VOICE-Early Response to Vedolizumab and IL-23 Antagonists in Participants With Crohn's Disease: A Prospective Observational Study (VOICE)

February 11, 2026 updated by: Alimentiv Inc.

VOICE-Characterization of Early Response to Vedolizumab and IL-23 Antagonists in Participants With Crohn's Disease Using Patient-Reported Outcome Measures: A Prospective Observational Study

The primary aim of this study is to explore the time course of response to Vedolizumab in participants with CD as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference-short form (SF), as well as other PROMIS domain SFs (fatigue, anxiety, depression, sleep disturbance, physical function, and ability to participate in social roles and activities); other PRO measures will also be assessed.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Vedolizumab (VDZ), a monoclonal antibody that selectively targets intestinal T-cell trafficking, is an effective and safe treatment for moderately to severely active Crohn's disease (CD). Recent evidence from open-label, blinded endpoint studies such as VERSIFY and LOVE-CD provide further support for the efficacy of VDZ in achieving clinical, endoscopic, histologic and radiologic disease improvement in CD. Despite these data, VDZ is generally perceived to have a slower onset of action than other biologics, including tumor necrosis factor (TNF) antagonists and the interleukin (IL)-12/23 antagonist, ustekinumab (UST). The IL-23 antagonist risankizumab (RISA) has been more recently approved for treatment of CD and post-hoc analyses of SEQUENCE trial data showed RISA to be superior to UST for inducing clinical remission at Week 24, and thus, RISA may also be considered to have a quicker onset of action than VDZ. This perception largely emanates from the results of the VDZ pivotal for CD (GEMINI 2) where efficacy was assessed at Week 6 after only 2 doses in a largely refractory population. However, in clinical practice VDZ induction consists of 3 doses of VDZ 300 mg administered intravenously at weeks 0, 2 and 6 instead of the 2 doses used in the pivotal trials. In recent clinical trials, induction endpoints for therapeutics in CD are now typically measured at least after Week 12. Accordingly, it is uncertain whether the generally held perception of a relatively slow onset of action for VDZ is accurate. Moreover, it should also be noted that the perception of a slow onset of action has also been conflated to infer that VDZ is a relatively less effective induction therapy in CD than TNF antagonists or UST. Further data to evaluate these issues are needed.

