Optimal Treatment Strategies for Ulcerative Colitis

(VERDICT Trial)

Not currently recruiting at 77 trial locations

Overseen By Luiza Nita

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Alimentiv Inc.

Must not be taking: Vedolizumab, Etrolizumab, Natalizumab

Disqualifiers: Hepatitis, TB, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 32 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the best treatment for people with ulcerative colitis (UC), a condition that causes inflammation and sores in the colon. Participants will join one of three groups to determine which treatment strategy works best. The groups will test different methods to achieve remission (relief from symptoms without corticosteroids) by evaluating symptoms, colon lining, and tissue health. These strategies are called Treatment Algorithm A, Treatment Algorithm B, and Treatment Algorithm C. Suitable candidates have moderately to severely active UC and are not responding to their current treatment. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, and this research seeks to understand how it benefits more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use topical therapies like corticosteroids or 5-aminosalicylates within 2 weeks before the screening endoscopy. Also, you cannot change your oral corticosteroid dose within 2 weeks before randomization or take more than 30 mg of prednisone or equivalent at randomization.

What is the safety track record for these treatments?

Research shows that treatments for ulcerative colitis (UC) can be safe, but specific data should be examined. For Treatment Algorithm A, studies using real-world data found more safety issues in UC patients compared to those without UC, though these studies lacked specific treatment details.

For Treatment Algorithm B, one study focused on vedolizumab, which is known for its safety and is commonly used for UC. Patients generally tolerate vedolizumab well.

Treatment Algorithm C shares a similar safety profile with the others. While studies did not provide detailed safety outcomes for this treatment, they reported similar general findings about UC treatments.

Since this trial is in a later phase, it suggests these treatments have been found relatively safe in earlier trials. However, discussing any concerns with a healthcare provider is essential. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the Optimal Treatment Strategies for Ulcerative Colitis trial because it explores different approaches to remission that go beyond just managing symptoms. Current treatments like aminosalicylates, corticosteroids, and immunosuppressants mainly focus on controlling inflammation and alleviating symptoms. However, this trial is investigating three treatment algorithms that aim for not only symptomatic remission but also endoscopic and histological remission without the use of corticosteroids. This comprehensive approach could offer more sustainable results and improve long-term health outcomes for patients. By targeting multiple aspects of the disease, these strategies have the potential to redefine what remission means in ulcerative colitis care.

What evidence suggests that this trial's treatments could be effective for ulcerative colitis?

This trial compares different treatment strategies for ulcerative colitis (UC). Treatment Plan A includes medications like vedolizumab, infliximab, ustekinumab, and tofacitinib, aiming to improve quality of life by controlling UC symptoms such as urgent bowel movements and bleeding. Previous studies have shown these drugs to be very effective in managing UC symptoms.

Treatment Plan B also uses vedolizumab, which works well as an initial advanced treatment. Several studies have supported that patients using vedolizumab experience longer periods without disease flare-ups.

Treatment Plan C aims for more complete remission, including healing of the tissue lining the colon. The rates of this tissue healing range from 15% to 44.9%, showing varied success but still making it a promising goal. Overall, multiple studies and real-world settings have proven these treatments effective in managing UC. ^{5 6 7 8 9}

Who Is on the Research Team?

Vipul Jairath

Principal Investigator

Alimentiv Inc.

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

I have short gut syndrome.

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

Hypersensitivity to any excipient of vedolizumab

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized into one of three groups with different treatment targets, including corticosteroid-free symptomatic remission, endoscopic remission, and histological remission.

32 weeks

Interim Analysis

An interim analysis is conducted to assess the proportion of subjects reaching their treatment targets.

Ongoing until 50 subjects per group reach the 32-week assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments including Mayo Clinic Score, Geboes scores, and other histological indices.

Up to 96 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Treatment Algorithm A
• Treatment Algorithm B
• Treatment Algorithm C

Trial Overview 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.

How Is the Trial Designed?

Group I: Symptomatic, endoscopic and histological remission Experimental Treatment 3 Interventions

Treatment target defined as achievement of corticosteroid-free symptomatic remission plus endoscopic remission plus histological remission.

Group II: Symptomatic remission Experimental Treatment 3 Interventions

Treatment target defined as achievement of corticosteroid-free symptomatic remission.

Group III: Symptomatic and endoscopic remission Experimental Treatment 3 Interventions

Treatment target defined as achievement of corticosteroid-free symptomatic remission plus endoscopic remission.

Who Is Running the Clinical Trial?

Alimentiv Inc.

Lead Sponsor

Trials

15

Recruited

3,300+

Takeda Development Center Americas, Inc.

Industry Sponsor

Trials

58

Recruited

10,800+

Published Research Related to This Trial

A systematic review of 83 randomized controlled trials involving 17,737 patients with ulcerative colitis revealed significant variability in the definitions of clinical response and remission, with over 50 different definitions used.

Despite advancements in trial design, there is a need for a standardized core outcome set to improve the consistency of efficacy and safety reporting in clinical trials for ulcerative colitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heterogeneity in Definitions of Endpoints for Clinical Trials of Ulcerative Colitis: A Systematic Review for Development of a Core Outcome Set. Ma, C., Panaccione, R., Fedorak, RN., et al.[2019]

Citations

1. gastrojournal.org gastrojournal.org/article/S0016-5085(21)03842-7/fulltext

IDENTIFYING THE MOST EFFECTIVE TREATMENT ... This study endeavors to identify treatment algorithms when considering the UC therapies of vedolizumab, infliximab, ustekinumab, and tofacitinib.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11842905/

A practical approach to positioning therapies in ulcerative ... In this review, we propose a rational framework for treatment selection, sequencing, and optimization in patients with UC.

3. academic.oup.com academic.oup.com/ibdjournal/article/28/Supplement_1/S11/6514053

IDENTIFYING THE MOST EFFECTIVE TREATMENT ... A Markov model was used to identify the UC treatment algorithm that would potentially yield the greatest quality adjusted life years (QALYs) ...

4. gi.org gi.org/journals-publications/ebgi/alkazzi_aug2025/

The updated 2025 ACG guidelines to manage adult ... Initial treatment of UC should focus on restoration of normal bowel frequency and control of the primary symptoms of bleeding and bowel urgency.

5. karger.com karger.com/dig/article/101/Suppl.%201/2/103681/Treatment-Algorithm-for-Mild-and-Moderate-to

Treatment Algorithm for Mild and Moderate-to-Severe ... Tacrolimus has shown short-term efficacy with clinical response rates reported from 38 to 68% depending on targeted through levels [76] but has ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12558580/

Safety Outcomes in Patients With Ulcerative Colitis Using a ... We used RWD to investigate safety outcomes in 4 cohorts: (1) those receiving any UC treatment (UC overall), (2) those receiving advanced ...

7. academic.oup.com academic.oup.com/ibdjournal/advance-article-abstract/doi/10.1093/ibd/izaf067/8113033

Safety Outcomes in Patients With Ulcerative Colitis Using a ... This large real-world data study found that patients with vs without ulcerative colitis had a higher incidence of most safety outcomes assessed, regardless of ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40222016/

Safety Outcomes in Patients With Ulcerative Colitis Using a ... This large real-world data study found that patients with vs without ulcerative colitis had a higher incidence of most safety outcomes assessed, regardless of ...

9. gastrojournal.org gastrojournal.org/article/S0016-5085(24)05563-X/fulltext

AGA Living Clinical Practice Guideline on Pharmacological ... Safety of Pharmacological Therapies for Moderate-to-Severe Ulcerative Colitis. The guideline panel rated the safety of pharmacological therapies as an important ...