CTIS2022-501464-18-00招募中1 期
A phase IIa, open label, Single-centre study to assess the initial antifibrotic efficacy, safety, tolerability, pharmacokinetic and pharmacodynamic profile of MBF-118 in Crohn’s disease patients with stenosis. - MBF-118CT-02
Medibiofarma S.L.0 个研究点目标入组 10 人开始时间: 2022年8月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •1.Male or nonpregnant, nonlactating females, age 18-75., 2.Diagnosis of CD based on clinical, endoscopic, and histologic evidence established at least 3 months prior to Screening., 3.Has mild to severe ileocolonic CD., 4.Participant has no more than 2 naïve or anastomotic small bowel strictures, By MRE or IU in the terminal ileum at Screening. A stricture is defined as: a.localized luminal narrowing (luminal = 50% relative to normal adjacent bowel); AND b.wall thickening (= 125% relative to adjacent bowel); AND c.length < 12 cm, 6.If participants are using a treatment for CD, they should be on a stable dose for at least 3 months prior to study commencement. Acceptable treatments include non-steroidal anti-inflammatory drugs (NSAIDs) and anti-inflammatory biologics., 7.Ability to participate fully in all aspects of this clinical trial. Full comprehension of consent language and written informed consent must be obtained from the participant and documented.
排除标准
- •1.CD-related complications: •Previous ileorectal anastomosis, or a proctocolectomy. Patients who have received colonic resection are allowed in this study. •Short bowel syndrome •Ileostomy, colostomy, small bowel stoma, or ileoanal pouch •Fistulae in or adjacent to an ileal stenosis. Participants with perianal fistulae could be included if not septic. Participants with internally penetrating fistulae are excluded. •Suspected or diagnosed active intra-abdominal or perianal abscess that has not been appropriately treated •Toxic megacolon, 10.Concurrent or previous participation in another clinical trial and received investigational therapy within 4 weeks or 5 half-lives (whichever is longer) prior to Screening. Fecal microbiota transplant (includes human microbiota-based therapeutics) within 4 weeks prior to Screening are allowed., 2.Use of corticosteroid treatment for symptoms of inflammatory bowel disease within the last 2 weeks. Corticosteroids should not be taken during the screening, treatment or follow-up periods of the trial., 3.History or current diagnosis of ulcerative colitis, indeterminate colitis, ischemic colitis, nonsteroidal anti-inflammatory drug (NSAID)-induced colitis, idiopathic colitis (i.e., colitis not consistent with CD), radiation colitis, microscopic colitis, colonic mucosal dysplasia, or untreated bile acid malabsorption., 4.Uncontrolled primary sclerosing cholangitis., 5.Malignancies or history of malignancy within 5 years of the initial screening visit (V1), except for adequately treated or completely excised non-metastatic basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ., 6.Has a severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration, or may interfere with the interpretation of study results, as determined by the investigator., 7.New York Heart Association Class III or IV congestive heart failure., 8.Clinically significant abnormal clinical laboratory values, vital signs, physical examination, or 12-lead electrocardiogram (ECG) at Screening or Baseline [PR = 220 msec, QRS =120 msec and QTc = 440 msec, bradycardia (<50 bpm) or clinically significant minor ST wave changes or any other abnormal changes on the screening ECG that would interfere with measurement of the QT interval]., 9.Systemic or opportunistic infections including: •Patients with active tuberculosis (TB) determined at Screening, defined as a positive QuantiFERON test, or a purified protein derivative (PPD) skin test. Patients who test positive and show symptoms of TB (abnormal chest x-ray, or positive sputum smear or culture, active TB bacteria in his/her body, usually feels sick and may have symptoms such as coughing, fever, and weight loss) will be excluded. Patients positive for TB who develop symptoms during the study period will be removed from the trial. An exception is made for subjects with a history of latent TB who are currently receiving treatment for latent TB, will initiate treatment for latent TB before the first dose of study treatment, or have documentation of completing appropriate treatment for latent TB within 3 years prior to the first dose of study treatment). Patients who test positive for TB during the study period but who do not show symptoms will be allowed to continue the study. •Active infection with HIV. •Evidence of positive h
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