Rapidity of symptom resolution, which is commonly used as a surrogate for speed of onset, is a priority for patients and clinicians. It is therefore important to better understand the kinetics of symptom improvement captured using patient-reported outcomes (PROs) in patients initiating VDZ for treatment of CD.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G2X8
        • Recruiting
        • University of Alberta
        • Contact:
        • Principal Investigator:
          • Dr. Hoentjen
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z2K5
        • Recruiting
        • University of British Columbia
        • Contact:
        • Principal Investigator:
          • Dr. Bressler
    • Ontario
      • Brampton, Ontario, Canada, L6S0E2
        • Recruiting
        • GNRR Digestive Clinics and Research Center
        • Contact:
        • Principal Investigator:
          • Dr. Bajaj
      • London, Ontario, Canada, N6A5A5
        • Recruiting
        • London Health Sciences Centre
        • Contact:
        • Principal Investigator:
          • Vipul Jairath, Dr.
      • London, Ontario, Canada, N6Z5B6
        • Recruiting
        • Alimentiv
        • Principal Investigator:
          • Rocio Sedano, Dr.
      • Mississauga, Ontario, Canada, L5M7N4
      • Oakville, Ontario, Canada, L6L4P7
        • Recruiting
        • Rajbir Rai Medicine Professional Corporation
        • Contact:
        • Principal Investigator:
          • Dr. Rai
      • Oakville, Ontario, Canada, L6L5L7
        • Recruiting
        • ABP Research Services Corp.
        • Contact:
        • Principal Investigator:
          • Dr. Arya
      • Ottawa, Ontario, Canada, K1H8L6
        • Recruiting
        • The Ottawa Hospital
        • Contact:
        • Principal Investigator:
          • Sanjay Murthy, Dr.
      • Scarborough Village, Ontario, Canada, M1B3V4
        • Recruiting
        • Scarborough Center for Inflammatory Bowel Disease
        • Contact:
        • Principal Investigator:
          • Dr. Reinglas
      • Toronto, Ontario, Canada, M6A3B4
        • Recruiting
        • Toronto Immune & Digestive Health Institute Inc.
        • Contact:
        • Principal Investigator:
          • Dr. Silverberg
    • Ontatrio
      • Hamilton, Ontatrio, Canada, L8N 3Z5
        • Recruiting
        • McMaster University Medical Center
        • Contact:
        • Principal Investigator:
          • Dr. Narula
    • Quebec
      • Montreal, Quebec, Canada, H3G1A4
        • Recruiting
        • Montreal General Hospital
        • Contact:
        • Principal Investigator:
          • Talat Bessissow, Dr.
  • United States
    • Arizona
      • Sun City, Arizona, United States, 85351
    • Florida
      • Kissimmee, Florida, United States, 34741
        • Withdrawn
        • Digestive and Liver Center of Florida
    • Illinois
      • Evanston, Illinois, United States, 60611
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa
        • Contact:
        • Principal Investigator:
          • Dr. Ashat
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • University Medical Center New Orleans
        • Contact:
        • Principal Investigator:
          • Dr. Loganantharaj
    • Massachusetts
      • Chestnut Hill, Massachusetts, United States, 02467
        • Recruiting
        • Brigham and Women's Hospital
        • Contact:
        • Principal Investigator:
          • Rahul Dalal, Dr
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • University of North Carolina
        • Contact:
        • Principal Investigator:
          • Dr. Long
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Foundation
        • Contact:
        • Principal Investigator:
          • Florian Rieder, Dr
    • Oregon
      • Portland, Oregon, United States, 97220
        • Recruiting
        • OR Clinic - East - GI
        • Contact:
        • Principal Investigator:
          • Dr. Kiyasu
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • GI Alliance Research Fort Worth
        • Contact:
        • Principal Investigator:
          • Dr. Gutta
      • Mansfield, Texas, United States, 76063
        • Recruiting
        • GI Alliance Research Mansfield
        • Contact:
        • Principal Investigator:
          • Dr. Odunsi-Shiyanbade
    • Washington
      • Bellevue, Washington, United States, 98004
        • Recruiting
        • GI Alliance - Bellevue - Washington Gastroenterology
        • Contact:
        • Principal Investigator:
          • Dr. Procaccini

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study will be conducted in US and Canadian participants with CD prescribed VDZ or IL-23 antagonists for the first time. Approximately 300 participants with CD who are initiating first-time treatment with VDZ or UIL-23 antagonists will be enrolled in this study.

Description

Inclusion Criteria:

  1. Participant is an adult 18 years of age or older with confirmed CD, as per standard clinical criteria which may include symptoms, endoscopy, histopathology, and imaging.
  2. Participant has active CD and has been prescribed as standard of care (SOC) and is planned to start VDZ or IL-23 antagonist therapy (UST, RISA, or GUS or MIR [if approved for the treatment of CD during the recruitment period for this study]) for the first time in accordance with the product label, as determined by the treating physician.

  3. Participant has a baseline PROMIS Pain Interference-SF score ≥ 15 (corresponding T-score ≥ 55) (PROMIS Pain Interference-SF 8a [V1.1]).

    a. Score is calculated by adding score (1 to 5) for each of the 8 subcomponents.

  4. Participant has completed all SOC biologic work-up assessments (this may include assessment of tuberculosis, chronic infections, Clostridioides difficile infection and vaccination status per local practice).
  5. Ability of participant to participate fully in all aspects of this observational study. Full comprehension of consent language and informed consent must be obtained from the participant and documented.

