Crohn Disease · Disease Crohn · Moderately to Severely Active Crohn's Disease
Targeting Transmural Healing in Adults With Active Crohn's Disease
This study asks whether adding intestinal-ultrasound targets to symptom and biomarker targets during vedolizumab treatment improves corticosteroid-free endoscopic remission in adults with moderately to severely active Crohn's disease.
Registry title: VECTORS - A Study to Evaluate Transmural Healing as a Treatment Target in Crohn's Disease
2 recruiting U.S. sites ↓Study at a glance
- Age
- 18 Years–80 Years
- Treatment
- Vedolizumab
- Design
- Randomized
- Central study contact
- Elena van Hest31205630316elena.vanhest@alimentiv.com
- Sponsor
- Alimentiv Inc.
Research question
Does treating toward intestinal-ultrasound outcomes, clinical remission, and biomarker remission produce more corticosteroid-free endoscopic remission than treating toward clinical and biomarker remission alone?
Participant snapshot
Who the study is looking for
- The study is looking for adults aged 18 through 80.
- The study is looking for people with moderately to severely active Crohn's disease confirmed by specified symptom and endoscopy scores.
- The study is looking for people with bowel-wall thickness greater than 4.0 mm in a specified ileal or colonic segment on intestinal ultrasound.
- Participants must be biologic-naive or have used no more than one approved advanced Crohn's therapy within the five years before screening.
- The study is being conducted at multiple international sites, but each site's current availability varies.
Participation overview
What participation may involve
Participants receive intravenous vedolizumab and undergo target assessments that may guide treatment changes. Group 1 adds intestinal-ultrasound targets; Group 2 uses clinical and biomarker targets. What participation may involve: - Receive vedolizumab by intravenous infusion at specified induction and maintenance timepoints. - Undergo clinical-symptom and biomarker assessments used as treatment targets in both groups. - Undergo intestinal ultrasound assessments; ultrasound results are an additional treatment target in Group 1. - Undergo endoscopic assessment for the primary outcome at Week 48. - Complete symptom diaries and patient-reported questionnaires at reported follow-up timepoints. The treatment-target period lasts 48 weeks, while several follow-up outcomes are assessed through Week 96.
Study interventions
What participants may receive or do
- Vedolizumab: All participants receive vedolizumab 300 mg by intravenous infusion at Weeks 0, 2, 6, and 10, then every eight weeks beginning at Week 14. Treatment may be modified at Weeks 22, 30, or 38 according to target assessments.
Study design
How the comparison works
This Phase 4, multicenter study assigns approximately 304 participants to one of two parallel treatment-target strategies; both groups receive vedolizumab over 48 weeks. Participants are randomly assigned 1:1. Assignment is stratified by recent advanced-therapy exposure, ileal versus colonic disease location, and disease duration of two years or less versus more than two years. Participants and investigators know the assigned target strategy. Central readers assessing intestinal ultrasound, endoscopy, and histology are blinded to assignment, participant, treatment received, and timepoint. The comparison group uses corticosteroid-free clinical-remission and biomarker-remission targets without the intestinal-ultrasound target used by Group 1. The registry lists no placebo or sham intervention; both groups receive vedolizumab.
Reported activities
Procedures and tests
- Intravenous vedolizumab infusions at Weeks 0, 2, 6, and 10, then every eight weeks beginning at Week 14.
- Intestinal ultrasound to measure bowel-wall thickness, color Doppler signal, ultrasound response, and transmural healing.
- Ileocolonoscopy and Simple Endoscopic Score for Crohn's Disease assessments used to evaluate endoscopic disease activity.
- Histology assessments scored by central readers to evaluate histologic remission and response.
- Blood testing for C-reactive protein and stool testing for fecal calprotectin.
- Crohn's Disease Activity Index assessments, including physical examination findings, hematocrit, extraintestinal manifestations, and diary-reported symptoms.
