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Optimal Treatment Strategies for Ulcerative Colitis (VERDICT Trial)
Phase 4
Waitlist Available
Led By Vipul Jairath, MD
Research Sponsored by Alimentiv Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, weeks 8, 16, 32, 48, 64, 80, and 96
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial will help determine the optimal treatment target for UC.
Who is the study for?
Adults with active Ulcerative Colitis (UC) confirmed by clinical, endoscopic, and histological evidence can join this trial. They must be experiencing moderate to severe symptoms and not responding to current treatments. Participants should agree not to join other investigational trials during this study, be up-to-date on colorectal cancer screenings, and willing to undergo TB and hepatitis tests. Contraception is required for sexually active participants.
What is being tested?
The trial aims to find the best treatment target for UC by comparing three groups: one targeting symptom remission without steroids; another adding endoscopic remission; the third includes histological remission as well. Patients are randomly assigned in a 2:3:5 ratio respectively.
What are the potential side effects?
Potential side effects aren't specified but may include reactions related to UC treatments such as biologics or small molecules like abdominal pain, infection risks, infusion-related reactions, headache, nausea or fatigue.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, weeks 8, 16, 32, 48, 64, 80, and 96
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weeks 8, 16, 32, 48, 64, 80, and 96
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Difference in Time to UC-related Complication Between Treatment Target Groups 1 and 3
Secondary study objectives
Assess the effect of treatment(s) on UC-related complications
C-reactive protein
Describe the change in Geboes scores from baseline to baseline to Week 16, 32, 48 and 96/end of study (EOS)
+15 moreAwards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Symptomatic, endoscopic and histological remissionExperimental Treatment3 Interventions
Treatment target defined as achievement of corticosteroid-free symptomatic remission plus endoscopic remission plus histological remission.
Group II: Symptomatic remissionExperimental Treatment3 Interventions
Treatment target defined as achievement of corticosteroid-free symptomatic remission.
Group III: Symptomatic and endoscopic remissionExperimental Treatment3 Interventions
Treatment target defined as achievement of corticosteroid-free symptomatic remission plus endoscopic remission.
Find a Location
Who is running the clinical trial?
Alimentiv Inc.Lead Sponsor
14 Previous Clinical Trials
2,582 Total Patients Enrolled
5 Trials studying Ulcerative Colitis
134 Patients Enrolled for Ulcerative Colitis
Takeda Development Center Americas, Inc.Industry Sponsor
56 Previous Clinical Trials
10,101 Total Patients Enrolled
2 Trials studying Ulcerative Colitis
148 Patients Enrolled for Ulcerative Colitis
Vipul Jairath, MDPrincipal InvestigatorAlimentiv Inc.
2 Previous Clinical Trials
638 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have short gut syndrome.I have been treated with vedolizumab, etrolizumab, or natalizumab.I have never had brain-related health issues like PML.I do not have active or latent TB, or I have a negative TB test in the last year.My ulcerative colitis is active, with bleeding and inflammation seen in a colonoscopy.I have no medical reasons preventing me from taking vedolizumab.I have HIV or tested positive for it in Italy.I am current with my colorectal cancer screenings as per guidelines.I haven't changed my oral steroid dose in the last 2 weeks and take no more than 30 mg of prednisone or its equivalent.I am a man who can father children and will use birth control during and for 18 weeks after the study.I am 18 years old or older.I haven't had any live vaccines in the last 4 weeks, except for COVID-19.My ulcerative colitis diagnosis was confirmed by tests and doctor's evaluation.I am a male and do not plan to donate sperm during the study or for 18 weeks after.My current treatment for ulcerative colitis is not working.I have used topical treatments like corticosteroids or 5-ASA in the last 2 weeks.I agree to use birth control during and for 18 weeks after the study.I do not have a severe infection like sepsis or CMV.I have been diagnosed with a specific type of colitis.I am not pregnant, breastfeeding, planning to become pregnant, or donate eggs within 18 weeks after the last dose.I have tried at least 2 different treatments for my UC without success.I can fully participate in all parts of this clinical trial.
Research Study Groups:
This trial has the following groups:- Group 1: Symptomatic and endoscopic remission
- Group 2: Symptomatic, endoscopic and histological remission
- Group 3: Symptomatic remission
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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