Exclusion Criteria:

  1. Participant has CD-related surgery planned or anticipated during the study.
  2. Participant has prior exposure to an advanced therapy for the treatment of CD (biologic or small molecule) other than an anti-TNF (i.e., anti-integrin, anti-IL, Janus kinase inhibitors, or sphingosine-1-phosphate receptor 1). Prior failure or intolerance to 2 or more anti-TNF (i.e., infliximab, adalimumab, or certolizumab pegol) therapies in the past 3 years is also cause for exclusion.

  3. Participant has an active infection at baseline requiring intravenous systemic antibiotics.

    Note: The treating physician must have completed all appropriate baseline screening tests as per the product label.

  4. Participant has evidence of C. difficile toxin or is prescribed treatment for C. difficile infection, or other intestinal bacterial pathogen, ≤ 2 weeks prior to Screening.
  5. Participant has chronic non-inflammatory bowel disease pain.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Vedolizumab

Group one will include participants who will be starting Vedolizumab as part of routine care.

Dose, frequency and duration are not mandated as part of the study and are determined by the health care provider.
Drug: Vedolizumab (VDZ)
Participants will receive VDZ as part of routine care.
Other Names:
  • Entyvio
IL-23 Antagonists

Group two will include participants who will be starting an IL-23 antagonist as part of routine care.

Dose, frequency and duration are not mandated as part of the study and are determined by the health care provider.
Drug: Ustekinumab (UST)
Participants will receive UST as part of routine care.
Other Names:
  • Stelara
Drug: Risankizumab (RISA)
Participants will receive RISA as part of routine care.
Other Names:
  • Skyrizi
Drug: Guselkumab (GUS)
Participants will receive GUS as part of routine care.
Other Names:
  • Tremfya
Drug: Mirikizumab (MIR)
Participants will receive MIR as part of routine care.
Other Names:
  • Omvoh