- Daily reporting of stool frequency and abdominal pain for seven days before specified clinic visits.
- Questionnaires covering Crohn's symptoms and impacts, bowel urgency, and inflammatory-bowel-disease-related quality of life.
- Screening may involve confirming pregnancy status and contraception requirements for people of childbearing potential.
- Screening may involve confirming infection-related criteria, including Clostridioides difficile, HIV, hepatitis B and C, and tuberculosis status.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must be 18 through 80 years old when they consent.
- Crohn's disease must be moderately to severely active at baseline, with a Crohn's Disease Activity Index score of 220 through 450 and the specified minimum endoscopy score.
- Intestinal ultrasound must show bowel-wall thickness greater than 4.0 mm in the terminal ileum or an eligible colonic segment.
- Participants must be biologic-naive or have used no more than one approved advanced Crohn's therapy within five years before screening.
- A stable dose of 5-aminosalicylic acid for Crohn's disease may continue if it began at least four weeks before screening.
- People who can become pregnant need a negative serum pregnancy test before randomization and must use highly effective contraception throughout the study.
- Participants must be able to take part fully in all aspects of the trial.
- Written informed consent must be obtained and documented.
Possible reasons someone may not be able to join
- Previous or current treatment with vedolizumab, etrolizumab, or natalizumab excludes participation.
- Previous exposure to two or more advanced Crohn's therapy compounds or classes excludes participation.
- An oral corticosteroid dose change within two weeks before randomization, or more than 40 mg prednisone-equivalent at randomization, excludes participation.
- People whose inflammation is only above the terminal ileum and cannot be reached by ileocolonoscopy are excluded.
- Certain Crohn's complications requiring a procedure, including symptomatic small-bowel strictures with more than 3 cm of prestenotic dilation, exclude participation.
- Specified bowel surgeries or anatomy—including extensive colon resection, an ostomy, an ileoanal pouch, or short-bowel syndrome—exclude participation.
- An abscess larger than 2 cm detected by intestinal ultrasound or endoscopy excludes participation; draining fistulas alone do not.
- Specified active, latent, recent, or recurring infections—including positive toxin-confirmed Clostridioides difficile, HIV, hepatitis B or C, and tuberculosis—exclude participation.
- Pregnancy, breastfeeding, specified pregnancy intentions, or planned egg or sperm donation during the stated period exclude participation.
- A live or live-attenuated vaccine within four weeks before randomization, or one planned during the study, excludes participation.
Important unknowns
What the record does not make clear
- The record lists many treatment and outcome timepoints but does not provide a complete visit calendar or identify which activities occur at every visit.
- Stable 5-aminosalicylic acid may continue, corticosteroid limits are stated, and protocol-prohibited medications are mentioned, but the full rules for other Crohn's treatments are not reported.
- Some medication timing restrictions are stated, but the record does not provide a complete washout schedule for all prior or current therapies.
- Rescue therapy is included in the definition of a Crohn's-related complication, but the record does not clearly describe when rescue treatment is available or how it affects continued participation.
- Endoscopy findings are required at baseline and used for the Week 48 primary outcome, but the complete endoscopy schedule, preparation, sedation, and biopsy requirements are not reported.
- The record does not state which study-related or routine-care costs are covered or billed to insurance.
- The record does not report whether participants receive compensation.
- The record does not report reimbursement or support for transportation, lodging, meals, or other travel needs.
- The record does not state whether any visits or assessments may be completed remotely.
- The record does not describe access to vedolizumab or other treatment after study participation ends.
- The study is listed as recruiting overall, but individual sites have recruiting, not-yet-recruiting, and withdrawn statuses.
Before contacting the site
Questions for the study team
- What is the complete schedule of clinic visits, infusions, ultrasounds, endoscopies, laboratory tests, stool samples, and questionnaires?
- What findings at Weeks 22, 30, or 38 would cause vedolizumab treatment to be modified, and what modifications are possible?
