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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06257706




Registration number
NCT06257706
Ethics application status
Date submitted
24/01/2024
Date registered
14/02/2024
Date last updated
14/08/2024

Titles & IDs
Public title
VECTORS - A Study to Evaluate Transmural Healing as a Treatment Target in Crohn's Disease
Scientific title
An Interventional Study to Evaluate Treating to a Target of Transmural Healing in Patients With Moderately to Severely Active Crohn's Disease
Secondary ID [1] 0 0
TAK01769
Universal Trial Number (UTN)
Trial acronym
VECTORS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Moderately to Severely Active Crohn's Disease 0 0
Crohn Disease 0 0
Disease Crohn 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Vedolizumab

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.

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.


Treatment: Other: 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.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of participants with Corticosteroid-free Endoscopic remission in group 1 and group 2 at week 48
Timepoint [1] 0 0
week 48
Secondary outcome [1] 0 0
Percentage of participants with Corticosteroid-free Transmural healing (TMH)+Endoscopic remission+Clinical remission in group 1 and group 2 at week 48
Timepoint [1] 0 0
week 48
Secondary outcome [2] 0 0
Percentage of participants with Corticosteroid-free IUS response+Endoscopic remission+Clinical Remission in group 1 and group 2 at week 48
Timepoint [2] 0 0
week 48
Secondary outcome [3] 0 0
Percentage of participants with Corticosteroid-free Endoscopic remission+Clinical Remission in group 1 and group 2 at week 48
Timepoint [3] 0 0
week 48
Secondary outcome [4] 0 0
Percentage of participants with Corticosteroid-free endoscopic response+Clinical response in group 1 and group 2 at week 48
Timepoint [4] 0 0
week 48
Secondary outcome [5] 0 0
Percentage of participants with Corticosteroid-free clinical remission in group 1 and group 2 at Week 14, Week 22 and Week 48.
Timepoint [5] 0 0
week 14, week 22 and week 48
Secondary outcome [6] 0 0
Percentage of participants with Corticosteroid-free Clinical Response in group 1 and group 2 at week 14, week 22 and week 48
Timepoint [6] 0 0
week 14, week 22 and week 48
Secondary outcome [7] 0 0
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
Timepoint [7] 0 0
week 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80, week 96
Secondary outcome [8] 0 0
Percentage of participants with Corticosteroid-free endoscopic response in group 1 and group 2 at week 48
Timepoint [8] 0 0
week 48
Secondary outcome [9] 0 0
SES-CD total score and corresponding change from baseline to Week 48 in group 1 and group 2
Timepoint [9] 0 0
week 48
Secondary outcome [10] 0 0
Percentage of participants with Transmural healing (TMH) in group 1 and group 2 at week 48
Timepoint [10] 0 0
week 48
Secondary outcome [11] 0 0
Percentage of participants with Intestinal Ultrasound (IUS) response in group 1 and group 2 at Week 48
Timepoint [11] 0 0
week 48
Secondary outcome [12] 0 0
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.
Timepoint [12] 0 0
week 48
Secondary outcome [13] 0 0
Color Doppler signal (CDS) and corresponding change from baseline at Week 48 in group 1 and group 2.
Timepoint [13] 0 0
week 48
Secondary outcome [14] 0 0
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
Timepoint [14] 0 0
week 48
Secondary outcome [15] 0 0
Percentage of participants with Transmural healing (TMH) at week 14, week 22, week 30, week 38, and week 48 in group 1
Timepoint [15] 0 0
week 14, week 22, week 30, week 38, week 48
Secondary outcome [16] 0 0
Percentage of participants with Intestinal Ultrasound (IUS) response at week 14, week 22, week 30, week 38, and week 48 in group 1
Timepoint [16] 0 0
week 14, week 22, week 30, week 38, week 48
Secondary outcome [17] 0 0
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
Timepoint [17] 0 0
week 14, week 22, week 30, week 38, week 48
Secondary outcome [18] 0 0
Color Doppler signal (CDS) and corresponding change from baseline at week 14, week 22, week 30, week 38, and week 48 in group 1
Timepoint [18] 0 0
week 14, week 22, week 30, week 38, week 48
Secondary outcome [19] 0 0
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
Timepoint [19] 0 0
week 14, week 22, week 30, week 38, week 48
Secondary outcome [20] 0 0
Percentage of participants with Histologic remission at week 48 in group 1 and group 2
Timepoint [20] 0 0
week 48
Secondary outcome [21] 0 0
Percentage of participants with Histologic response at week 48 in group 1 and group 2
Timepoint [21] 0 0
week 48
Secondary outcome [22] 0 0
Percentage of patients with Biomarker remission at week 48, week 64, week 80 and week 96 in group 1 and group 2
Timepoint [22] 0 0
week 48, week 64, week 80, week 96
Secondary outcome [23] 0 0
Percentage of patients with Biomarker response at week 48, week 64, week 80 and week 96 in group 1 and group 2
Timepoint [23] 0 0
week 48, week 64, week 80, week 96
Secondary outcome [24] 0 0
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
Timepoint [24] 0 0
week 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80, week 96
Secondary outcome [25] 0 0
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
Timepoint [25] 0 0
week 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80, week 96
Secondary outcome [26] 0 0
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
Timepoint [26] 0 0
week 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80, week 96
Secondary outcome [27] 0 0
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
Timepoint [27] 0 0
week 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80, week 96
Secondary outcome [28] 0 0
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
Timepoint [28] 0 0
week 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80, week 96
Secondary outcome [29] 0 0
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
Timepoint [29] 0 0
week 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80, week 96
Secondary outcome [30] 0 0
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
Timepoint [30] 0 0
week 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80, week 96
Secondary outcome [31] 0 0
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
Timepoint [31] 0 0
week 30, week 48, week 96
Secondary outcome [32] 0 0
Time to CD-related complication from randomization through Week 96 in group 1 and group 2
Timepoint [32] 0 0
from randomization through Week 96
Secondary outcome [33] 0 0
Time to each component of CD-related complication in group 1 and group 2
Timepoint [33] 0 0
from randomization through Week 96
Secondary outcome [34] 0 0
Percentage of participants who switched to an alternate biologic (yes/no) by Week 48 and Week 96
Timepoint [34] 0 0
week 48, week 96
Secondary outcome [35] 0 0
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
Timepoint [35] 0 0
up to week 96

