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Evaluating Transmural Healing in Crohn's Disease Treatment

An Interventional Study to Evaluate Treating to a Target of Transmural Healing in Patients With Moderately to Severely Active Crohn's Disease

Phase 4 Interventional Alimentiv Inc. · NCT06257706

This study is testing if a new way of treating Crohn's disease that uses noninvasive ultrasound to track healing can help patients stay off corticosteroids and feel better compared to standard treatment.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment304 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorAlimentiv Inc. Academic / other
Drugs / interventionsvedolizumab, etrolizumab, natalizumab, prednisone
Locations69 sites (Los Angeles, California and 68 other locations)
Trial IDNCT06257706 on ClinicalTrials.gov

What this trial studies

This study aims to assess the effectiveness of targeting transmural healing (TMH) in patients with moderately to severely active Crohn's disease. Participants will be randomly assigned to one of two treatment groups, with one group focusing on achieving corticosteroid-free outcomes based on noninvasive intestinal ultrasound (IUS) alongside clinical symptoms and biomarkers. The study will measure the success of this approach in achieving corticosteroid-free endoscopic remission compared to a standard treatment that focuses solely on clinical symptoms and biomarkers. The use of IUS is intended to provide a patient-friendly method for monitoring disease activity.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 80 with moderately to severely active Crohn's disease and specific clinical and biomarker criteria.

Not a fit: Patients with mild Crohn's disease or those who have previously been treated with multiple advanced therapeutic compounds may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved long-term outcomes for patients with Crohn's disease by achieving better disease management without the use of corticosteroids.

How similar studies have performed: Other studies have suggested that targeting transmural healing may improve outcomes in Crohn's disease, but this specific approach is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Adults aged 18 to 80 years, inclusive, at the time of consent;
2. 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);
3. 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;
4. 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;
5. Participants may continue stable dose (initiated at least 4 weeks prior to Screening) of 5-ASA for CD;
6. 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;
7. Able to participate fully in all aspects of this clinical trial;
8. Written informed consent must be obtained and documented.

Exclusion Criteria:

1. Current or previous treatment with vedolizumab, etrolizumab, or natalizumab;
2. 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;
3. 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;
4. Only have inflammation proximal to the terminal ileum that cannot be reached by ileocolonoscopy;
5. Have a CD complication, such as symptomatic strictures in the small bowel with \>3 cm prestenotic dilatation on any imaging modality, requiring procedural intervention;
6. 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;
7. Ostomy or ileoanal pouch;
8. Short bowel syndrome;
9. Fibrotic-only stricture in the ileum or colon without evidence of active inflammation (in the investigator's judgment), including any impassable stenosis;
10. Abscess \>2 cm, detected by IUS or endoscopy; participants with draining fistulas are not excluded;
11. 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;
12. Positive stool test for Clostridioides difficile infection (as demonstrated by positive toxin);
13. 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;
14. 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;
15. Other systemic or opportunistic infection (including cytomegalovirus), any other clinically significant extraintestinal infection, or recurring infection within 6 months of randomization;
16. Has active cerebral/meningeal disease, signs, symptoms, or any history of progressive multifocal leukoencephalopathy (PML) prior to randomization;
17. Hypersensitivity, allergy, or intolerance to any excipient of vedolizumab or any other contraindication to vedolizumab;
18. Active severe infection such as sepsis, cytomegalovirus, listeriosis, or opportunistic infection.
19. Unwillingness to withhold protocol-prohibited medications during the trial;
20. Concurrent or previous participation in another clinical trial and received any investigational therapy within 30 days prior to randomization;
21. 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;
22. Prior enrolment in the current study and had received study treatment;
23. Pregnant, lactating, or intending to become pregnant/impregnate a partner before, during, or within 18 weeks after the last dose; or intending to donate ova or sperm during such time period;
24. 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;
25. 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;
26. 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).

Where this trial is running

Los Angeles, California and 68 other locations

+19 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Moderately to Severely Active Crohn's DiseaseCrohn DiseaseDisease Crohn
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.