- Which current Crohn's medicines can continue, and are any washout periods required before randomization?
- What happens if Crohn's symptoms worsen, and which rescue treatments are allowed?
- How many ileocolonoscopies and biopsies are required, and what preparation and sedation are used?
- Which study-related costs are covered, and are compensation or travel reimbursement available?
- Is my preferred site actively enrolling, and can any follow-up activities be completed remotely?
- What treatment and clinical follow-up are offered after Week 96?
Before changing care
Questions for your gastroenterologist
- How would the study's vedolizumab schedule fit with my current Crohn's treatment plan?
- Would changing or withholding any of my current medicines create concerns about disease stability?
- What approved treatment alternatives should I compare with this trial's approach?
- Are there features of my Crohn's disease, prior surgery, infection history, or other conditions that make the study procedures or vedolizumab especially important to discuss?
- How should my regular gastroenterology care be coordinated with the research team during and after the study?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
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.
Study design and administration
- Organization
- Alimentiv Inc.
- Organization class
- Other
- Organization study ID
- TAK01769
- Lead sponsor
- Alimentiv Inc.
- Sponsor class
- Other
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- None
- Who is masked
- Not provided
- Standard age groups
- Adult, Older Adult
Study arms
Other
Group 1: Corticosteroid-free IUS-based outcomes + clinical remission + biomarker remission
Group 1 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.
Interventions: Biological: Vedolizumab
Other
Group 2: Corticosteroid-free clinical remission + biomarker remission.
Group 2 will be treated over 48 weeks to achieve a target of corticosteroid-free clinical remission + biomarker remission.
Interventions: Biological: Vedolizumab
Interventions
Biological
Vedolizumab
All participants will begin a vedolizumab induction regimen of 300 mg IV at Weeks 0, 2, 6, and 10 followed by vedolizumab 300 mg IV every 8 weeks starting at Week 14. Treatment may be modified at Weeks 22, 30, and/or 38 based on the results of the target assessment at each of these time points.
Eligibility
18 Years–80 Years
All
Not accepted
Inclusion criteria (8)
- Adults aged 18 to 80 years, inclusive, at the time of consent;Registry-derived · unreviewed
- 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);Registry-derived · unreviewed
- 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;Registry-derived · unreviewed
- 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;Registry-derived · unreviewed
- Participants may continue stable dose (initiated at least 4 weeks prior to Screening) of 5-ASA for CD;Registry-derived · unreviewed
- 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;Registry-derived · unreviewed
- Able to participate fully in all aspects of this clinical trial;Registry-derived · unreviewed
- Written informed consent must be obtained and documented.Registry-derived · unreviewed
Exclusion criteria (26)
- Current or previous treatment with vedolizumab, etrolizumab, or natalizumab;Registry-derived · unreviewed
- 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;Registry-derived · unreviewed
- 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;Registry-derived · unreviewed
- Only have inflammation proximal to the terminal ileum that cannot be reached by ileocolonoscopy;Registry-derived · unreviewed
- Have a CD complication, such as symptomatic strictures in the small bowel with \>3 cm prestenotic dilatation on any imaging modality, requiring procedural intervention;Registry-derived · unreviewed
- 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;Registry-derived · unreviewed
- Ostomy or ileoanal pouch;Registry-derived · unreviewed
- Short bowel syndrome;Registry-derived · unreviewed
- Fibrotic-only stricture in the ileum or colon without evidence of active inflammation (in the investigator's judgment), including any impassable stenosis;Registry-derived · unreviewed
- Abscess \>2 cm, detected by IUS or endoscopy; participants with draining fistulas are not excluded;Registry-derived · unreviewed
- 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;Registry-derived · unreviewed
- Positive stool test for Clostridioides difficile infection (as demonstrated by positive toxin);Registry-derived · unreviewed
- 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;Registry-derived · unreviewed
- 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;Registry-derived · unreviewed
