 3.Proportion of Participants who achieved endoscopic remission.(Week 12)
- Treatment Period 2 – Participants who were responders at Week 12(1.Proportion who achieved clinical remission per Total Mayo Score.)
- 2.Proportion who achieved Mucosal Healing(Week 24.)
- 3. Proportion who achieved endoscopic remission.(Week 24)
- Who were non-responders at Week 12(1. Proportion who achieved clinical remission per Total Mayo Score.)
- 5. Proportion who achieved Histologic Remission(Week 24)
研究者
研究点 (17)
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