RightFit
RecruitingPhase 3

A Study of Vedolizumab With and Without Upadacitinib in Adults With 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "All participants will receive DTT (either vedolizumab and upadacitinib or vedolizumab and placebo) for 12 weeks."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for adults with moderately to severely active Crohn’s disease. It tests whether vedolizumab plus upadacitinib reduces bowel swelling and sores more than vedolizumab alone after 12 weeks. It also compares how safe the treatments are and how well they work.

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 will then receive vedolizumab only (monotherapy) for an additional 40 weeks. During the study, participants will visit their study clinic 15 times.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You have had a Crohn’s disease diagnosis for at least 3 months before screening, confirmed by symptoms, a bowel scope exam, and a tissue sample report.
  • Your Crohn’s disease is moderately to severely active, with a disease activity score (CDAI) of 220–450.
  • A bowel scope exam shows swelling in the bowel lining, with an SES-CD score of at least 6, or at least 4 if only the last part of your small bowel is affected.
  • Steroids, medicines that change the immune system, or biologic medicines did not work well, stopped working, or caused side effects you could not tolerate.

Who can't join

  • You have ulcerative colitis or colitis of an unclear type, which are other forms of bowel inflammation.
  • You needed infection medicine through a vein within 30 days before treatment starts, or by mouth or muscle shot within 14 days.
  • You have an active infection during screening, a serious infection within 30 days before screening, or an ongoing long-term infection.
  • You have had shingles more than once, shingles that spread widely, or herpes simplex that spread widely.
  • You have certain Crohn’s complications: a pocket of pus in the belly or near the anus; narrowed bowel causing symptoms; two whole bowel sections missing from the study’s listed sections; very severe colon inflammation; a dangerously swollen colon; or another problem that may need surgery during the study.
  • You have an ostomy (a bowel opening in the belly) or an ileoanal pouch (an internal pouch made from the small bowel).
  • You have very poor kidney function, with a kidney filtering score (eGFR) below 30.
  • You have severe liver damage rated Child-Pugh C.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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.

Study sites (19)

CA

CO

FL

IN

KY

NY

SC

SD

TX

WA

WI