CTIS2023-508158-24-00招募中1 期
A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of 2 Active Dose Regimens of MORF-057 in Adults with Moderately to Severely Active Crohn’s Disease (GARNET) - MORF-057-203
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 210
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 female, 18 to 85 years of age, inclusive, at the time of signing the Informed Consent Form (ICF)., 7. If the participant has been receiving any of the non-prohibited medications for CD listed below, he/she must discontinue use at least 5 half-lives before study Day 1 or must agree to maintain stable doses of these concomitant medications starting from the time specified below until the end of the SFU Period, with the exception of tapering oral corticosteroid dose after completion of the Induction Period. a. Oral 5-aminosalicylates (not exceeding 4.8 g per day): at least 2 weeks prior to Screening ileocolonoscopy; b. Oral corticosteroids (not exceeding prednisone 30 mg/day, budesonide 9 mg/day, beclomethasone dipropionate 5 mg/day, methylprednisolone 24 mg/day, or equivalent): at least 2 weeks prior to Screening ileocolonoscopy; c. 6-Mercaptopurine (any stable dose): at least 4 weeks prior to Screening ileocolonoscopy; d. Azathioprine (any stable dose): at least 4 weeks prior to Screening ileocolonoscopy; e. Methotrexate (any stable dose): at least 4 weeks prior to Screening ileocolonoscopy., 8. In the opinion of the Investigator, the participant can fully participate in all aspects of this clinical study., 10. A participant is eligible to participate if he/she agrees to abide by the guidelines regarding contraception requirements: a. A male participant is eligible to participate if he agrees to the following during the study Treatment Period and for at least 90 days after receiving the last dose of MORF-057: • Agrees to abstain from heterosexual intercourse as his preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agrees to remain abstinent OR • Agrees to use a male condom, with female partner use of an additional highly effective contraceptive method with a failure rate of <1% per year when having sexual intercourse with a woman of childbearing potential who is not currently pregnant; b. A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: • Is a woman of non-childbearing potential OR • Is a woman of childbearing potential and agrees to use a contraceptive method that is highly effective with a failure rate of <1% per year during the study Treatment Period and for at least 28 days after receiving the last dose of MORF-057., 9. Has a body mass index (BMI) =18.0 at Screening., 11. For the study Treatment Period and at least 90 days after receiving the last dose of MORF-057, male participants must agree not to donate sperm. For the study Treatment Period and at least 28 days after receiving the last dose of MORF-057, female participants must agree not to donate eggs (ova, oocytes)., 12. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol., 2. Participant has had a diagnosis of CD supported by signs/symptoms, endoscopy, and histology for at least 3 months prior to Screening. Appropriate documentation of biopsy results consistent with the diagnosis of CD, in the assessment of the Investigator, must be available., 3. Moderately to severely active CD was confirmed during the Screening Period with the following criteria: a CDAI score of 220 to 450 inclusive with an SES-CD score of =6. If disease is isolated to the ileum, the requirement will be an SES-CD score =4., 4. Average daily stool score =4 points and/or an average daily abd
排除标准
- •1. Diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, or UC, or has clinical findings suggestive of UC., 18. Has a clinically significant abnormal ECG at Screening, including a QT interval corrected through use of Fridericia’s formula (QTcF) =450 ms for males and =470 ms for females., 19. Abnormal hematology (hemoglobin level, white blood cell [WBC] count, or platelet count) or coagulation results at Screening, as evidenced by the ranges provided below: a. Hemoglobin level <8.0 g/dL; b. Absolute WBC count <3.0x10^9/L; c. Absolute lymphocyte count <0.5x10^9/L or >5.5x10^9/L; d. Absolute neutrophil count <1.2x10^9/L; e. Platelet count <100x10^9/L or 1000x10^9/L; f. International normalized ratio >1.5., 10. Has positive findings on a progressive multifocal leukoencephalopathy (PML) subjective symptom checklist during Screening or prior to the administration of the first dose of study drug on study Day 1., 20. Clinically significant abnormal urinalysis results, as deemed by the Investigator or designee., 21. Abnormal organ function at Screening, as evidenced by the following: a. Alanine aminotransferase or aspartate aminotransferase >2.0 × upper limit of normal (ULN) b. Chronic kidney disease stages 4 and 5, defined as having a glomerular filtration rate <30 mL/min/1.73 m^2 as calculated using the Modification of Diet in Renal Disease (MDRD) equation (National Kidney Foundation), receiving dialysis, or being listed for or has received a renal transplant c. Total bilirubin =1.5×ULN unless the patient has documented diagnosis of Gilbert’s syndrome and other diseases that can present with hyperbilirubinemia have been ruled out., 22. History of active malignancy in the 5 years preceding study Day 1, except in cases of basal cell skin cancer, squamous cell skin cancer, or other in-situ malignancies that have been excised and resolved and the participant was deemed clear of cancer after appropriate follow-up. Participants with a history of malignancy or those at high risk for malignancy may only be enrolled after a consultation with the Medical Monitor., 11. Has a potentially active bacterial, viral, or parasitic pathogenic enteric infection, including Clostridioides difficile (C. difficile); has hepatitis B or C virus, or human immunodeficiency virus (HIV); had an infection requiring hospitalization or intravenous antimicrobial therapy, or an opportunistic infection within 3 months prior to Screening; had any infection requiring oral antimicrobial therapy within 2 weeks prior to Screening; or has a history of more than 1 episode of herpes zoster or any episode of disseminated herpes zoster infection., 12. Has active tuberculosis (TB), as evidenced by any of the following: a. A diagnostic test for TB performed within 30 days prior to Screening or during the Screening Period that is positive, as defined below: • Two consecutive positive interferon gamma release assay (IGRA) tests (e.g., QuantiFERON® or T-SPOT® TB tests) or 2 consecutive indeterminate IGRA tests OR • A purified protein derivative (PPD) skin test =5 mm b. A chest X-ray or imaging per local guidelines within 3 months prior to Screening where active or latent pulmonary TB cannot be excluded., 2. Crohn’s disease isolated to the oral cavity, stomach, duodenum, jejunum, or perianal region, without colonic or ileal involvement., 3. Extensive bowel resection (>100 cm), and/or more than 3 resections, and/or known diagnosis of short bowel synd
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