[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"disease-crohn\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:disease-crohn":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100535890","phase-4-vectors---a-study-to-evaluate-transmural-healing-as-a-treatment-target-in-crohns-disease-100535890",false,"NCT06257706","VECTORS - A Study to Evaluate Transmural Healing as a Treatment Target in Crohn's Disease","An Interventional Study to Evaluate Treating to a Target of Transmural Healing in Patients With Moderately to Severely Active Crohn's Disease","VECTORS","Inclusion Criteria:\n\n1. Adults aged 18 to 80 years, inclusive, at the time of consent;\n2. Moderately to severely active CD at baseline defined by a CDAI score of 220 to 450 inclusive and SES-CD, excluding the presence of narrowing component, ≥6 (or ≥4 for participants with isolated ileal disease);\n3. BWT on IUS of \\>4.0 mm in the terminal ileum or any colonic segment (excluding the rectum) as assessed by the mean of 2 longitudinal and 2 cross-sectional measurements of the same segment;\n4. Biologic-naïve or have previous exposure (within the last 5 years of the screening date) to no more than 1 advanced therapeutic compound (approved biologic or small molecule drug) for the treatment of their CD. Note: only approximately 15% to 30% of the enrolled population will have had prior exposure to an advanced therapeutic;\n5. Participants may continue stable dose (initiated at least 4 weeks prior to Screening) of 5-ASA for CD;\n6. Persons of childbearing potential must have a negative serum pregnancy test prior to randomization and must use a highly effective method of contraception throughout the study. Females unable to bear children must have documentation of such in the source records;\n7. Able to participate fully in all aspects of this clinical trial;\n8. Written informed consent must be obtained and documented.\n\nExclusion Criteria:\n\n1. Current or previous treatment with vedolizumab, etrolizumab, or natalizumab;\n2. Previously exposed to 2 or more compounds or classes of an advanced therapeutic compound (approved biologic or small molecule drug) for the treatment of their CD;\n3. Change to oral corticosteroid therapy dosing within 2 weeks prior to randomization or a corticosteroid dose of \\>40 mg of prednisone or equivalent at randomization;\n4. Only have inflammation proximal to the terminal ileum that cannot be reached by ileocolonoscopy;\n5. Have a CD complication, such as symptomatic strictures in the small bowel with \\>3 cm prestenotic dilatation on any imaging modality, requiring procedural intervention;\n6. Previous extensive colonic resection or missing \\>2 segments out of 5 (terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum), ileorectal anastomosis, or a proctocolectomy;\n7. Ostomy or ileoanal pouch;\n8. Short bowel syndrome;\n9. Fibrotic-only stricture in the ileum or colon without evidence of active inflammation (in the investigator's judgment), including any impassable stenosis;\n10. Abscess \\>2 cm, detected by IUS or endoscopy; participants with draining fistulas are not excluded;\n11. Serious underlying disease other than CD that, in the opinion of the investigator, may interfere with the participant's ability to participate fully in the study or would compromise participant safety;\n12. Positive stool test for Clostridioides difficile infection (as demonstrated by positive toxin);\n13. Known HIV or hepatitis B or C infection. If a negative test result is available in the 12 months prior to randomization, retesting is not required;\n14. Known active or latent tuberculosis (TB); if a negative test result is available in the 12 months prior to randomization, confirmatory testing (per standard of care) is not required before randomization;\n15. Other systemic or opportunistic infection (including cytomegalovirus), any other clinically significant extraintestinal infection, or recurring infection within 6 months of randomization;\n16. Has active cerebral\u002Fmeningeal disease, signs, symptoms, or any history of progressive multifocal leukoencephalopathy (PML) prior to randomization;\n17. Hypersensitivity, allergy, or intolerance to any excipient of vedolizumab or any other contraindication to vedolizumab;\n18. Active severe infection such as sepsis, cytomegalovirus, listeriosis, or opportunistic infection.\n19. Unwillingness to withhold protocol-prohibited medications during the trial;\n20. Concurrent or previous participation in another clinical trial and received any investigational therapy within 30 days prior to randomization;\n21. History of alcohol or drug abuse that in the opinion of the investigator may interfere with the participant's ability to comply with the study procedures;\n22. Prior enrolment in the current study and had received study treatment;\n23. Pregnant, lactating, or intending to become pregnant\u002Fimpregnate a partner before, during, or within 18 weeks after the last dose; or intending to donate ova or sperm during such time period;\n24. Vaccination with a live or live-attenuated vaccine within 4 weeks prior to randomization, or planned vaccination with a live or live-attenuated vaccine during participation in the study;\n25. Any person performing mandatory military service, deprived of liberty, in a residential care setting, or any person who, due to a judicial decision, cannot take part in clinical studies;\n26. The person is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (e.g., spouse, parent, child, sibling).","ALL","18 Years","80 Years",{"count":21,"type":22},304,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","Transmural healing (TMH) is recognized as a potentially important measure of Crohn's disease (CD) activity but not a formal target. Observational studies suggest that TMH may be associated with better long-term outcomes. The study will evaluate TMH using noninvasive intestinal ultrasound (IUS), a patient-friendly technique that can be performed routinely in clinical practice. The aim of the study is to determine if treating to a target of corticosteroid-free (CS-free) IUS outcomes + clinical symptoms + biomarkers is superior to a target of clinical symptoms + biomarkers alone in achieving CS-free endoscopic remission measured by the Simple Endoscopic Score for Crohn's Disease (SES-CD).