NCT07625293招募中2 期
A Phase 2a Study of DB-3Q for the Treatment of Medically Refractory Crohn's Disease
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 2
研究概览
简要总结
This research study is studying DB-3Q as a possible treatment for medically refractory Crohn's disease. The purpose of this study is to research and evaluate safety and effectiveness of the administration of bone marrow mesenchymal stem cell (bmMSC) derived extracellular vesicles product, DB-3Q, the study drug for Crohn's disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Sponsor
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent from participant
- •Males and females 18-75 years of age
- •Diagnosed with Crohn's disease of at least 6 months duration with medically refractory symptoms that failed to respond or responded but recurred after one advanced immunologic therapy (must have been receiving at least one advanced immunological therapy for 14 weeks duration prior to screening, including, but not limited to, adalimumab, certolizumab, , infliximab, risankizumab, upadacitinib, ustekinumab and vedolizumab), or is intolerant, or has a contraindication to advanced immunological therapy with a next step of subtotal colectomy or escalation in medical management
- •Active CD as defined by a CDAI score ≥ 220 and/or SES-CD score ≥ 4
- •Exposure to corticosteroids, 5-aminosalicylic acid (5-ASA) drugs, thiopurines, methotrexate, anti-TNF therapy, anti-integrin and anti-interleukin in the past are permitted but a washout period of 8 weeks for any monoclonal antibody is necessary
- •If receiving conventional immunomodulators (i.e., azathioprine [AZA], mercaptopurine [6-MP], or methotrexate [MTX]), must have been taking them for ≥12 weeks, and on a stable dose for at least 4 weeks prior to initial administration of IMP
- •If AZA, 6-MP, or MTX has been recently discontinued, it must have been stopped for at least 4 weeks prior to initial administration of IMP
- •If receiving oral 5-ASA compounds, the dose must have been stable for at least 4 weeks. If receiving oral corticosteroids, the dose must be ≤20 mg/day prednisone or its equivalent and must have been stable for at least 4 weeks prior to initial administration of IMP
- •If receiving budesonide, the dose must have been stable for at least 2 weeks prior to initial administration of IMP
- •If oral 5-ASA compounds or oral corticosteroids (including budesonide) have been recently discontinued, they must have been stopped for at least 2 weeks prior to initial administration of IMP
- •The following medications/therapies must have been discontinued before initial administration of IMP:
- •Monoclonal therapy (e.g., adalimumab, certolizumab, infliximab, risankizumab, ustenkinumab, and vedolizumab) for at least 8 weeks
- •Cyclosporine, tacrolimus, or sirolimus, for at least 4 weeks
- •6-thioguanine (6-TG) must have been discontinued for at least 4 weeks
- •JAK inhibitors (e.g., upadacitinib) must have been discontinued for at least 4 weeks
- •Rectal corticosteroids (i.e., corticosteroids [including budesonide] administered to the rectum or sigmoid colon via foam or enema or suppository) for at least 2 weeks
- •Rectal 5-ASA compounds (i.e., 5-ASAs administered to the rectum or sigmoid colon via foam or enema or suppository) for at least 2 weeks
- •Parenteral corticosteroids for at least 2 weeks
- •Total parenteral nutrition for at least 2 weeks
- •Antibiotics for the treatment of CD (e.g., ciprofloxacin, metronidazole, or rifaximin) for at least 2 weeks
- •No colonic dysplasia and malignancy as ruled out by colonoscopy within 90 days prior to initial administration of IMP
- •If participant is of reproductive capacity, willing to use adequate birth control measures while in the study
排除标准
- •Lack of informed consent
- •Pregnant woman, woman of childbearing potential without a documented negative urine or serum pregnancy test, or woman who is breast feeding
- •Clinically significant medical conditions within the six months before initial administration of IMP: e.g., myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the participant
- •Confirmed Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C infections
- •Aspartate aminotransferase (AST) or Alanine transaminase (ALT) greater than 3 times the upper limit of normal at screening
- •Abnormal basic laboratory values with the following cut-offs:
- •Alkaline phosphate > 200 U/L
- •WBC >13 109/L
- •Hemoglobin < 7 g/dL
- •Platelets < 50 or > 109/L
- •eGFR < 60 mL/min/1.73m2
- •HbA1C > 8%
- •Prothrombin time (PT), partial thromboplastin time (aPTT) or international normalized ratio (INR) greater than 1.5 times the upper limits of normal at screening
- •Clinically significant abnormal vital signs prior to initial administration of IMP as defined by:
- •Systolic blood pressure >160 or <90 mmHg
- •Diastolic blood pressure >90 or <60 mmHg
- •Pulse <55 or >105 bpm
- •Respiratory Rate (RR) <9 and >25 breaths per minute
- •Temperature >100.4 degrees Fahrenheit
- •History of cancer including melanoma (with the exception of localized skin cancers) within 5 years of study enrollment
- •Ulcerative colitis or indeterminate colitis
- •Suspicion or presence of an intraabdominal or perianal abscess
- •Microscopic, ischemic or infectious colitis
- •Neoplasia of the colon on preoperative biopsy
- •Evidence of colonic perforation
- •Colonic stricture that unable to pass an adult colonoscope
- •Three or more prior small bowel resections
- •Presence of an ostomy
- •Massive hemorrhage from the colon requiring emergent surgery in the 6 months prior to screening
- •Fulminant colitis requiring emergency surgery
- •Concurrent active clostridium difficile infection of the colon
- •Concurrent Cytomegalovirus infection of the colon via colonic biopsy with CMV stain taken within 90 days prior to screening
- •Active or latent tuberculosis
- •Unable to wean off corticosteroids
- •Primary sclerosing cholangitis
- •History of or current alcohol or drug abuse or dependence, recreational use of illicit drugs or prescription medications, or use of medical marijuana within 90 days prior to screening
- •Known allergy to local anesthetics
- •Concurrent use of anticoagulant medications (e.g. warfarin, heparin) or clopidogrel (Plavix)
- •History of known inherited or acquired hypercoagulable states.
- •Electrocardiogram demonstrating cardiac arrhythmia, except for sinus tachycardia within the predefined limit of no greater than 105 bpm.
- •Use of investigational therapy or treatment within 6 months prior to initial IMP administration
研究组 & 干预措施
DB-3Q 15 mL IV
Experimental
干预措施: DB-3Q (Biological)
DB-3Q 45 mL IV
Experimental
干预措施: DB-3Q (Biological)
DB-3Q 30 mL IV
Experimental
干预措施: DB-3Q (Biological)
Placebo IV
Placebo Comparator
干预措施: Placebo (Other)
研究者
研究点 (2)
Loading locations...
相似试验
招募中
2/3 期
A Study of Icotrokinra in Participants With Moderately to Severely Active Crohns DiseaseCTRI/2026/01/100471Johnson and Johnson Private Limited789
尚未招募
2/3 期
Ayurvedic Formulation and Lifestyle Changes for mild to moderate Crohn’s Disease: A Multicenter Clinical TrialCTRI/2025/06/088142Indian Council of Medical Research92
招募中
1 期
Clostridium Butyricum in Stenosing Crohn's DiseaseNCT07263880San Giovanni Addolorata Hospital40
招募中
2 期
A Study of Zasocitinib (TAK-279) in Adults With Active Crohn's DiseaseCrohn's DiseaseNCT07403968Takeda20
招募中
4 期
A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD)Crohn DiseaseNCT07310095Xian-Janssen Pharmaceutical Ltd.78