2026-525191-26-00招募中4 期
Efficacy of top-down therapy with mirikizumab versus standard of care with azathioprine in patients with newly diagnosed, moderate-to-severe Crohn’s disease: A 52-week, multicenter, open-label, randomized controlled trial
Universitaetsklinikum Schleswig-Holstein AöR12 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2026年7月1日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 320
- 试验地点
- 12
研究概览
简要总结
To test the hypothesis that mirikizumab induction and maintenance therapy is superior to azathioprine/GC in achieving deep remission at Week 52 among patients, moderate-to-severe Crohn’s disease. In this analysis, any step-up from azathioprine to mirikizumab is classified as non-response (step-up rule A).
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Given written informed consent prior to any study-specific procedures.
- •Oral budesonide must be discontinued ≥2 weeks before screening colonoscopy. A switch to prednisolone is permitted. Oral mesalamine must be discontinued ≥2 weeks before screening colonoscopy.
- •Evidence of active Crohn’s disease at enrollment, defined as all of the following: a) CDAI 220–500 at screening and Week 0; and b) CRP > ULN and/or fecal calprotectin >250 µg/g measured during screening (Week -8 to Week 0); and c) Endoscopic activity on screening ileocolonoscopy (Week -8 to Week 0): SES-CD ≥4 for ileal-only (L1) disease; or SES-CD ≥6 for ileocolonic/colonic (L2/L3) disease (Eligibility may be based on local read; central read is used for endpoint assessments.).
- •No actively draining fistula at screening and baseline.
- •No prior CD-related surgery.
- •Willing and able to complete the scheduled study assessments, including ileocolonoscopy and daily Diary entry.
- •Willing to comply with contraception requirements (as specified in Section 7.7 Contraception requirements).
- •Age 18–75 years.
- •Naïve to thiopurines (azathioprine or 6-mercaptopurine) and methotrexate.
- •Naïve to advanced therapies (targeted biologic or small-molecule therapies) for Crohn’s disease or any other disease.
- •Early disease: Crohn’s disease diagnosed per DGVS/ECCO criteria ≤12 months and ≥4 weeks before Week 0 (randomization).
- •Prior 5-aminosalicylate (5-ASA) and/or oral glucocorticoid therapy with inadequate response, loss of response, or intolerance to the agent(s) received.
- •If receiving systemic GC at screening start: cumulative systemic GC exposure prior to screening start should be ≤8 weeks, and prednisolone ≤20 mg/day (or equivalent) should be stable for ≥2 weeks before screening colonoscopy.
排除标准
- •Acute severe/fulminant Crohn’s disease requiring immediate inpatient management or urgent surgery at screening (e.g., obstructive complication with imminent surgery, perforation, draining fistula, uncontrolled sepsis/abscess, toxic megacolon).
- •Planned receipt of live or live-attenuated vaccines (including Bacillus Calmette-Guerin, BCG) during screening or the study.
- •Systemic mycoses or parasitosis.
- •Unstable or uncontrolled illness that could increase risk or confound efficacy assessment, including but not limited to cerebro-cardiovascular, respiratory, gastrointestinal (other than CD), hepatic, renal, endocrine, hematologic, neurological disorders, or active malignancy.
- •Known systemic hypersensitivity to any study drug or any excipient, or prior acute systemic hypersensitivity to monoclonal antibodies that, in the investigator’s judgment, precludes mirikizumab therapy.
- •Women who are pregnant, lactating or planning pregnancy.
- •Employee of Lilly or any of the organizations involved with this study or study site personnel directly affiliated with this study and/or their immediate families.
- •Participation in another interventional clinical trial involving an investigational product or nonapproved use of a drug within the 12 weeks before screening, or concurrent enrollment in any other clinical study or any other type of medical research judged not to be scientifically or medically compatible with this trial.
- •Unwilling or unable to comply with eDiary/data-capture requirements or other study procedures for the duration of the study.
- •Committed to an institution by judicial or administrative order.
- •Oral and rectal 5-ASA or rectal steroids treatment within 2 weeks prior to screening colonoscopy.
- •History of malignancy, except for non-melanoma skin cancer that has been successfully treated and considered cured at screening.
- •Planned or foreseeable surgery at or before randomization (Week 0).
- •Known thiopurine methyltransferase deficiency or known inherited mutated nudix hydrolase 15 (NUDT15) gene.
- •Known hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption.
- •Diagnosis inconsistent with Crohn’s disease, including ulcerative colitis, indeterminate colitis, microscopic colitis, or other non-CD inflammatory enteropathies.
- •Clinically important active infection, including but not limited to hepatitis B, hepatitis C, HIV/AIDS, or active tuberculosis (TB).
- •Detectable hepatitis B virus (HBV) DNA or hepatitis C virus (HCV) RNA at screening.
研究组 & 干预措施
-, AZATHIOPRINE
Comparator
干预措施: AZATHIOPRINE (Drug)
MIRIKIZUMAB, MIRIKIZUMAB, MIRIKIZUMAB
Test
干预措施: MIRIKIZUMAB (Drug)
研究者
Office Prof. Stefan Schreiber
Scientific
Universitaetsklinikum Schleswig-Holstein AöR
研究点 (12)
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