VECTORS – A study to evaluate transmural healing as a treatment target in Crohn’s disease

Phase 1

Recruiting

• Conditions: Moderately to Severely Active Crohn’s Disease; MedDRA version: 20.0Level: PTClassification code: 10011401Term: Crohn's disease Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: CTIS2023-509096-16-00
• Lead Sponsor: Alimentiv Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-15
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 266

Inclusion Criteria

Adults aged 18 to 80 years, inclusive, at the time of consent;, 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);, CRP of =5 mg/L and/or FCal =250 µg/g at Screening;, BWT on IUS of >4.0 mm in the ileum or any colonic segment (excluding the rectum);, 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;, Participants may continue stable dose (initiated at least 4 weeks prior to Screening) of 5-ASA for CD;, 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;, Able to participate fully in all aspects of this clinical trial;, Written informed consent must be obtained and documented

Exclusion Criteria

Current or previous treatment with vedolizumab, etrolizumab, or natalizumab;, Abscess >2 cm, detected incidentally by IUS, but participants with draining fistulas are not excluded;, 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;, Positive stool test for Clostridioides difficile infection (as demonstrated by positive toxin);, 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;, 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;, Other systemic or opportunistic infection (including cytomegalovirus), any other clinically significant extraintestinal infection, or recurring infection within 6 months of randomization;, Has active cerebral/meningeal disease, signs, symptoms, or any history of progressive multifocal leukoencephalopathy (PML) prior to randomization;, Hypersensitivity, allergy, or intolerance to any excipient of vedolizumab or any other contraindication to vedolizumab;, Active severe infection such as sepsis, cytomegalovirus, listeriosis, or opportunistic infection., Unwillingness to withhold protocol-prohibited medications during the trial;, Previously exposed to 2 or more compounds of an advanced therapeutic compound (approved biologic or small molecule drug) for the treatment of their CD;, 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;, 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;, Prior enrolment in the current study and had received study treatment;, 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;, 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;, 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;, 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)., 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;, Only have inflammation proximal to the terminal ileum that cannot be reached by ileocolonoscopy;, Have a CD complication, such as symptomatic strictures in the small bowel with >3 cm prestenotic dilatation on any imaging modality, requiring procedural intervention;, 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, Ostomy or ileoanal pouch;, Short bowel syndrome;, Fibrotic-on

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified