ClinicaliQ Trial Snapshot
- A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn’s Disease — Recruiting • Phase III • Oncology • NCT06227910.
- What is being tested: The efficacy of dual targeted therapy combining vedolizumab (α4β7 integrin inhibitor) and upadacitinib (JAK inhibitor) versus vedolizumab monotherapy in reducing bowel inflammation and ulceration in adults with Crohn's disease.
- Patient eligibility overview: Adult patients with Crohn's disease who are suitable candidates for targeted biologic and small molecule immunosuppressive therapies, though specific disease activity thresholds and prior treatment history would define precise inclusion criteria.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
The main aim of this study is to learn whether vedolizumab and upadacitinib given together (also called dual targeted therapy or DTT) reduces bowel inflammation and ulcers in the bowel compared to vedolizumab only (also called monotherapy) in adults with moderately or severely active Crohn's Disease (CD) after 12 weeks of treatment. Other aims are to learn how safe and effective DTT is compared to monotherapy for these participants. All participants will receive DTT (either vedolizumab and upadacitinib or vedolizumab and placebo) for 12 weeks. Participants responding to the treatment…
Eligibility Snapshot
- : 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 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.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.