- Other systemic or opportunistic infection (including cytomegalovirus), any other clinically significant extraintestinal infection, or recurring infection within 6 months of randomization;Registry-derived · unreviewed
- Has active cerebral/meningeal disease, signs, symptoms, or any history of progressive multifocal leukoencephalopathy (PML) prior to randomization;Registry-derived · unreviewed
- Hypersensitivity, allergy, or intolerance to any excipient of vedolizumab or any other contraindication to vedolizumab;Registry-derived · unreviewed
- Active severe infection such as sepsis, cytomegalovirus, listeriosis, or opportunistic infection.Registry-derived · unreviewed
- Unwillingness to withhold protocol-prohibited medications during the trial;Registry-derived · unreviewed
- Concurrent or previous participation in another clinical trial and received any investigational therapy within 30 days prior to randomization;Registry-derived · unreviewed
- 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;Registry-derived · unreviewed
- Prior enrolment in the current study and had received study treatment;Registry-derived · unreviewed
- 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;Registry-derived · unreviewed
- 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;Registry-derived · unreviewed
- 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;Registry-derived · unreviewed
- 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).Registry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Percentage of participants with Corticosteroid-free Endoscopic remission in group 1 and group 2 at week 48
Time frame: week 48
Corticosteroid-free is defined as not using corticosteroids at the time of the assessment. Endoscopic remission is defined by a total Simple Endoscopic Score for CD (SES-CD) ≤4 and at least a 2-point reduction versus baseline with no subscore greater than 1 in any individual variable. The SES-CD scores 4 endoscopic items (ulcer size, proportion of ulcerated surface, proportion of the surface area affected by any disease lesion, and stenosis) from 0 to 3, with higher scores representing more severe endoscopic disease activity. Each variable is scored for the 5 intestinal segments (ileum, right colon, transverse colon, left colon, and rectum) and summed to provide the total variable score. The sum of each variable score ranges from 0 to 15, except for stenosis (ranges from 0 to 11), because 3 represents a stenosis through which a colonoscope cannot be passed and therefore, can only be observed once. Total SES-CD score is then calculated by summing the item scores (range, 0-56 points).
Secondary outcome
Percentage of participants with Corticosteroid-free Transmural healing (TMH)+Endoscopic remission+Clinical remission in group 1 and group 2 at week 48
Time frame: week 48
Transmural healing is defined by Bowel wall thickness (BWT) ≤3.0 mm and color Doppler signal (CDS) 0 in all evaluable segments assessed by Intestinal Ultrasound. Endoscopic remission is defined by achievement of a total Simple Endoscopic Score for CD (SES-CD) ≤4 and at least a 2-point reduction versus baseline with no subscore greater than 1 in any individual variable. The SES-CD assesses 4 endoscopic variables: the size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each variable score ranging from 0 to 3. The total SES-CD score is calculated using the sum of all parameter scores in 5 segments: terminal ileum, right colon, transverse colon, left colon, and rectum. Clinical Remission is defined by achievement of Crohn's Disease Activity Index (CDAI) \<150. CDAI consists of eight factors, each summed after adjustment with a weighting factor. Total score ranges from 0 to 600 points. Higher scores indicate more severity.
Secondary outcome
Percentage of participants with Corticosteroid-free IUS response+Endoscopic remission+Clinical Remission in group 1 and group 2 at week 48
Time frame: week 48
IUS response is defined by reduction from baseline of 25% in Bowel Wall thickness (BWT) assessed by Intestinal Ultrasound (IUS). Endoscopic remission is defined by achievement of a total Simple Endoscopic Score for CD (SES-CD) ≤4 and at least a 2-point reduction versus baseline with no subscore greater than 1 in any individual variable. Clinical Remission is defined by achievement of Crohn's Disease Activity Index (CDAI) \<150. The CDAI consists of 8 items including physical examination items, extraintestinal manifestations, the hematocrit, and PRO measures as recorded in the participant diary card for the 7 days prior to the clinic visit. Each item is multiplied by a weighting factor and summed to give a total CDAI score, ranging from 0 to over 600 points, with higher scores representing more severe disease activity.
