Moderately to Severely Active Crohn's Disease study: Vedolizumab
Official title VECTORS - A Study to Evaluate Transmural Healing as a Treatment Target in Crohn's Disease
ClinicalTrials.gov ID: NCT06257706
What this study is testing
What is Vedolizumab?
Vedolizumab is an investigational medicine, given as an IV infusion (through a vein), being studied as a potential treatment for moderately to severely active crohn's disease.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to find out whether aiming for ultrasound‑measured healing, together with symptom and lab goals, works better than aiming for symptoms and labs alone.
- Who it's for
- Adults who have moderately to severely active Crohn’s disease and are not currently on steroids.
- What's involved
- Participants will be randomly placed in one of two treatment plans and will have regular doctor visits, blood tests, symptom checks, and non‑invasive intestinal ultrasound scans over about a year.
- Time commitment
- The trial lasts 48 weeks with visits and ultrasounds at several set times, including weeks 22, 30, and 38.
- Phase 4: studies an already-approved treatment
- Time commitment: about 48 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
- 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...
- Biologic-naïve or have previous exposure (within the last 5 years of the screening date) to no more than 1 advanced therapeutic compound (approved...
- Participants may continue stable dose (initiated at least 4 weeks prior to Screening) of 5-ASA for CD;
You likely can't join if
- Current or previous treatment with vedolizumab, etrolizumab, or natalizumab;
- Previously exposed to 2 or more compounds or classes of an advanced therapeutic compound (approved biologic or small molecule drug) for the treatment...
- Change to oral corticosteroid therapy dosing within 2 weeks prior to randomization or a corticosteroid dose of \>40 mg of prednisone or equivalent at...
- 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...
- Previous extensive colonic resection or missing \>2 segments out of 5 (terminal ileum, right colon, transverse colon, sigmoid and left colon, and...
See the full eligibility criteria
Who can join
- 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);
- 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;
- 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.
- 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.
- Able to participate fully in all aspects of this clinical trial;
- Written informed consent must be obtained and documented.
What rules you out
- Current or previous treatment with vedolizumab, etrolizumab, or natalizumab;
- 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;
- 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-only stricture in the ileum or colon without evidence of active inflammation (in the investigator's judgment), including any impassable stenosis;
- Abscess \>2 cm, detected by IUS or endoscopy; 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;
- Concurrent or previous participation in another clinical trial and received any investigational therapy within 30 days 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).
The study team makes the final eligibility decision.
Where it is enrolling
- Houston, Texas, United States
- Concord, New South Wales, Australia
- South Brisbane, Queensland, Australia
- Adelaide, South Australia, Australia
- Woodville, South Australia, Australia
- Epping, Victoria, Australia
- Heidelberg, Victoria, Australia
- Melbourne, Victoria, Australia
- Murdoch, Western Australia, Australia
- Sint-Niklaas, Antwerpen, Belgium
- Bonheiden, Antwerp, Belgium
- Ghent, East Flanders, Belgium
- Leuven, Flemish Brabant, Belgium
- Roeselare, West Flanders, Belgium
- Brussels, Belgium
- Calgary, Alberta, Canada
- Edmonton, Alberta, Canada
- Bridgewater, Nova Scotia, Canada
- London, Ontario, Canada
- Toronto, Ontario, Canada
+ 26 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 48 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Houston, Texas, United States; Concord, New South Wales, Australia; South Brisbane, Queensland, Australia; Adelaide, South Australia, Australia; Woodville, South Australia, Australia; Epping, Victoria, Australia and 40 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.