EUCTR2013-002857-32-HU进行中（未招募）不适用
Double-Blind, Randomized, Placebo-Controlled, Multi Centre Study to Investigate the Efficacy and Safety of GLPG0634 in Subjects With Active Crohn’s Disease With Evidence of Mucosal Ulceration
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Galapagos NV
- 入组人数
- 180
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 or female subjects between the ages of 18 and 75 years, on the day of signing informed consent.
- •2. Documented history of ileal, colonic, or ileocolonic CD (at least 3 months prior screening) as assessed by colonoscopy, and supported by histological assessment.
- •3. Crohn’s Disease Activity Index (CDAI) score during screening = 220 to = 450.
- •4. Evidence of active inflammation at screening as demonstrated by endoscopic confirmation of active disease (based on central reading) with evidence of ulceration corresponding to a score of 1 in at least 1 of the 5 ileocolonic segments on the Presence Ulcers subscore of the Simplified Endoscopy Score for CD (SES CD) and total score (excluding narrowing sub score) of at least 7.
- •5. Treatment with oral steroids (= 30 mg prednisolone equivalent/day or budesonide dose =9mg/day) is allowed, if at a stable dose since at least 2 weeks prior to the first dose of study drug.
- •6. Subjects previously not exposed to anti-TNF treatment (eg, TNF-naïve) or subjects previously exposed to anti-TNF therapy (eg, a single course of anti-TNF therapy with agents such as infliximab, adalimumab or certolizumab pegol) at a dose registered for the treatment of CD that has been discontinued at least 8 weeks prior to Baseline. Subjects deemed by the treating physician as a primary or secondary non-responder or intolerant to anti-TNF treatment or responders to anto-TNF treatmen, where treatment was stopped for other reason (TNF-experienced) can also be included.
- •7. Subjects are allowed to continue on concurrent treatment with the following agents:
- •a) Mesalazine and olsalazine if stable dosage for at least 4 weeks prior to Screening (same dosage to be maintained throughout the study). Previous exposure to sulfasalazine is permitted but must be discontinued at least 4 weeks prior to Screening.
- •b) Crohn’s Disease-related antibiotics if stable dosage for at least 4 weeks prior to Screening and no discontinuation in the 14 days prior to the first dose of study drug
- •c) Probiotics if stable dosage for 2 weeks prior to the first dose of study drug.
- •8. Previous exposure to immunomodulators (eg, thiopurines and methotrexate) is permitted, but must be discontinued at least 4 weeks prior to Screening. Documented evidence for the reasons of discontinuation should be provided.
- •9. The results of the following laboratory tests at screening must be as specified below:
- •a) Haemoglobin = 9 g/dL (International System of Units [SI]: = 90 g/L)
- •b) White blood cells (WBCs) = 3.0 x 109 cells/L
- •c) Neutrophils = 2.0 x 109 cells/L
- •d) Lymphocytes = 0.5 x 109 cells/L
- •e) Platelets = 100 x 109 cells/L
- •f) Serum alanine transaminase (ALT) and aspartate transaminase (AST) = 1.5 x ULN
- •g) Total bilirubin level = 1.5 x ULN
- •h) Alkaline phosphatase =1.5 x ULN
- •i) Lipase = 1.5 x ULN and amylase = 1.5 x ULN
- •j) Creatinine clearance > 60 mL/min and blood urea nitrogen (BUN) within normal ranges. Creatinine clearance will be calculated using the Cockroft-Gault formula.
- •10. Women of childbearing potential must have a negative blood pregnancy test, unless they are surgically sterile, had a hysterectomy, or have been postmenopausal for at least 1 year (12 consecutive months without menses); in case of doubt a determination of serum follicle-stimulating hormone (FSH) can be done with FSH levels > 35 mIU/mL confirming menopause status.
- •11. Subjects willing to use highly effective contraceptive methods prior to the first dose of the study
排除标准
- •1. Diagnosis of indeterminate colitis, ulcerative colitis (UC), or clinical findings suggestive of UC.
- •2. Stoma, gastric or ileanal pouch, proctocolectomy or total colectomy, symptomatic stenosis or obstructive strictures, abscess or suspected abscess, history of bowel perforation.
- •3. Subject who has had surgical bowel resections within the past 6 months or is planning any resection at any time point while enrolled in the study.
- •4. Subject who has short bowel syndrome.
- •5. Subject who is receiving tube feeding, defined formula diets, or total parenteral alimentation.
- •6. Subject with positive Clostridium difficile toxin stool assay or evidence of any other gastrointestinal infection (GI) (bacterial, viral, or parasitic) during the screening period.
- •7. Subject has received nonsteroidal anti-inflammatory drugs within 14 days prior to Screening.
- •8. Subject has received therapeutic enema or suppository, other than required for colonoscopy, within 7 days prior to and during screening period.
- •9. Subject has received intravenous corticosteroids within 14 days prior to Screening or during screening period.
- •10. If nonsystemic steroids are being used for other conditions than CD, subjects may be included at the discretion of the Investigator after discussion with the Medical Monitor.
- •11. Treatment with cyclosporine, mycophenolate mofetil, tacrolimus, or interferon within 10 weeks prior to Screening or during screening period.
- •12. Any prior treatment with lymphocyte-depleting agents. 13. Subjects who received treatment with more than one anti-TNF agent.
- •14. Subjects who have previously received fecal microbiota transplants or stem cell transplantation.
- •15. Subjects who have received previous treatment with investigational chemical agents withinless than 5 half-lives prior to Baseline. Previous treatment with a janus kinase inhibitor is prohibited.
- •16. Known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug as determined by the Investigator, such as anaphylaxis requiring hospitalization
- •17. Subject with a previous history of dysplasia of the gastrointestinal tract or found to have above described dysplasia in any biopsy performed during the Screening colonoscopy.
- •18. Concurrent gastro-intestinal (GI) malignancy or a history of cancer elsewhere (other than basal cell carcinoma or carcinoma in situ of the cervix successfully treated more than 5 years prior to the initial study drug administration).
- •19. History of lymphoproliferative disease; or signs and symptoms suggestive of possible lymphoproliferative disease including lymphadenopathy or splenomegaly
- •20. Positive serology for human immunodeficiency virus (HIV) 1 or 2 or hepatitis B or C, or any history of HIV or hepatitis from any cause with the exception of hepatitis A.
- •21. Known active infection of any kind or any major episode of infection requiring hospitalization or treatment with parenteral anti-infectives within 4 weeks of the Screening visit or completion of oral anti-infectives within 2 weeks of the Screening visit Immunocompromised subjects who in the opinion of the investigator are at an unacceptable risk for participating in the study.
- •22. Previous history of symptomatic herpes zoster or herpes simplex infection within 12 weeks prior to Screening or have a history of disseminated/complicated herpes zoster infection
- •23.History of invasive infection
- •24.Significant blood loss (> 500 mL) or transfusion of any blood produ
研究者
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