What side effects are associated with this type of intervention?

Common treatments for Ulcerative Colitis include mesalamine, glucocorticoids, and biologic agents. Mesalamine can cause side effects such as nausea, headache, fever, rash, pancreatitis, and pneumonitis. Glucocorticoids, when used topically or systemically, may lead to adrenal suppression, increased risk of infection, osteoporosis, and other systemic effects if used long-term. Biologic agents, which target specific components of the immune system, can cause infusion reactions, increased risk of infections, and potential development of antibodies against the medication, reducing its effectiveness. Patients should discuss these potential side effects with their healthcare provider to make informed treatment decisions.

What prior FDA approvals exist?

The FDA has approved several treatments for Ulcerative Colitis, including biologics such as infliximab, adalimumab, and vedolizumab, which target TNF-alpha and integrins respectively. Ustekinumab, targeting interleukins IL-12 and IL-23, is also approved. Small molecule drugs like tofacitinib, a Janus kinase inhibitor, have been approved for UC as well. These treatments aim to reduce inflammation and maintain remission in patients with moderate to severe UC.

What other types of research exist?

Promising novel alternatives to VTX002 for Ulcerative Colitis patients include: 1. Ozanimod - a sphingosine 1-phosphate receptor modulator, approved for UC treatment. 2. Ustekinumab - a monoclonal antibody targeting interleukin-12 and interleukin-23, effective in immune-mediated disorders. 3. Risankizumab - an anti-IL-23 monoclonal antibody, recently approved for Crohn's disease and showing potential for UC. These alternatives offer different mechanisms of action and have demonstrated efficacy in clinical trials.

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Unknown

VTX002 for Ulcerative Colitis

Phase 2

Waitlist Available

Research Sponsored by Oppilan Pharma Ltd

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Severe extensive colitis

Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 1, 4, 8, and 13 of the induction treatment period

Summary

This trial tests if taking VTX002 regularly as a tablet is safe and effective for people with moderate to severe ulcerative colitis. The goal is to see if it can reduce symptoms and heal the gut lining.

Who is the study for?

This trial is for people who've had moderate to severe ulcerative colitis (UC) for at least 3 months. They must have active UC confirmed by a special camera test called endoscopy. People with other types of colitis, severe widespread colitis, Crohn's disease, or a history of certain abnormal connections in their intestines can't join.

What is being tested?

The study tests if VTX002 tablets are safe and effective when taken daily by UC patients compared to a placebo (a pill without any medicine). Participants will be randomly assigned to receive either VTX002 at two different doses or placebo and followed up for up to 36 months including various treatment phases.

What are the potential side effects?

While the specific side effects of VTX002 aren't listed here, common side effects from drugs treating UC may include headache, nausea, fatigue, abdominal pain, and possible reactions at the drug's entry point into the body.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe widespread inflammation in my colon.

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I have been diagnosed with a specific type of colitis.

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I have been diagnosed with Crohn's disease or have a history of fistulas related to it.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 1, 4, 8, and 13 of the induction treatment period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 1, 4, 8, and 13 of the induction treatment period

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 1, 4, 8, and 13 of the induction treatment period for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinical Remission at 13 Weeks

Secondary study objectives

Endoscopic Improvement at Week 13

Endoscopic Improvement-Histologic Remission at Week 13

Histologic Remission at Week 13

+2 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: VTX002 Dose BExperimental Treatment1 Intervention

VTX002 Dose B tablet administered orally once daily

Group II: VTX002 Dose AExperimental Treatment1 Intervention

VTX002 Dose A tablet administered orally once daily

Group III: PlaceboPlacebo Group1 Intervention

Placebo tablet administered orally once daily

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Ulcerative Colitis (UC) include aminosalicylates, corticosteroids, immunomodulators, and biologics. Aminosalicylates, like mesalamine, reduce inflammation in the colon by inhibiting the production of inflammatory chemicals. Corticosteroids, such as prednisone, suppress the immune system to decrease inflammation rapidly. Immunomodulators, including azathioprine and 6-mercaptopurine, alter the immune response to prevent ongoing inflammation. Biologics, like anti-TNF agents (infliximab, adalimumab), target specific proteins involved in the inflammatory process. These treatments are crucial for UC patients as they help manage symptoms, induce and maintain remission, and improve quality of life by controlling the chronic inflammation characteristic of the disease.

Emerging Therapies for Inflammatory Bowel Diseases.Novel topical therapies for distal colitis.