VECTORS - A Study to Evaluate Transmural Healing as a Treatment Target in Crohn's Disease

Launched by ALIMENTIV INC. · Feb 5, 2024

Keywords

ClinConnect Summary

The VECTORS clinical trial is studying a new approach to treating Crohn's disease, specifically focusing on a concept called transmural healing (TMH). This means the study aims to see if patients can achieve better long-term health outcomes by targeting not just their symptoms but also the healing of the entire intestinal wall using a non-invasive imaging technique called intestinal ultrasound (IUS). Participants will be divided into two groups: one group will focus on achieving a specific healing target along with symptom management, while the other group will only focus on symptom management.

To be eligible for this study, participants need to be adults aged 18 to 80 with moderately to severely active Crohn's disease. They should have specific signs of the disease and must not have had extensive prior treatments. Throughout the 48-week study, participants will receive treatments and will be monitored for improvements in their condition. It's important to note that this study is currently recruiting participants, and those interested should discuss it with their healthcare provider to see if they qualify.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Participants must meet all of the following criteria for enrolment into the study:
• • 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. CRP of ≥5 mg/L and/or FCal ≥250 μg/g at Screening;
• • 4. BWT on IUS of \>4.0 mm in the ileum or any colonic segment (excluding the rectum);
• • 5. Biologic-naïve or have previous exposure 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;
• • 6. Participants may continue stable dose (initiated at least 4 weeks prior to Screening) of 5-ASA for CD;
• • 7. 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;
• • 8. Able to participate fully in all aspects of this clinical trial;
• • 9. Written informed consent must be obtained and documented.
• Exclusion Criteria:
• Participants who exhibit any of the following conditions are to be excluded from the study:
• • 1. Current or previous treatment with vedolizumab, etrolizumab, or natalizumab;
• • 2. Previously exposed to 2 or more compounds 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 incidentally by IUS, but 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 or 5 half-lives (whichever is longer) 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).