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Comparing risankizumab and vedolizumab for adults with moderate to severe ulcerative colitis

Phase 3b, Multicenter, Randomized, Open-Label Study of Risankizumab Compared to Vedolizumab for the Treatment of Adult Subjects With Moderate to Severe Ulcerative Colitis Who Are Naïve to Targeted Therapies

Phase 3 Interventional AbbVie · NCT06880744

This trial will test whether risankizumab or vedolizumab works better for adults with moderate to severe ulcerative colitis who have not previously used targeted therapies.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment530 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorAbbVie Industry-sponsored
Drugs / interventionsinfliximab, adalimumab, natalizumab, golimumab, ustekinumab, etrolizumab, vedolizumab, guselkumab, mirikizumab, risankizumab, tofacitinib, filgotinib, upadacitinib, radiation, prednisone
Locations270 sites (Birmingham, Alabama and 269 other locations)
Trial IDNCT06880744 on ClinicalTrials.gov

What this trial studies

This phase 3, open‑label randomized trial will enroll about 530 adults with moderate to severe ulcerative colitis who are naïve to targeted therapies and have active disease confirmed by modified Mayo Score and endoscopy. Participants are randomized 1:1 to receive risankizumab (intravenous induction then subcutaneous maintenance) or vedolizumab (intravenous dosing throughout) and will be followed for changes in disease activity and safety. The trial is sponsored by AbbVie and conducted at roughly 285 sites worldwide, including multiple U.S. clinical research centers. Eligible participants must have had inadequate response or intolerance to conventional UC treatments but no prior targeted biologic or small‑molecule therapy.

Who should consider this trial

Good fit: Adults with confirmed moderate to severe UC for at least 3 months, a modified Mayo Score of 5–9 with endoscopic subscore 2–3, who are naïve to targeted therapies and have had inadequate response or intolerance to conventional treatments are ideal candidates.

Not a fit: Patients who have previously received any targeted therapies for UC, those with Crohn's disease or IBD‑unclassified, or those with radiation or ischemic colitis are unlikely to be suitable or receive benefit from this protocol.

Why it matters

Potential benefit: If successful, the trial could show which approved drug gives better disease control or a more convenient regimen for TaT‑naive patients with moderate to severe ulcerative colitis.

How similar studies have performed: Both risankizumab and vedolizumab are approved for moderate to severe UC and have shown benefit in prior trials, but direct head‑to‑head comparisons in targeted‑therapy–naïve populations are limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Participant has confirmed diagnosis of Ulcerative Colitis (UC) for at least 3 months prior to Baseline.
* Participant has active UC with an modified Mayo Score (mMS) of 5 to 9 points and endoscopic subscore of 2 to 3 (confirmed by central reader).
* Participant has demonstrated intolerance or inadequate response to one or more of the following categories of drugs: aminosalicylates, oral locally acting steroids, systemic steroids (prednisone or equivalent), and immunomodulators.

Exclusion Criteria:

* Participant has received any targeted therapies (TaTs) for UC, including but not limited to infliximab, etanercept, adalimumab, natalizumab, golimumab, ozanimod, ustekinumab, etrolizumab, vedolizumab, tofacitinib, filgotinib, etrasimod, guselkumab, mirikizumab, upadacitinib, and risankizumab.
* Participant with a current diagnosis of Crohn's disease (CD) or Irritable Bowel Disease (IBD)-unclassified or a history of radiation colitis or ischemic colitis.
* Currently known complications of UC such as: fulminant colitis and/or toxic megacolon, acute severe UC, previous colectomy (total or subtotal), or any other manifestation that might require surgery while in the study
* Active systemic infection/clinically important infection during the last 2 weeks prior to Baseline Visit as assessed by the investigator.

Where this trial is running

Birmingham, Alabama and 269 other locations

+220 more sites — see ClinicalTrials.gov for the full list.

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 Ulcerative Colitis
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.