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VERDICT - Optimal Treatment Target in Active Ulcerative Colitis (UC)
EU CTIS ID: 2024-514183-21-00
What this study is testing
The primary objective of this trial is to determine whether, in subjects with moderately to severely active UC, treating to achieve a target of corticosteroid-free symptomatic + endoscopic + histological remission is superior to a treatment target of corticosteroid-free symptomatic remission, with regards to a primary endpoint of time to UC-related complication within up to 80 weeks of follow-up after achieving target.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years.
- Up to date with colorectal carcinoma surveillance according to local standards and guidelines. If a subject is not up to date at screening, a standard of care surveillance assessment may be performed during the screening period.
- Diagnosis of UC confirmed by clinical, endoscopic, and histological evidence prior to screening as per standard criteria.
- Moderately to severely active UC with a Mayo rectal bleeding subscore ≥ 1 and a Mayo endoscopic subscore (MES) ≥ 2, with a minimum disease extent of 15 cm and objective evidence of inflammation that can be visualized using a central endoscopic imaging system.
- Ability of subject to participate fully in all aspects of this clinical trial.
- Written informed consent must be obtained and documented.
You likely can't join if
- Subjects who have historically failed (i.e., had an inadequate response with, lost response to, or were intolerant to) 2 or more compounds or classes of advanced therapeutic options (biologics or small molecules; e.g., anti TNFs, ustekinumab, or tofacitinib) for the treatment of their UC.
- Received any investigational drug within 30 days prior to randomization/target assignment.
- Serious underlying disease other than UC that in the opinion of the investigator may interfere with the subject’s ability to participate fully in the study or would compromise subject safety (such as history of malignancies, major neurological disorders, any unstable or uncontrolled medical disorder).
- History of alcohol or drug abuse that in the opinion of the investigator may interfere with the subject’s ability to comply with the study procedures.
- The subject has active cerebral/meningeal disease, signs/symptoms, or any history of progressive multifocal leukoencephalopathy (PML) prior to randomization.
- Hypersensitivity to any excipient of vedolizumab.
See the full eligibility criteria
Who can join
- Age ≥ 18 years.
- Up to date with colorectal carcinoma surveillance according to local standards and guidelines. If a subject is not up to date at screening, a standard of care surveillance assessment may be performed during the screening period.
- Diagnosis of UC confirmed by clinical, endoscopic, and histological evidence prior to screening as per standard criteria.
- Moderately to severely active UC with a Mayo rectal bleeding subscore ≥ 1 and a Mayo endoscopic subscore (MES) ≥ 2, with a minimum disease extent of 15 cm and objective evidence of inflammation that can be visualized using a central endoscopic imaging system.
- Ability of subject to participate fully in all aspects of this clinical trial.
- Written informed consent must be obtained and documented.
- Agree not to participate in an investigation trial for the duration of this trial (observational or other noninterventional trials may be permitted at the discretion of the investigator).
- Negative standard of care tuberculosis (TB) test and hepatitis B and C test prior to randomization unless negative results available from within 12 months prior.
- A male subject who is nonsterilized* and sexually active with a female partner of childbearing potential* agrees to use adequate contraception* from signing of informed consent throughout the duration of the study and for 18 weeks after last dose.
- A female subject of childbearing potential* who is sexually active with a nonsterilized* male partner agrees to use routinely adequate contraception* from signing of informed consent throughout the duration of the study and for 18 weeks after last dose.
What rules you out
- Subjects who have historically failed (i.e., had an inadequate response with, lost response to, or were intolerant to) 2 or more compounds or classes of advanced therapeutic options (biologics or small molecules; e.g., anti TNFs, ustekinumab, or tofacitinib) for the treatment of their UC.
- Received any investigational drug within 30 days prior to randomization/target assignment.
- Serious underlying disease other than UC that in the opinion of the investigator may interfere with the subject’s ability to participate fully in the study or would compromise subject safety (such as history of malignancies, major neurological disorders, any unstable or uncontrolled medical disorder).
- History of alcohol or drug abuse that in the opinion of the investigator may interfere with the subject’s ability to comply with the study procedures.
- The subject has active cerebral/meningeal disease, signs/symptoms, or any history of progressive multifocal leukoencephalopathy (PML) prior to randomization.
- Hypersensitivity to any excipient of vedolizumab.
- Active severe infection such as sepsis, cytomegalovirus, listeriosis, or opportunistic infection.
- If female, the subject is pregnant or lactating or intending to become pregnant before, during, or within 18 weeks after the last dose; or intending to donate ova during such time period.
- If male, the subject intends to donate sperm during the course of this study or for 18 weeks after the last dose.
- Vaccination with a live or live-attenuated vaccine within 4 weeks prior to randomization, or planned vaccination during conduct of the study, except vaccination for coronavirus disease of 2019 (COVID 19).
- Current or previous treatment with vedolizumab, etrolizumab, or natalizumab.
- Topical therapy (corticosteroid or 5-aminosalicylate) use within 2 weeks prior to screening endoscopy.
- Change to oral corticosteroid therapy dosing within 2 weeks prior to randomization or a corticosteroid dose of >30 mg of prednisone or equivalent at randomization.
- Known diagnosis of Crohn’s disease, indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis.
- Short gut syndrome.
- Positive stool culture or active Clostridioides difficile infection (as demonstrated by positive toxin and/or antigen).
- Known hepatitis B or C infection; if a negative test result is available in the 12 months prior to randomization, retesting is not required.
- Known active or latent TB; if a negative test result is available in the 12 months prior to randomization, confirmatory testing (per standard of care) is not required before randomization.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Belarus
- Canada
- United States
- Ukraine
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Belarus; Canada; United States; Ukraine. 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 EU CTIS; the study team decides eligibility.