\n\nQualified participants will be randomly assigned in a 1:1 ratio to one of 2 different target treatment groups.\n\nGroup 1: Participants will be treated over 48 weeks to achieve a target of corticosteroid-free IUS-based outcomes + clinical remission + biomarker remission. At Week 22 and 30, the IUS-based component of the target will be IUS response and at Week 38, the final treatment target will be TMH. Group 2: Participants will be treated over 48 weeks to achieve a target of corticosteroid-free clinical remission + biomarker remission.",[28,29,30],"Moderately to Severely Active Crohn's Disease","Crohn Disease","Disease Crohn","RECRUITING","2026-01-14",{"date":34,"type":35},"2026-01-15","ACTUAL",{"date":37,"type":35},"2024-08-07",{"date":39,"type":22},"2029-02-06",{"name":41,"class":42},"Alimentiv Inc.","OTHER",69,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100520701","phase-3-induction-treatment-with-subcutaneous-infliximab-for-crohns-disease-100520701","NCT06059989","InDuctIon TREatment with SubCuTaneous Infliximab for Crohn's Disease","A Multicenter Randomized, Open-label Study to Compare the Efficacy of Subcutaneous Infliximab Monotherapy with Subcutaneous Infliximab and Concomitant Immunosuppression in the Treatment of Moderate to Severe Crohn's Disease","DIRECTCD","Inclusion Criteria:\n\n1. Patients 18 years or older diagnosed with Crohn's disease\n2. Patients with moderate to severely active Crohn's disease with a Crohn's Disease Activity Index (CDAI) of 250 to 450 and presence of endoscopic ulceration in the terminal ileum, colon or both. Minimal SES-CD is ≥ 6 or ≥ 4 for isolated ileal disease.\n3. Patients who had no response or loss of response to or have had intolerable side effects to one or more to the following: glucocorticoids, thiopurines (azathioprine\u002F6-mercaptopurine\u002F6-thioguanin), methotrexate , adalimumab, vedolizumab or ustekinumab OR patients in need of immediate top-down treatment with IFX at the discretion of the treating physician.\n4. In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements.\n5. The subject signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedure.\n6. Male or non-pregnant, non-lactating females. No wish to become pregnant in the coming 26 weeks.\n\nExclusion Criteria:\n\n1. Patients at imminent need of surgery as judged by the treating clinician\n2. Patients with the short bowel syndrome, an ostomy or a symptomatic non-inflammatory stricture\n3. Patients previously exposed to IFX (intravenous or subcutaneous)\n4. Previously unacceptable side effects or intolerance to all immunosuppressants (both thiopurines and methotrexate)\n5. Treatment with adalimumab or vedolizumab or ustekinumab within 30 days\n6. Patients who have had a primary non-response to adalimumab or had intolerable class-related side effects (as evaluated at the discretion of the treating physician)\n7. Enteric pathogens (such as Salmonella, Shigella, Yersinia, Campylobacter and C. difficile) detected by stool analysis within 2 weeks prior to enrollment or at screening\n8. Ongoing participation in another interventional trial\n9. Patients with Ulcerative Colitis or Inflammatory bowel disease unclassified (IBD-U)\n10. Patients with ongoing abdominal or undrained perianal abscess\n11. Patients with a history of colon cancer or colonic dysplasia, unless sporadic adenoma, which has been removed\n12. Active or latent tuberculosis (screening according to national guidelines). Except when the latter has been treated appropriately according to national guidelines.\n13. Cardiac failure in the New York heart Association (NYHA) stage III-IV\n14. History of demyelinating disease\n15. Recent live vaccination (≤ 4 weeks)\n16. Patients with ongoing acute\u002Fchronic infection (including but not limited to HIV, hepatitis B and C) with the exception of chronic herpes labialis or cervical human papillomavirus (HPV)\n17. History of cancer in the last 5 years with the exception of non-melanoma skin cancer\n18. Male patients with Epstein-Barr virus (EBV) negative serology\n19. A history of alcohol or illicit drug use that in the opinion of the principal investigator (PI) would interfere with study procedures\n20. Patients with psychiatric problems that in the opinion of the PI would interfere with study procedures\n21. Patients unable to attend all study visits\n22. Patients with a history of non-compliance with clinical study protocols\n23. Contraindication for endoscopy\n24. Patients who received any investigational drug in the past 30 days or 5 half-lives, whichever is longer\n25. Pregnancy or lactation or wish to become pregnant in the coming 26 weeks",{"count":53,"type":22},158,[55],"PHASE3","Study Design:\n\nA Prospective Multicenter Randomized Controlled, Open-label Non-inferiority Study to Investigate the Efficacy of Subcutaneous (SC) Infliximab (IFX) with and without Immunomodulators during Induction treatment in Moderate to Severe Crohn's Disease.\n\nPrimary endpoint:\n\nThe proportion of patients in corticosteroid-free clinical remission (as defined by a Crohn's disease activity index (CDAI)\\\u003C150) and endoscopic response (as defined by a simple endoscopic score for Crohn's disease (SES-CD) drop of at least 50%) at week 26.\n\nAccrual and feasibility:\n\nThis study will enroll 158 subjects at approximately 20 sites in the Netherlands (peripheral and academic hospitals). The estimated enrollment is 0.5 patient\u002Fcentre\u002Fmonth leading to an inclusion duration of 16 months once all centres are open. The first enrolment is anticipated in Q1 2021.\n\nTreatment, dosage and administration:\n\nEligible patients will be randomized to receive SC IFX monotherapy (240mg at week 0 and week 2 and then 120mg every other week (EOW) OR SC IFX (240mg at week 0 and week 2 and then 120mg EOW) in combination with immunosuppression.",[58,30,59],"Inflammatory Disease","Bowel Disease",[61,62,63],"Crohn's disease","Biological","Subcutaneous","2024-12-05",{"date":66,"type":35},"2024-12-10",{"date":68,"type":35},"2021-11-25",{"date":70,"type":22},"2025-12",{"name":72,"class":42},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)",1]