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Combining vedolizumab and upadacitinib for treating Crohn's Disease

A Randomized, Double-Blind, Phase 3b Study to Evaluate the Short- and Long-Term Efficacy and Safety of Dual Targeted Therapy With Intravenous Vedolizumab and Oral Upadacitinib Compared With Intravenous Vedolizumab and Oral Placebo for Induction Followed by Intravenous Vedolizumab Monotherapy for Maintenance in the Treatment of Adults With Moderately to Severely Active Crohn's Disease

PHASE3 · Takeda · NCT06227910

This study is testing if combining two medications, vedolizumab and upadacitinib, can help adults with moderate to severe Crohn's Disease feel better compared to using vedolizumab alone.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment396 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorTakeda (industry)
Drugs / interventionsvedolizumab, upadacitinib
Locations138 sites (La Jolla, California and 137 other locations)
Trial IDNCT06227910 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness and safety of dual targeted therapy (DTT) using vedolizumab and upadacitinib compared to vedolizumab alone in adults with moderately to severely active Crohn's Disease. Participants will be randomly assigned to receive either the combination therapy or vedolizumab with a placebo for 12 weeks. Those who respond positively will continue with vedolizumab monotherapy for an additional 40 weeks. The study will involve multiple clinic visits and aims to assess bowel inflammation and ulcer reduction.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with moderately to severely active Crohn's Disease who have not responded adequately to previous treatments.

Not a fit: Patients with ulcerative colitis or those who have not had an adequate response to the therapies being tested may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a more effective treatment option for patients with Crohn's Disease, potentially leading to better management of their symptoms.

How similar studies have performed: Other studies have shown promise with similar combination therapies, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. The participant has a diagnosis of CD established at least 3 months before screening by clinical and endoscopic evidence and corroborated by a histopathology report.
2. The participant has a confirmed diagnosis of moderately to severely active CD as assessed by CDAI of 220-450.
3. The participant has evidence of mucosal inflammation based on the SES-CD: SES-CD score (excluding the presence of narrowing component) of \>=6 (or \>=4 for participants with isolated ileal disease), as confirmed by a central reader.
4. The participant has demonstrated an inadequate response to, loss of response to, or intolerance to corticosteroids, immunomodulators, or biologic therapy.

Exclusion Criteria:

1. The participant has a current diagnosis of ulcerative colitis or indeterminate colitis.
2. The participant has infection(s) requiring treatment with IV anti-infectives within 30 days prior to baseline or oral/intramuscular anti-infectives within 14 days prior to baseline.
3. The participant has evidence of an active infection during the screening period, or clinically significant infection within 30 days prior to screening, or ongoing chronic infection.
4. The participant has a history of recurrent or disseminated (including a single episode) herpes zoster, or disseminated (including a single episode) herpes simplex.
5. The participant has any of the following ongoing known complications of CD: abscess (abdominal or peri-anal); symptomatic bowel strictures; 2 entire missing segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum; fulminant colitis; toxic megacolon; or any other manifestation that might require surgery while enrolled in the study.
6. The participant has an ostomy or ileoanal pouch.
7. The participant has severe renal impairment, defined as an estimated glomerular filtration rate of \<30 milliliters per minute per 1.73 square meters (mL/min/1.73 m\^2).
8. The participant has severe (Child-Pugh C) hepatic impairment.

Where this trial is running

La Jolla, California and 137 other locations

+88 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 →

Conditions: Crohn's Disease, Drug Therapy

Last reviewed 2026-05-15 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.