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/08/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
6/09/2028
Actual
Sample size
Target
304
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Mater Misericordiae Ltd - South Brisbane
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 0 0
Northern Hospital Epping - Epping
Recruitment hospital [4] 0 0
Austin Health - Heidelberg
Recruitment hospital [5] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [6] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [7] 0 0
South Metropolitan Health Service - Murdoch
Recruitment hospital [8] 0 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3076 - Epping
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment postcode(s) [6] 0 0
- Melbourne
Recruitment postcode(s) [7] 0 0
6150 - Murdoch
Recruitment postcode(s) [8] 0 0
5011 - Woodville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
Belgium
State/province [2] 0 0
Antwerpen
Country [3] 0 0
Belgium
State/province [3] 0 0
East Flanders
Country [4] 0 0
Canada
State/province [4] 0 0
Alberta
Country [5] 0 0
Canada
State/province [5] 0 0
Ontario
Country [6] 0 0
France
State/province [6] 0 0
Provence-Alpes-Cote d'Azur
Country [7] 0 0
Germany
State/province [7] 0 0
Schleswig-Holstein
Country [8] 0 0
Italy
State/province [8] 0 0
Foggia
Country [9] 0 0
Italy
State/province [9] 0 0
Lombardia
Country [10] 0 0
Italy
State/province [10] 0 0
Milan
Country [11] 0 0
Italy
State/province [11] 0 0
Rome
Country [12] 0 0
Netherlands
State/province [12] 0 0
Gelderland
Country [13] 0 0
Netherlands
State/province [13] 0 0
North Holland
Country [14] 0 0
Poland
State/province [14] 0 0
Gmina Leczna
Country [15] 0 0
Poland
State/province [15] 0 0
Greater Poland
Country [16] 0 0
Poland
State/province [16] 0 0
Kuyavian-Pomeranian
Country [17] 0 0
Poland
State/province [17] 0 0
Lower Silesian
Country [18] 0 0
Poland
State/province [18] 0 0
Masovia
Country [19] 0 0
Poland
State/province [19] 0 0
Podkarpackie
Country [20] 0 0
Poland
State/province [20] 0 0
Silesian
Country [21] 0 0
Poland
State/province [21] 0 0
West Pomerianian
Country [22] 0 0
Poland
State/province [22] 0 0
Wroclaw
Country [23] 0 0
United Kingdom
State/province [23] 0 0
East Midlands
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Harrow
Country [25] 0 0
United Kingdom
State/province [25] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
Alimentiv Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Takeda
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT06257706
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Vipul Jairath, MD
Address 0 0
Alimentiv Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Piotr Kolos
Address 0 0
Country 0 0
Phone 0 0
+48793500318
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06257706