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess time of onset of biologic therapy in pain interference
Time Frame: Baseline to Week 14
Time to meaningful clinical improvement in pain interference, defined as a ≥ 2-point decrease in the PROMIS Pain Interference-SF T-score
Baseline to Week 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess time of onset of biologic therapy in multiple QOL and functioning domains
Time Frame: Baseline to Weeks 14, 30, and 52
Time to meaningful clinical improvement for each individual PROMIS domain, defined as a ≥ 2-point change in the direction of improvement in the respective PROMIS domain T-score (Note: A higher PROMIS domain T-score represents more of the concept being measured. For the Ability to Participate in Social Roles and Activities domain an increase in T-score
Baseline to Weeks 14, 30, and 52
To assess the efficacy of therapy in inducing a meaningful clinical improvement in pain interference through Week 52 through a reduction in PROMIS - Pain Interference - Short Form Scores.
Time Frame: Baseline to Weeks 14, 30, and 52
Meaningful clinical improvement in each individual PROMIS domain at Weeks 14, 30, and 52
Baseline to Weeks 14, 30, and 52
To assess the efficacy of therapy in inducing a meaningful clinical improvement in fatigue through Week 52 through a reduction in PROMIS - Fatigue - Short Form Scores.
Time Frame: Baseline to Weeks 14, 30, and 52
Meaningful clinical improvement in each individual PROMIS domain at Weeks 14, 30, and 52
Baseline to Weeks 14, 30, and 52
To assess the efficacy of therapy in inducing a meaningful clinical improvement in anxiety through Week 52 through a reduction in PROMIS - Emotional Distress - Anxiety - Short Form Scores.
Time Frame: Baseline to Weeks 14, 30, and 52
Meaningful clinical improvement in each individual PROMIS domain at Weeks 14, 30, and 52
Baseline to Weeks 14, 30, and 52
To assess the efficacy of therapy in inducing a meaningful clinical improvement in depression through Week 52 through a reduction in PROMIS Emotional Distress - Depression - Short Form.
Time Frame: Baseline to Weeks 14, 30, and 52
Meaningful clinical improvement in each individual PROMIS domain at Weeks 14, 30, and 52
Baseline to Weeks 14, 30, and 52
To assess the efficacy of therapy in inducing a meaningful clinical improvement in sleep disturbance through Week 52 through a reduction in PROMIS - Sleep Disturbance - Short Form.
Time Frame: Baseline to Weeks 14, 30, and 52
Meaningful clinical improvement in each individual PROMIS domain at Weeks 14, 30, and 52
Baseline to Weeks 14, 30, and 52
To assess the efficacy of therapy in inducing a meaningful clinical improvement in physical function through Week 52 through a reduction in PROMIS - Physical Function - Short Form.
Time Frame: Baseline to Weeks 14, 30, and 52
Meaningful clinical improvement in each individual PROMIS domain at Weeks 14, 30, and 52
Baseline to Weeks 14, 30, and 52
To assess the efficacy of therapy in inducing a meaningful clinical improvement in ability to participate in social roles and activities through Week 52 through a reduction in PROMIS - Ability to Participate in Social Roles and Activities - Short Form.
Time Frame: Baseline to Weeks 14, 30, and 52
Meaningful clinical improvement in each individual PROMIS domain at Weeks 14, 30, and 52
Baseline to Weeks 14, 30, and 52
To assess early change in patient-reported symptoms within the PRO-2 through Week 14.
Time Frame: Baseline to Week 14
Change in PRO-2 (liquid/very soft stool frequency + abdominal pain) from baseline to Week 14.
Baseline to Week 14
To assess early change in patient-reported symptoms within the PROMIS - Pain Interference - Short Form through Week 14
Time Frame: Baseline to Week 14
Change in PROMIS Pain Interference-SF from baseline to Week 14.
Baseline to Week 14
To assess early change in patient-reported symptoms within the PROMIS - Fatigue - Short Form through Week 14
Time Frame: Baseline to Week 14
Change in PROMIS Fatigue-SF scores from baseline to Week 14.
Baseline to Week 14
To assess early change in patient-reported symptoms within the PROMIS - Anxiety - Short Form through Week 14
Time Frame: Baseline to Weeks 2, 6 and 14
Change in PROMIS Anxiety-SF-scores from baseline to Weeks 2, 6, and 14.
Baseline to Weeks 2, 6 and 14
To assess early change in patient-reported symptoms within the PROMIS - Depression - Short Form through Week 14
Time Frame: Baseline to Weeks 2, 6 and 14
Change in PROMIS Depression- SF-scores from baseline to Weeks 2, 6, and 14.
Baseline to Weeks 2, 6 and 14
To assess early change in patient-reported symptoms within the PROMIS - Sleep Disturbance - Short Form through Week 14
Time Frame: Baseline to Weeks 2, 6 and 14
Change in PROMIS Sleep Disturbance- SF-scores from baseline to Weeks 2, 6, and 14.
Baseline to Weeks 2, 6 and 14
To assess early change in patient-reported symptoms within the PROMIS - Physical Function - Short Form through Week 14
Time Frame: Baseline to Weeks 2, 6 and 14
Change in PROMIS Physical Function- SF-scores from baseline to Weeks 2, 6, and 14.
Baseline to Weeks 2, 6 and 14
To assess early change in patient-reported symptoms within the PROMIS - Ability to Participate in Social Roles and Activities - Short Form through Week 14
Time Frame: Baseline to Weeks 2, 6 and 14
Change in PROMIS Ability to Participate in Social Roles and Activities- SF-scores from baseline to Weeks 2, 6, and 14.
Baseline to Weeks 2, 6 and 14
To evaluate the association between the PRO-2 and each PROMIS domain
Time Frame: Baseline to Weeks 14, 30, and 52