Secondary outcome
Percentage of participants with Corticosteroid-free Endoscopic remission+Clinical Remission in group 1 and group 2 at week 48
Time frame: week 48
Endoscopic remission is defined by achievement of a total Simple Endoscopic Score for CD (SES-CD) ≤4 and at least a 2-point reduction versus baseline with no subscore greater than 1 in any individual variable. The SES-CD scores 4 endoscopic items (ulcer size, proportion of ulcerated surface, proportion of the surface area affected by any disease lesion, and stenosis) from 0 to 3. Each variable is scored for the 5 intestinal segments (ileum, right colon, transverse colon, left colon, and rectum) and summed to provide the total variable score. Total SES-CD score is then summed up the item scores (range, 0-56 points). Clinical Remission is defined by Crohn's Disease Activity Index (CDAI) \<150. CDAI consists of eight factors, each summed after adjustment with a weighting factor. Total score ranges from 0 to 600 points. Higher scores indicate more severity.
Secondary outcome
Percentage of participants with Corticosteroid-free endoscopic response+Clinical response in group 1 and group 2 at week 48
Time frame: week 48
Endoscopic response is defined by Reduction in total Simple Endoscopic Score for CD (SES-CD) ≥50% from baseline. The SES-CD scores 4 endoscopic items (ulcer size, proportion of ulcerated surface, proportion of the surface area affected by any disease lesion, and stenosis) from 0 to 3, higher scores indicate more severity. Each variable is scored for the 5 intestinal segments (ileum, right colon, transverse colon, left colon, and rectum) and summed to provide the total variable score. The sum of each variable score ranges from 0 to 15, except for stenosis, where it ranges from 0 to 11. Total SES-CD score is then calculated by summing the item scores (range, 0-56 points). Clinical Response is defined by Crohn's Disease Activity Index (CDAI) decrease of ≥100 points from baseline. CDAI consists of eight factors, each summed after adjustment with a weighting factor. Total score ranges from 0 to 600 points. Higher scores indicate more severity.
Secondary outcome
Percentage of participants with Corticosteroid-free clinical remission in group 1 and group 2 at Week 14, Week 22 and Week 48.
Time frame: week 14, week 22 and week 48
Corticosteroid-free is defined as not using corticosteroids for treatment of CD at the time of the assessment. Clinical Remission is defined by achievement of Crohn's Disease Activity Index (CDAI) \<150. The CDAI consists of 8 items including physical examination items, extraintestinal manifestations, the hematocrit, and PRO measures as recorded in the participant diary card for the 7 days prior to the clinic visit. Each item is multiplied by a weighting factor and summed to give a total CDAI score, ranging from 0 to over 600 points, with higher scores representing more severe disease activity.
Secondary outcome
Percentage of participants with Corticosteroid-free Clinical Response in group 1 and group 2 at week 14, week 22 and week 48
Time frame: week 14, week 22 and week 48
Corticosteroid-free is defined as not using corticosteroids for treatment of CD at the time of the assessment. Clinical Response is defined by Crohn's Disease Activity Index (CDAI) decrease of ≥100 points from baseline. The CDAI consists of 8 items including physical examination items, extraintestinal manifestations, the hematocrit, and PRO measures as recorded in the participant diary card for the 7 days prior to the clinic visit. Each item is multiplied by a weighting factor and summed to give a total CDAI score, ranging from 0 to over 600 points, with higher scores representing more severe disease activity.
Secondary outcome
Crohn's Disease Activity Index(CDAI) total score and corresponding change from baseline during follow-up (Week 6, Week 14, Week 22, Week 30, Week 38, Week 48, Week 64, Week 80, Week 96) in group 1 and group 2
Time frame: week 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80, week 96
Crohn's Disease Activity Index (CDAI) consists of 8 items including physical examination items, extraintestinal manifestations, the hematocrit, and PRO measures as recorded in the participant diary card for the 7 days prior to the clinic visit. Each item is multiplied by a weighting factor and summed to give a total CDAI score, ranging from 0 to over 600 points, with higher scores representing more severe disease activity.
