Optimal Treatment Strategies for Ulcerative Colitis
(VERDICT Trial)

Recruiting in Palo Alto (17 mi)

+69 other locations

Overseen byVipul Jairath

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Alimentiv Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

Disease activity and response to therapy in ulcerative colitis (UC) can be assessed by a range of endpoints including symptoms, endoscopic mucosal activity, histological disease activity, and biomarkers. This study aims to determine the optimal treatment target, which is a research priority for the management of UC both to inform clinical practice and to help inform regulatory endpoints and targets for drug development. Participants with active UC will be randomized in a 5:4:1 (initially 2:3:5) ratio to 1 of 3 groups, each with a different treatment target. Treatment targets will be defined as: * Group 1: corticosteroid-free symptomatic remission * Group 2: corticosteroid-free endoscopic + symptomatic remission * Group 3: corticosteroid-free histological + endoscopic + symptomatic remission An interim analysis was performed to assess the proportion of subjects that reached their assigned treatment target after 50 subjects in each group had reached the first 32-week assessment. The interim analysis and projections made based on target achievement rates for all subjects included in the interim analysis resulted in a recommendation to adjust the randomization ratio from 2:3:5 to 5:4:1 for Groups 1, 2 and 3 respectively as of May 5th, 2023. This change was necessary in order to complete the study with approximately 100 subjects achieving treatment target within each group.

Research Team

Vipul Jairath

Principal Investigator

Alimentiv Inc.

Eligibility Criteria

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.

Inclusion Criteria

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

Written informed consent must be obtained and documented

My ulcerative colitis is active, with bleeding and inflammation seen in a colonoscopy.

See 8 more

Exclusion Criteria

I have short gut syndrome.

I have been treated with vedolizumab, etrolizumab, or natalizumab.

Hypersensitivity to any excipient of vedolizumab

See 17 more

Treatment Details

Interventions

Treatment Algorithm A (Other)
Treatment Algorithm B (Other)
Treatment Algorithm C (Corticosteroid)

Trial OverviewThe 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.

Participant Groups

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.