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Exploring early responses to Vedolizumab and IL-23 antagonists in Crohn's disease patients

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

Observational Alimentiv Inc. · NCT06249555

This study is testing how quickly people with Crohn's disease feel better after starting treatment with Vedolizumab or IL-23 antagonists, using their feedback on symptoms like pain and fatigue.

Quick facts

Study typeObservational
Enrollment300 (estimated)
Ages18 Years and up
SexAll
SponsorAlimentiv Inc. Academic / other
Drugs / interventionsinfliximab, adalimumab, certolizumab, Vedolizumab, ustekinumab, risankizumab
Locations25 sites (Sun City, Arizona and 24 other locations)
Trial IDNCT06249555 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate the time course of response to Vedolizumab in adults with Crohn's disease, utilizing the Patient-Reported Outcomes Measurement Information System (PROMIS) to assess various health domains such as pain, fatigue, and physical function. Participants will be those starting treatment with Vedolizumab or IL-23 antagonists for the first time, and their responses will be monitored over time. The study will also compare the perceived onset of action of Vedolizumab with that of newer therapies like Risankizumab. By gathering patient-reported outcomes, the study seeks to provide insights into the effectiveness and patient experience of these treatments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with confirmed active Crohn's disease who are starting treatment with Vedolizumab or IL-23 antagonists for the first time.

Not a fit: Patients who are not starting treatment with Vedolizumab or IL-23 antagonists or those with inactive Crohn's disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of treatment responses in Crohn's disease, leading to improved patient management and outcomes.

How similar studies have performed: Previous studies have shown promising results with Vedolizumab and IL-23 antagonists in treating Crohn's disease, indicating that this approach is grounded in existing evidence.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Sun City, Arizona and 24 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Crohn's DiseaseVedolizumabUstekinumabPatient reported outcomeIL-23 antagonistsRisankizumab
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.