Crohn's DiseaseVOICENCT06249555
VOICE-Early Response to Vedolizumab and IL-23 Antagonists in Participants With Crohn's Disease: A Prospective Observational Study
An observational study of Crohn's Disease, run by Alimentiv Inc. at 24 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Vedolizumab (VDZ), Ustekinumab (UST) and Risankizumab (RISA)
- How many people
- 300 participants
- Where
- 24 sitesin 2 countries
- Study dates
- 20 Mar 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
- 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.
- Participant has a baseline PROMIS Pain Interference-SF score ≥ 15 (corresponding T-score ≥ 55) (PROMIS Pain Interference-SF 8a [V1.1]).
- Score is calculated by adding score (1 to 5) for each of the 8 subcomponents.
- 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).
- 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.
Who cannot join
- Participant has CD-related surgery planned or anticipated during the study.
- 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.
- 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.
- 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.
- Participant has chronic non-inflammatory bowel disease pain.
Trial locations and contacts
24 sites in 2 countries.
24 sites in 2 countries
Canada13 sites
GNRR Digestive Clinics and Research Center
Brampton, Ontario, L6S0E2
University of Alberta
Edmonton, Alberta, T6G2X8
McMaster University Medical Center
Hamilton, Ontatrio, L8N 3Z5
London Health Sciences Centre
London, Ontario, N6A5A5
Alimentiv
London, Ontario, N6Z5B6
West GTA Research Inc.
Mississauga, Ontario, L5M7N4
Montreal General Hospital
Montreal, Quebec, H3G1A4
Rajbir Rai Medicine Professional Corporation
Oakville, Ontario, L6L4P7
ABP Research Services Corp.
Oakville, Ontario, L6L5L7
The Ottawa Hospital
Ottawa, Ontario, K1H8L6
Scarborough Center for Inflammatory Bowel Disease
Scarborough Village, Ontario, M1B3V4
Toronto Immune & Digestive Health Institute Inc.
Toronto, Ontario, M6A3B4
University of British Columbia
Vancouver, British Columbia, V6Z2K5
United States11 sites
GI Alliance - Bellevue - Washington Gastroenterology
Bellevue, Washington, 98004
University of North Carolina
Chapel Hill, North Carolina, 27599
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, 02467
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Northwestern University
Evanston, Illinois, 60611
GI Alliance Research Fort Worth
Fort Worth, Texas, 76104
University of Iowa
Iowa City, Iowa, 52242
GI Alliance Research Mansfield
Mansfield, Texas, 76063
University Medical Center New Orleans
New Orleans, Louisiana, 70112
OR Clinic - East - GI
Portland, Oregon, 97220
GI Alliance - Sun City
Sun City, Arizona, 85351
About this study
Official title: 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.
Read the 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.
- Conditions
- Crohn's Disease
- Being tested
- Vedolizumab (VDZ), Ustekinumab (UST), Risankizumab (RISA), Guselkumab (GUS), Mirikizumab (MIR)
- Keywords
- Vedolizumab, Ustekinumab, Patient reported outcome, IL-23 antagonists, Risankizumab
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vedolizumab (VDZ)Drug
Also called Entyvio
Participants will receive VDZ as part of routine care.
Ustekinumab (UST)Drug
Also called Stelara
Participants will receive UST as part of routine care.
Risankizumab (RISA)Drug
Also called Skyrizi
Participants will receive RISA as part of routine care.
Guselkumab (GUS)Drug
Also called Tremfya
Participants will receive GUS as part of routine care.
Mirikizumab (MIR)Drug
Also called Omvoh
Participants will receive MIR as part of routine care.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Vedolizumab (VDZ) | |
| 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. Receives: Drug: Ustekinumab (UST); Drug: Risankizumab (RISA); Drug: Guselkumab (GUS); Drug: Mirikizumab (MIR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess time of onset of biologic therapy in pain interference
Time to meaningful clinical improvement in pain interference, defined as a ≥ 2-point decrease in the PROMIS Pain Interference-SF T-score
Measured: Baseline to Week 14
Secondary outcomes (24)
To assess time of onset of biologic therapy in multiple QOL and functioning domains
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
Measured: 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.
Meaningful clinical improvement in each individual PROMIS domain at Weeks 14, 30, and 52
Measured: 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.
Meaningful clinical improvement in each individual PROMIS domain at Weeks 14, 30, and 52
Measured: 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.
Meaningful clinical improvement in each individual PROMIS domain at Weeks 14, 30, and 52
Measured: 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.
Meaningful clinical improvement in each individual PROMIS domain at Weeks 14, 30, and 52
Measured: 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.
Meaningful clinical improvement in each individual PROMIS domain at Weeks 14, 30, and 52
Measured: 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.
Meaningful clinical improvement in each individual PROMIS domain at Weeks 14, 30, and 52
Measured: 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.
Meaningful clinical improvement in each individual PROMIS domain at Weeks 14, 30, and 52
Measured: Baseline to Weeks 14, 30, and 52
To assess early change in patient-reported symptoms within the PRO-2 through Week 14.
