EUCTR2019-000824-17-HR进行中（未招募）1 期
A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn’s Disease
andos Biopharma Inc.0 个研究点目标入组 150 人开始时间: 2021年10月21日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
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
- •1. Male and female subjects aged 18 to 75 years, inclusive.
- •2. Diagnosis of CD for at least 3 months prior to screening.
- •3. Moderately to severely active CD as defined by all of the following:
- •a) CDAI score of 220-450.
- •b) SES-CD = 6 (= 4 for isolated ileitis) scored by a blinded central reader.
- •4. If subjects have previously received biologic therapy for CD (i.e., TNF-antagonists, vedolizumab, natalizumab, or ustekinumab), they must have a washout period of 8 weeks prior to randomization (or within 4 weeks prior to randomization, if no detectable drug levels confirmed by validated or commercial assay), and any previous failure (i.e., primary or secondary nonresponse) to biologic treatment is limited to only 1 class of biologic; prior exposure to biologics that have been discontinued for reasons other than nonresponse will not be limited. (Note: this inclusion criterion is only applicable until 75 subjects with prior exposure to biologic therapy have been randomized).
- •5. If subjects are receiving the following CD treatments, they must be on a stable dose for at least 1 month prior to randomization: 5-aminosalicylates (5-ASAs) (not exceeding 4.8 g per day) or oral corticosteroids (not exceeding prednisone 20 mg/day, budesonide 9 mg/day, or equivalent).
- •6. If subjects are receiving bile-salt sequestrant, they must be on a stable dose for at least 3 months prior to randomization.
- •7. If subjects are receiving any nonprohibited medications, they must agree to maintain stable doses of concomitant medications for CD for the duration of the trial.
- •8. Unlikely to conceive, as defined by 1 of the following: a) subject is a surgically sterilized female, b) subject is a postmenopausal female = 45 years of age with clinical documentation of menopause (i.e., 12 months without menses), or c) subject is male or is a woman of childbearing potential (WOCBP), and agrees to abstain from heterosexual activity, use adequate hormonal contraception, or use double-barrier contraception for 2 weeks after the last study drug administration.
- •9. For WOCBP, subject must have a negative pregnancy test at screening and within 24 hours prior to the first dose of study medication.
- •10. Able to participate fully in all aspects of this clinical trial.
- •11. Written informed consent must be obtained and documented.
- •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 135
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •1. A diagnosis of UC.
- •2. At imminent risk of ileocolectomy.
- •3. Subjects with known current complications of CD defined as any of the following:
- •a) Symptomatic bowel stricture.
- •b) Ostomy or ileoanal pouch.
- •c) Impassable anal or rectal stenoses.
- •d) Short gut syndrome.
- •e) Other complications that might require surgery, or any other manifestation that precludes or confounds the assessment of response to therapy (CDAI and endoscopic evaluation).
- •4. Any recent (within 2 months) abscess, unless it has been drained and treated at least 6 weeks prior to randomization and are not anticipated to require surgery. Subjects with nondraining perianal fistulas may be included provided there is no anticipated need for surgery and there are currently no abscesses present.
- •5. Any history of bowel resection or diversion within 3 months prior to screening.
- •6. Treatment with total parenteral nutrition within 2 weeks of screening.
- •7. Treatment with an immunosuppressant (azathioprine, 6-mercaptopurine [6-MP], methotrexate) within 25 days prior to randomization.
- •8. Treatment with efalizumab, or agents that deplete B or T cells (rituximab, alemtuzumab, or visilizumab) within 6 months of screening, or if after receiving these agents at any time prior to the study, evidence is available at screening of persistent depletion of the targeted lymphocyte population.
- •9. Regular daily use of opioids for medical reasons within 3 months prior to randomization.
- •10. Treatment with rectal 5-ASA compounds or intravenous or rectal corticosteroids within 4 weeks prior to randomization.
- •11. Treatment with oral corticosteroids prednisone equivalent dose > 20 mg/day, or > 9 mg/day of budesonide, or any changes to dose within the 4 weeks prior to randomization.
- •12. Treatment with antibiotics for CD within 1 month prior to screening.
- •13. Treatment with any investigational or approved biologic for CD within 8 weeks prior to randomization (or within 4 weeks prior to randomization, if no detectable drug levels confirmed by validated or commercial assay).
- •14. Treatment with any investigational or approved nonbiologic therapies for CD within 4 weeks prior to randomization.
- •15. Use of apheresis (e.g., Adacolumn apheresis) = 2 weeks prior to screening.
- •16. Current bacterial or parasitic pathogenic enteric infection, including Clostridioides difficile, known infection with hepatitis B or C virus, known infection with human immunodeficiency virus, infection requiring hospitalization or intravenous antimicrobial therapy, or opportunistic infection within 6 months prior to screening, any infection requiring antimicrobial therapy within 2 weeks prior to screening, history of more than 1 episode of herpes zoster or any episode of disseminated zoster.
- •17. Any live bacterial or viral vaccination within 12 weeks prior to randomization. Patients must agree not to receive a live virus or bacterial vaccination during the study or up to 12 months after the last administration of study drug.
- •18. Bacille Calmette–Guérin vaccination within 12 months of screening.
- •19. Current or previous colonic dysplasia, with the exception of completely resected adenomatous polyps.
- •20. Fecal microbiota transplantation within 1 month prior to screening.
- •21. A concurrent clinically significant, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal, GI, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder.
- •22. Known primary or secondary immunodeficiency.
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