Secondary outcome
Percentage of participants with Corticosteroid-free endoscopic response in group 1 and group 2 at week 48
Time frame: week 48
Corticosteroid-free is defined as not using corticosteroids for treatment of CD at the time of the assessment Endoscopic response is defined by Reduction in total Simple Endoscopic Score for CD (SES-CD) ≥50% from baseline. The SES-CD scores 4 endoscopic items (ulcer size, proportion of ulcerated surface, proportion of the surface area affected by any disease lesion, and stenosis) from 0 to 3, with higher scores representing more severe endoscopic disease activity. Each variable is scored for the 5 intestinal segments (ileum, right colon, transverse colon, left colon, and rectum) and summed to provide the total variable score. The sum of each variable score ranges from 0 to 15, except for stenosis, where it ranges from 0 to 11, because 3 represents a stenosis through which a colonoscope cannot be passed and therefore, can only be observed once. Total SES-CD score is then calculated by summing the item scores (range, 0-56 points).
Secondary outcome
SES-CD total score and corresponding change from baseline to Week 48 in group 1 and group 2
Time frame: week 48
The SES-CD scores 4 endoscopic items (ulcer size, proportion of ulcerated surface, proportion of the surface area affected by any disease lesion, and stenosis) from 0 to 3, with higher scores representing more severe endoscopic disease activity. Each variable is scored for the 5 intestinal segments (ileum, right colon, transverse colon, left colon, and rectum) and summed to provide the total variable score. The sum of each variable score ranges from 0 to 15, except for stenosis, where it ranges from 0 to 11, because 3 represents a stenosis through which a colonoscope cannot be passed and therefore, can only be observed once. Total SES-CD score is then calculated by summing the item scores (range, 0-56 points).
Secondary outcome
Percentage of participants with Transmural healing (TMH) in group 1 and group 2 at week 48
Time frame: week 48
Transmural Healing (TMH) is defined by Bowel wall thickness (BWT) ≤3.0 mm and color Doppler signal (CDS) 0 in all evaluable segments assessed by Intestinal Ultrasound
Secondary outcome
Percentage of participants with Intestinal Ultrasound (IUS) response in group 1 and group 2 at Week 48
Time frame: week 48
IUS response is defined by reduction from baseline of 25% in Bowel Wall thickness (BWT) assessed by Intestinal Ultrasound (IUS)
Secondary outcome
Bowel Wall Thickness (BWT) measured by Intestinal Ultrasound (IUS) in mm and corresponding change from baseline at Week 48 in group 1 and group 2.
Time frame: week 48
Secondary outcome
Color Doppler signal (CDS) and corresponding change from baseline at Week 48 in group 1 and group 2.