Correlation between PRO-2 scores and each individual PROMIS domain T-score

• Correlation between change in PRO-2 scores and change in each individual PROMIS domain T-score
Baseline to Weeks 14, 30, and 52
To assess the efficacy of therapy in resolving fecal urgency defined by a change in UNRS scores from baseline through week 52.
Time Frame: Baseline to Weeks 2, 6, 14, 22, 30, 38, 46, and 52
SIBDQ remission (defined as an SIBDQ score ≥ 60) at Weeks 2, 6, 14, 22, 30, 38, 46, and 52
Baseline to Weeks 2, 6, 14, 22, 30, 38, 46, and 52
To assess the efficacy of therapy in resolving patient-reported symptoms and improving health related QOL as shown by SIBDQ improvement, defined as ≥ 9-point increase in the SIBDQ from baseline through week 52.
Time Frame: Baseline to Weeks 2, 6, 14, 22, 30, 38, 46, and 52
PRO-2 clinical response (defined as a decrease in the weighted PRO-2 of ≥ 50% from baseline) at Weeks 2, 6, 14, 22, 30, 38, 46, and 52
Baseline to Weeks 2, 6, 14, 22, 30, 38, 46, and 52
To assess the efficacy of therapy in resolving patient-reported symptoms and improving health related QOL as shown by obtaining SIBDQ remission, defined as an SIBDQ score ≥ 60 through week 52.
Time Frame: Baseline to Weeks 2, 6, 14, 22, 30, 38, 46, and 52
PRO-2 clinical remission (defined as a stool frequency score ≤ 3 and abdominal pain score ≤ 1 using unweighted subscores) at Weeks 2, 6, 14, 22, 30, 38, 46, and 52
Baseline to Weeks 2, 6, 14, 22, 30, 38, 46, and 52
To assess the durability of symptom improvement
Time Frame: Baseline to Week 14
PRO-2 clinical remission at Week 52 among participants who had PRO-2 clinical remission at Week 14
Baseline to Week 14
To assess the efficacy of therapy in resolving patient-reported symptoms by obtaining PRO-2 clinical remission, defined as a stool frequency score ≤ 3 and abdominal pain score ≤ 1 using unweighted subscores through week 52.
Time Frame: Baseline to Weeks 2, 6, 14, 22, 30, 38, 46, and 52
PRO-2 improvement (defined as a stool frequency score defined as a stool frequency score ≤ 3 and abdominal pain score ≤ 1 using unweighted subscores and no worsening of stool frequency and/or abdominal pain scores from baseline )
Baseline to Weeks 2, 6, 14, 22, 30, 38, 46, and 52
To assess the efficacy of therapy in resolving patient-reported symptoms by obtaining PRO-2 clinical response, defined as a decrease in the weighted PRO-2 of ≥ 50% from baseline through week 52.
Time Frame: Baseline to Weeks 2, 6, 14, 22, 30, 38, 46, and 52
PRO-2 enhanced clinical response defined as a decrease in the weighted PRO-2 of ≥ 50% from baseline through week 52
Baseline to Weeks 2, 6, 14, 22, 30, 38, 46, and 52
To assess the efficacy of therapy in resolving patient-reported symptoms by obtaining PRO-2 clinical response through week 52.
Time Frame: Baseline to Weeks 2, 6, 14, 22, 30, 38, 46, and 52
PRO-2 clinical response defined as ≥ 30% decrease from baseline in unweighted stool frequency score or a ≥ 30% decrease from baseline in unweighted abdominal pain scores, with neither increasing from baseline
Baseline to Weeks 2, 6, 14, 22, 30, 38, 46, and 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alimentiv Inc.

Collaborators

Takeda

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 24, 2024

First Submitted That Met QC Criteria

January 31, 2024

First Posted (Actual)

February 8, 2024

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 11, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAK01796

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Crohn's Disease

Clinical Trials on Vedolizumab (VDZ)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe