Condition: Moderately to Severely Active Crohn's Disease · Crohn Disease · Disease Crohn · Sponsor: Alimentiv Inc.
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). Qualified participants will be randomly assigned in a 1:1 ratio to one of 2 different target treatment groups. Group 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.
This description comes directly from the study's public registry record.
Elena van Hest · 31205630316 · elena.vanhest@alimentiv.com
Always discuss trial participation with your own doctor first.
| TLC Clinical Research Inc - Los Angeles | Los Angeles, California, United States | Withdrawn |
| Medical University of South Carolina (MUSC) | Charleston, South Carolina, United States | Not Yet Recruiting |
| Houston Methodist Hospital | Houston, Texas, United States | Recruiting |
| Concord Repatriation General Hospital | Concord, New South Wales, Australia | Recruiting |
| Mater Misericordiae Ltd | South Brisbane, Queensland, Australia | Recruiting |
| Calvary Adelaide Hospital | Adelaide, South Australia, Australia | Recruiting |
| Royal Adelaide Hospital | Adelaide, South Australia, Australia | Recruiting |
| The Queen Elizabeth Hospital | Woodville, South Australia, Australia | Recruiting |
| Northern Hospital Epping | Epping, Victoria, Australia | Recruiting |
| Austin Health | Heidelberg, Victoria, Australia | Recruiting |
| The Alfred Hospital | Melbourne, Victoria, Australia | Recruiting |
| Royal Melbourne Hospital | Melbourne, Victoria, Australia | Recruiting |
+ 57 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06257706