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

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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]). a. 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.

🚫 You may not be able to join if…

• 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.

Where this trial is running

• GI Alliance - Sun City, Sun City, Arizona, United States
• Digestive and Liver Center of Florida, Kissimmee, Florida, United States
• Northwestern University, Evanston, Illinois, United States
• University of Iowa, Iowa City, Iowa, United States
• University Medical Center New Orleans, New Orleans, Louisiana, United States
• Brigham and Women's Hospital, Chestnut Hill, Massachusetts, United States
• University of North Carolina, Chapel Hill, North Carolina, United States
• Cleveland Clinic Foundation, Cleveland, Ohio, United States
• OR Clinic - East - GI, Portland, Oregon, United States
• GI Alliance Research Fort Worth, Fort Worth, Texas, United States
• GI Alliance Research Mansfield, Mansfield, Texas, United States
• GI Alliance - Bellevue - Washington Gastroenterology, Bellevue, Washington, United States

+ 13 more sites.

Who to contact

Susan Archer · 226-919-6959 · susan.archer@alimentiv.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06249555.