Time frame: week 48
Secondary outcome
International Bowel Ultrasound Segmental Activity Score (IBUS-SAS) (per segment as well as total) and corresponding change from baseline at Week 48 in group 1 and group 2
Time frame: week 48
International Bowel Ultrasound Segmental Activity Score (IBUS-SAS) is a 0-100 numerical activity index for Crohn's disease calculated from four Intestinal Ultrasound (IUS) parameters
Secondary outcome
Percentage of participants with Transmural healing (TMH) at week 14, week 22, week 30, week 38, and week 48 in group 1
Time frame: week 14, week 22, week 30, week 38, week 48
Transmural Healing (TMH) is defined by Bowel wall thickness (BWT) ≤3.0 mm and color Doppler signal (CDS) 0 in all evaluable segments assessed by Intestinal Ultrasound
Secondary outcome
Percentage of participants with Intestinal Ultrasound (IUS) response at week 14, week 22, week 30, week 38, and week 48 in group 1
Time frame: week 14, week 22, week 30, week 38, week 48
IUS response is defined by reduction from baseline of 25% in Bowel Wall thickness (BWT) assessed by Intestinal Ultrasound (IUS)
Secondary outcome
Bowel Wall Thickness (BWT) measured by Intestinal Ultrasound (IUS) in mm and corresponding change from baseline at week 14, week 22, week 30, week 38, and week 48 in group 1
Time frame: week 14, week 22, week 30, week 38, week 48
Secondary outcome
Color Doppler signal (CDS) and corresponding change from baseline at week 14, week 22, week 30, week 38, and week 48 in group 1
Time frame: week 14, week 22, week 30, week 38, week 48
Secondary outcome
International Bowel Ultrasound Segmental Activity Score (IBUS-SAS) (per segment as well as total) and corresponding change from baseline at week 14, week 22, week 30, week 38, and week 48 in group 1
Time frame: week 14, week 22, week 30, week 38, week 48
International Bowel Ultrasound Segmental Activity Score (IBUS-SAS) is a 0-100 numerical activity index for Crohn's disease calculated from four Intestinal Ultrasound (IUS) parameters
Secondary outcome
Percentage of participants with Histologic remission at week 48 in group 1 and group 2
Time frame: week 48
Histologic remission is defined by Robarts Histopathology Index (RHI) score ≤3 (per segment) with subscores of 0 for lamina propria neutrophils and 0 for neutrophils in epithelium, as scored by central reader. The RHI is a validated instrument that measures histologic disease activity and consists of 4 subscores (chronic inflammatory infiltrate, lamina propria neutrophils, neutrophils in epithelium, and erosion or ulceration). Each subscore ranges from 0-3, with higher subscores indicating greater histologic disease activity. The RHI score is calculated as: (1 x chronic inflammatory infiltrate) + (2 x lamina propria neutrophils) + (3 x neutrophils in epithelium) + (5 x erosion or ulceration). The RHI therefore ranges from 0-33, with higher scores indicating greater histologic disease activity.
Secondary outcome
Percentage of participants with Histologic response at week 48 in group 1 and group 2
Time frame: week 48
Histologic response is defined as ≥7-point reduction from baseline in RHI, as scored by a central reader. The RHI is a validated instrument that measures histologic disease activity and consists of 4 subscores (chronic inflammatory infiltrate, lamina propria neutrophils, neutrophils in epithelium, and erosion or ulceration). Each subscore ranges from 0-3, with higher subscores indicating greater histologic disease activity. The RHI score is calculated as: (1 x chronic inflammatory infiltrate) + (2 x lamina propria neutrophils) + (3 x neutrophils in epithelium) + (5 x erosion or ulceration). The RHI therefore ranges from 0-33, with higher scores indicating greater histologic disease activity.
Secondary outcome
Percentage of patients with Biomarker remission at week 48, week 64, week 80 and week 96 in group 1 and group 2
Time frame: week 48, week 64, week 80, week 96
Biomarker remission is defined as Normalization of C-reactive protein (CRP) \<5 mg/mL and fecal calprotectin (FCal) \<250 μg/g
Secondary outcome
Percentage of patients with Biomarker response at week 48, week 64, week 80 and week 96 in group 1 and group 2
Time frame: week 48, week 64, week 80, week 96
Biomarker response is defined as ≥50% reduction from baseline in either C-reactive protein (CRP) or fecal calprotectin (FCal)
Secondary outcome
Percentage of participants with C-reactive protein (CRP) response during follow-up (Week 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80 and week 96) in group 1 and group 2
Time frame: week 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80, week 96
C-reactive protein (CRP) response is defined by ≥50% reduction from baseline
Secondary outcome
Percentage of participants with fecal calprotectin (FCal) response during follow-up (Week 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80 and week 96) in group 1 and group 2
Time frame: week 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80, week 96
Fecal calprotectin (FCal) response is defined by ≥50% reduction from baseline
Secondary outcome
Changes in C-reactive protein (CRP) from baseline during follow-up (Week 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80 and week 96) in group 1 and group 2
Time frame: week 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80, week 96
Secondary outcome
Changes in fecal calprotectin (FCal) from baseline during follow-up (Week 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80 and week 96) in group 1 and group 2
Time frame: week 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80, week 96
Secondary outcome
2-item Patient-Reported Outcome (PRO-2) score and corresponding changes from baseline during follow-up (Weeks 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80 and week 96) in group 1 and group 2
Time frame: week 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80, week 96
The PRO-2 consists of the 2 CDAI component items: daily stool frequency and abdominal pain. Study participants record the number of liquid or very soft stools and rate abdominal pain (range, 0-3) daily in their participant diary for the 7 days prior to a clinic visit, excluding days of bowel preparation and ileocolonoscopy. The stool frequency and abdominal pain scores are calculated as the average scores over the 7-day period.
