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New treatment option for Ulcerative Colitis
Official title A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC)
ClinicalTrials.gov ID: NCT06095128
What this study is testing
What is Vedolizumab?
Vedolizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ulcerative colitis.
Also referred to as Entyvio, MLN0002.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The main aim of this study is to learn about the effect of treatment with vedolizumab IV (vedolizumab) together with tofacitinib in adults with moderate and severe ulcerative colitis (UC). Another aim is to learn about treatment with Vedolizumab alone after the double treatment.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Has a confirmed diagnosis of UC established at least 3 months prior to screening, by clinical and endoscopic evidence and corroborated by a...
- Has moderately to severely active UC as determined by a complete Mayo score [including physician's global assessment (PGA)] of 6 to 12 with a rectal...
- Has evidence of UC extending proximally to the rectum [≥15 centimeter (cm) of involved colon].
- Participants with extensive colitis or pancolitis of \>8 years duration or left sided colitis \>12 years duration must have documented evidence that...
- Participants with a family history of colorectal cancer, personal history of increased colorectal cancer risk, age \>50 years, or other known risk...
You likely can't join if
- Gastrointestinal Exclusion criteria:
- Has any of the following UC-related complications:
- Acute severe UC.
- The participant has had extensive colonic resection, subtotal or total colectomy.
- The participant has clinical evidence of abdominal abscess or toxic megacolon.
- The participant has an ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
See the full eligibility criteria
Who can join
- Has a confirmed diagnosis of UC established at least 3 months prior to screening, by clinical and endoscopic evidence and corroborated by a histopathology report.
- Has moderately to severely active UC as determined by a complete Mayo score [including physician's global assessment (PGA)] of 6 to 12 with a rectal bleeding subscore ≥1 and a centrally assessed endoscopic subscore ≥2...
- Has evidence of UC extending proximally to the rectum [≥15 centimeter (cm) of involved colon].
- Participants with extensive colitis or pancolitis of \>8 years duration or left sided colitis \>12 years duration must have documented evidence that a surveillance colonoscopy was performed within 12 months of the...
- Participants with a family history of colorectal cancer, personal history of increased colorectal cancer risk, age \>50 years, or other known risk factors must be up to date on colorectal cancer surveillance.
- Has demonstrated an inadequate response to, loss of response to, or intolerance to at least 1, but no more than 2 TNFα antagonists. Participants without prior failure or intolerance to biologics are not eligible...
- If using corticosteroids must be on a stable dose of oral corticosteroids up to a maximum of 40 mg daily of prednisone or 9 mg daily of budesonide, or equivalent for at least 2 weeks prior to screening endoscopy and...
What rules you out
- Gastrointestinal Exclusion criteria:
- Has any of the following UC-related complications:
- Acute severe UC.
- The participant has had extensive colonic resection, subtotal or total colectomy.
- The participant has clinical evidence of abdominal abscess or toxic megacolon.
- The participant has an ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
- Short bowel syndrome.
- Has Crohn's colitis, indeterminate colitis, ischemic colitis, nonsteroidal anti-inflammatory drug (NSAID) induced colitis, idiopathic colitis (i.e, colitis not consistent with UC), radiation colitis, microscopic...
- Has uncontrolled primary sclerosing cholangitis. Infectious Disease Exclusion Criteria:
- Has any evidence of an active systemic infection during screening. Participants with nonsystemic infections (eg, active fungal infection of nail beds) may be eligible, if in the opinion of the investigator, inclusion of...
- Has active or latent tuberculosis (TB), regardless of treatment history, as evidenced by any of the following:
- History of TB.
- A diagnostic TB test performed during screening that is positive, as defined by: i. A positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests or ii. A tuberculin skin test reaction ≥10 mm (≥5 mm in...
- A positive test for hepatitis B virus (HBV).
- A positive test for hepatitis C virus (HCV).
- Evidence of, or treatment for, Clostridium difficile infection or other intestinal pathogen within 28 days prior to first dose of study treatment. Participants who test positive for C. difficile or other intestinal...
- Evidence of active Cytomegalovirus (CMV) infection at screening. Medication exclusion criteria:
- Has received immunomodulators (eg, 6-mercaptopurine, azathioprine, and methotrexate) within 4 weeks prior to first dose or immunosuppressants (eg, cyclosporine, tacrolimus) within 8 weeks prior to first dose.
- Any medicinal product, herbal medication, or natural health product which might interfere with cytochrome P450 genotype 3A4 (CYP3A4) within 2 weeks prior to enrollment, except for any CYP3A4 modulator used to treat a C...
- Has received any of the following medical therapies for UC:
- IV antibiotics within 8 weeks prior to enrollment.
- Any rectal therapy for treatment of UC within 2 weeks prior to screening endoscopy.
- Chronic NSAID use defined as daily use for \>2 consecutive weeks (Note: occasional use [\<2 consecutive weeks] of NSAIDs and acetaminophen [\<100 mg daily] for headache, arthritis, myalgias, or menstrual cramps and...
- Has received a live virus or live bacterial vaccine within 4 weeks prior to enrollment or planned vaccination during the study and for 12 weeks after last dose. General Exclusion Criteria:
- Has any of the following cardiovascular or thrombotic conditions:
- Recent (within past 6 months) cerebrovascular accident, myocardial infarction, or coronary stenting.
- Recent (within past 6 months) moderate to severe congestive heart failure (New York Heart Association class III or IV).
- Prior history of thrombotic events, including deep vein thrombosis and pulmonary embolism.
- Known inherited conditions that predispose to hypercoagulability.
- History of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly.
- A surgical procedure requiring general anesthesia within 3 months prior to screening or is planning to undergo major surgery during the study period.
- Any investigational procedure ≤4 weeks prior to screening that, in the investigator's opinion, may interfere with interpretation of study results.
The study team makes the final eligibility decision.
Where it's taking place
- Dothan, Alabama, United States
- Sun City, Arizona, United States
- Los Angeles, California, United States
- Newport Beach, California, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Roswell, Georgia, United States
- Chicago, Illinois, United States
- Glenview, Illinois, United States
- Gurnee, Illinois, United States
- Kansas City, Kansas, United States
- Louisville, Kentucky, United States
- Metairie, Louisiana, United States
- New Orleans, Louisiana, United States
- Chevy Chase, Maryland, United States
- Ypsilanti, Michigan, United States
- Plymouth, Minnesota, United States
- Kansas City, Missouri, United States
- Liberty, Missouri, United States
- St Louis, Missouri, United States
+ 28 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dothan, Alabama, United States; Sun City, Arizona, United States; Los Angeles, California, United States; Newport Beach, California, United States; Orlando, Florida, United States; Tampa, Florida, United States and 42 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.