Search / Trial NCT06227910

A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease

Launched by TAKEDA · Jan 19, 2024

Trial Information

Current as of December 22, 2024

Not yet recruiting

Keywords

Drug Therapy

ClinConnect Summary

The drug being tested in this study is vedolizumab. Vedolizumab is being tested to treat people with moderately to severely active CD. The study will look at the efficacy and safety of vedolizumab with and without upadacitinib. The study will enroll approximately 396 patients. Participants will be assigned in a 1:1 ratio to one of the two treatment groups in the 12-weeks Induction Phase:

* Induction Phase: Vedolizumab + Upadacitinib
* Induction Phase: Vedolizumab + Placebo

Participants who achieve a Crohn's disease activity index (CDAI) reduction of greater than or equal to (\>=)70 points...

Gender

ALL

Eligibility 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.

Trial Officials

Study Director

Study Director

Takeda

About Takeda

Takeda Pharmaceutical Company Limited is a global, research-driven biopharmaceutical organization committed to advancing patient care through innovative therapies. Founded in 1781 and headquartered in Osaka, Japan, Takeda focuses on key therapeutic areas including oncology, gastroenterology, neuroscience, and rare diseases. With a strong emphasis on research and development, Takeda leverages cutting-edge science and technology to deliver transformative medicines that address unmet medical needs. The company is dedicated to sustainability and ethical practices, ensuring that its clinical trials uphold the highest standards of safety and efficacy while fostering collaboration with healthcare professionals and communities worldwide.

Locations

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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