Change in PRO-2 (liquid/very soft stool frequency + abdominal pain) from baseline to Week 14.
Measured: Baseline to Week 14
To assess early change in patient-reported symptoms within the PROMIS - Pain Interference - Short Form through Week 14
Change in PROMIS Pain Interference-SF from baseline to Week 14.
Measured: Baseline to Week 14
To assess early change in patient-reported symptoms within the PROMIS - Fatigue - Short Form through Week 14
Change in PROMIS Fatigue-SF scores from baseline to Week 14.
Measured: Baseline to Week 14
To assess early change in patient-reported symptoms within the PROMIS - Anxiety - Short Form through Week 14
Change in PROMIS Anxiety-SF-scores from baseline to Weeks 2, 6, and 14.
Measured: Baseline to Weeks 2, 6 and 14
To assess early change in patient-reported symptoms within the PROMIS - Depression - Short Form through Week 14
Change in PROMIS Depression- SF-scores from baseline to Weeks 2, 6, and 14.
Measured: 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
Change in PROMIS Sleep Disturbance- SF-scores from baseline to Weeks 2, 6, and 14.
Measured: 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
Change in PROMIS Physical Function- SF-scores from baseline to Weeks 2, 6, and 14.
Measured: 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
Change in PROMIS Ability to Participate in Social Roles and Activities- SF-scores from baseline to Weeks 2, 6, and 14.
Measured: Baseline to Weeks 2, 6 and 14
To evaluate the association between the PRO-2 and each PROMIS domain
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
Measured: Baseline to Weeks 14, 30, and 52
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.
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 )
Measured: 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.
PRO-2 enhanced clinical response defined as a decrease in the weighted PRO-2 of ≥ 50% from baseline through week 52
Measured: Baseline to Weeks 2, 6, 14, 22, 30, 38, 46, and 52
To assess the efficacy of therapy in resolving fecal urgency defined by a change in UNRS scores from baseline through week 52.
SIBDQ remission (defined as an SIBDQ score ≥ 60) at Weeks 2, 6, 14, 22, 30, 38, 46, and 52
Measured: 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.
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
Measured: 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.
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
Measured: Baseline to Weeks 2, 6, 14, 22, 30, 38, 46, and 52
To assess the durability of symptom improvement
PRO-2 clinical remission at Week 52 among participants who had PRO-2 clinical remission at Week 14
Measured: Baseline to Week 14
To assess the efficacy of therapy in resolving patient-reported symptoms by obtaining PRO-2 clinical response through week 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
Measured: Baseline to Weeks 2, 6, 14, 22, 30, 38, 46, and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start20 Mar 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alimentiv Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06249555
- Sponsor's protocol ID
- TAK01796
- Acronym
- VOICE
- Status last verified
- Aug 2026
- First submitted
- 24 Jan 2024
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06249555
- Acronym / sponsor ID
- VOICE / TAK01796
- Conditions
- Crohn's Disease
- Keywords
- Vedolizumab, Ustekinumab, Patient reported outcome, IL-23 antagonists, Risankizumab
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Alimentiv Inc.University, hospital or other
- Collaborators
- Takeda
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vedolizumab | – | Drug: Vedolizumab (VDZ)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. |
| IL-23 Antagonists | – | Drug: Ustekinumab (UST), Drug: Risankizumab (RISA), Drug: Guselkumab (GUS), Drug: Mirikizumab (MIR)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
- 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.
- Participant has a baseline PROMIS Pain Interference-SF score ≥ 15 (corresponding T-score ≥ 55) (PROMIS Pain Interference-SF 8a [V1.1]).
- 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).
- 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.
Key exclusion criteria (6 listed)
- Participant has CD-related surgery planned or anticipated during the study.
- 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.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vedolizumab (VDZ)Also: EntyvioParticipants will receive VDZ as part of routine care. | Drug | Vedolizumab |
| Ustekinumab (UST)Also: StelaraParticipants will receive UST as part of routine care. | Drug | IL-23 Antagonists |
| Risankizumab (RISA)Also: SkyriziParticipants will receive RISA as part of routine care. | Drug | IL-23 Antagonists |
| Guselkumab (GUS)Also: TremfyaParticipants will receive GUS as part of routine care. | Drug | IL-23 Antagonists |
| Mirikizumab (MIR)Also: OmvohParticipants will receive MIR as part of routine care. | Drug | IL-23 Antagonists |
Primary outcome
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
24 secondary outcomes
To assess time of onset of biologic therapy in multiple QOL and functioning domains
Time frame: 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
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
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
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
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
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
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
To assess early change in patient-reported symptoms within the PRO-2 through Week 14.
Time frame: 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
To assess early change in patient-reported symptoms within the PROMIS - Fatigue - Short Form through Week 14
Time frame: 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
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
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
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
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
To evaluate the association between the PRO-2 and each PROMIS domain
Time frame: Baseline to Weeks 14, 30, and 52
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
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
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
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
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
To assess the durability of symptom improvement
Time frame: Baseline to Week 14
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease, run by Alimentiv Inc. at 24 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess time of onset of biologic therapy in pain interference (time frame: Baseline to Week 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.