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Optimal Treatment Strategies for Ulcerative Colitis (VERDICT Trial)

Phase 4
Recruiting
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
Moderately to severely active UC with a Mayo rectal bleeding subscore ≥ 1 and a MES ≥ 2, with minimum disease extent of 15 cm and objective evidence of inflammation that can be visualized using central endoscopic imaging system
Age ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, weeks 8, 16, 32, 48, 64, 80, and 96
Awards & highlights

VERDICT 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.Check my eligibility
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.See study design
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.

VERDICT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My ulcerative colitis is active, with bleeding and inflammation seen in a colonoscopy.
Select...
I am 18 years old or older.
Select...
My ulcerative colitis diagnosis was confirmed by tests and doctor's evaluation.

VERDICT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weeks 8, 16, 32, 48, 64, 80, and 96
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, weeks 8, 16, 32, 48, 64, 80, and 96 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Difference in Time to UC-related Complication Between Treatment Target Groups 1 and 3
Secondary outcome measures
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 more

VERDICT 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
11 Previous Clinical Trials
3,789 Total Patients Enrolled
4 Trials studying Ulcerative Colitis
86 Patients Enrolled for Ulcerative Colitis
Takeda Development Center Americas, Inc.Industry Sponsor
56 Previous Clinical Trials
11,370 Total Patients Enrolled
2 Trials studying Ulcerative Colitis
148 Patients Enrolled for Ulcerative Colitis
Vipul Jairath, MDPrincipal InvestigatorAlimentiv Inc.
2 Previous Clinical Trials
1,884 Total Patients Enrolled

Media Library

Treatment Algorithm A (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04259138 — Phase 4
Ulcerative Colitis Research Study Groups: Symptomatic and endoscopic remission, Symptomatic, endoscopic and histological remission, Symptomatic remission
Ulcerative Colitis Clinical Trial 2023: Treatment Algorithm A Highlights & Side Effects. Trial Name: NCT04259138 — Phase 4
Treatment Algorithm A (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04259138 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many volunteers have been recruited for this research initiative?

"To complete this clinical trial, 660 individuals meeting all prerequisites need to be enrolled. Participants can join through Weill Cornell Medicine in New york and TIDHI in Toronto."

Answered by AI

Is this research a pioneering endeavor?

"This therapeutic intervention has been under investigative scrutiny since 2015. With the commencement of a Takeda-funded trial involving 260 participants, it was approved for its fourth phase in drug trials and is now being studied across 42 countries with 23 active investigations occurring in 312 cities."

Answered by AI

In what number of health institutions is this experiment being conducted?

"This medical trial is being carried out at Weill Cornell Medicine in New york, TIDHI in Toronto, Michigan and London Health Sciences Centre - University Campus located in London Alberta. Additionally, there are 13 other sites that are also participating."

Answered by AI

What other empirical investigations have explored this therapeutic approach?

"AZ Sint Lucas was the first to investigate this therapy back in 2015. Since then, a total of 38 clinical trials have been completed, with 23 others still active - many being conducted out of New york City."

Answered by AI

What potential hazards may arise from this treatment?

"Our staff at Power believes that the safety rating of this treatment is a 3, as it has been authorized by Phase 4 trials which provide evidence for both efficacy and security."

Answered by AI

Are there any remaining enrollment opportunities for this research project?

"Affirmative, the information available on clinicaltrials.gov stipulates that this trial is currently recruiting participants. This research project was first advertised on September 17th 2020 and has been recently revised as of April 4th 2022; its objective being to select 660 patients from 13 different medical centres."

Answered by AI

Who else is applying?

What site did they apply to?
GIRI (GI Research Institute)
What portion of applicants met pre-screening criteria?
Met criteria
~130 spots leftby Mar 2025