Secondary outcome
Symptoms and Impacts Questionnaire for CD (SIQ-CD) score and corresponding changes from baseline during follow-up (Weeks 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80 and week 96) in group 1 and group 2
Time frame: week 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80, week 96
SIQ-CD tool consists of a symptom domain, which includes Gastrointestinal (GI), pain and discomfort, nutrition-related, and fatigue-related symptoms; and an impact domain, which includes concepts related to daily activities, nutrition, emotional well-being, and productivity.
Secondary outcome
Urgency Numerical Rating Score (NRS) and corresponding changes from baseline during follow-up (Weeks 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80 and week 96) in group 1 and group 2
Time frame: week 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80, week 96
The Urgency NRS evaluates the participant's sense of urgency to have a bowel movement over the previous 24 hours and is rated on an 11-point Likert scale, from 0 for "no urgency" to 10 for "worst possible urgency"
Secondary outcome
Inflammatory Bowel Disease Questionnaire (IBDQ) score and corresponding changes from baseline during follow-up (Weeks 30, week 48 and week 96) in group 1 and group 2
Time frame: week 30, week 48, week 96
The IBDQ measures health related quality of life in subjects with inflammatory bowel disease. It consists of 32 questions each with a graded response of 1 (worst) to 7 (best). The score ranges from 32 to 224
Secondary outcome
Time to CD-related complication from randomization through Week 96 in group 1 and group 2
Time frame: from randomization through Week 96
CD-related complication will be defined as any of the following: (1) CD-related surgery; (2) CD-related hospitalization; (3) CD medication-related complication; (4) CD procedure-related complication; (5) Rescue therapy for a documented CD-related flare e.g., new initiation of an advanced therapy other than VDZ (approved biologic or small molecule), dose escalation of vedolizumab, or dose intensification beyond the dose used at randomization of a corticosteroid after Week 48 or; (6) Other CD-related complication
Secondary outcome
Time to each component of CD-related complication in group 1 and group 2
Time frame: from randomization through Week 96
Secondary outcome
Percentage of participants who switched to an alternate biologic (yes/no) by Week 48 and Week 96
Time frame: week 48, week 96
Secondary outcome
Exposure-adjusted incidence rates of serious adverse events (SAEs), all adverse events (AEs), and AEs of special interest (AESIs) in group 1 and group 2
Time frame: up to week 96
Defined as the number of participants experiencing the event per 100 person-years (PYs) of exposure.
Recruiting locations in the United States
Medical University of South Carolina (MUSC)
Not Yet RecruitingCharleston, South Carolina, 29425, United States
Erin Forster, MD
Houston Methodist Hospital
RecruitingHouston, Texas, 77030, United States
Bincy Abraham, MD
This study also lists 66 locations outside the United States. They are not shown here.
Central study contacts
Registry dates
- First posted
- Feb 14, 2024
- Primary completion
- Jan 3, 2029
- Overall completion
- Feb 6, 2029
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.